Showing posts with label Drugs. Show all posts
Showing posts with label Drugs. Show all posts
Thursday, 5 January 2012
0
Thursday, 5 January 2012
Ramit Hooda
San Diego: Arena Pharmaceuticals Inc said on Tuesday it submitted an official response addressing safety concerns of US health regulators over the company`s experimental weight loss drug lorcaserin, and believes it will gain US approval.
Lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co Ltd, is one of three new potential obesity treatments rejected by the Food and Drug Administration over safety issues.
New data included in Arena`s response to the FDA`s complete response letter is intended to alleviate agency concerns over cancerous tumors found in rats in two-year animal studies of lorcaserin.
"With these last group of experiments, which had to do with mammary tumors in female rats, we believe that we have addressed all of the issues that the FDA raised in the complete response letter," Christy Anderson, head of Arena`s lorcaserin development program, said in a telephone interview.
However, the companies cautioned that "the FDA may analyze or weigh the data differently than Arena and Eisai."
Arena expects that the FDA later this month will confirm acceptance of the official response and set a new action date for an approval decision, likely about six months from the time of submission.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States with nearly a third of the population falling into the growing category. But the FDA has set a very high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them.
Many industry observers believe approval of any new weight loss drug is a longshot. Arena`s Chief Executive Jack Lief, however, remains optimistic.
"We believe that lorcaserin will be approved both in this country as well as in Europe and other countries," Lief said.
Vivus Inc and Orexigen Therapeutics are also working to convince the FDA of the worth of their weight loss drugs after initial rejections.
In data submitted to the FDA last week, Arena said it found that the rats that received the highest dose of lorcaserin without developing malignant tumors were getting 24 times more of the drug than a person taking the recommended dose. The rats that did develop tumors were taking even more of the drug than that, Anderson explained.
In addition to demonstrating what they called a safety margin of 24, the companies believe they have shown that the mechanism for tumor formation was relevant to rats but not humans. The drug leads to an increase in the hormone prolactin.
"Prolactin is a hormone that can cause mammary tumors in rats but is not known to cause mammary tumors in people," Anderson said.
In clinical trials of some 7,000 patients taking lorcaserin for up to two years there was "no excess of any sort of tumors in humans," Lief said.
Arena does not believe the FDA will require a lengthy, expensive study to show that its drug does not cause heart problems -- a so-called outcomes study -- as a condition of approval.
"We think that is not likely primarily because we haven`t shown any increase in any risk factors in clinical trials," Lief said.
Added Anderson: "We Showed beneficial effects on blood pressure and heart rate in some of our Phase III studies, so there would be no reason to pursue an outcomes study based on data."
read more
Arena responds to FDA concerns on weight loss drug
Lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co Ltd, is one of three new potential obesity treatments rejected by the Food and Drug Administration over safety issues.
New data included in Arena`s response to the FDA`s complete response letter is intended to alleviate agency concerns over cancerous tumors found in rats in two-year animal studies of lorcaserin.
"With these last group of experiments, which had to do with mammary tumors in female rats, we believe that we have addressed all of the issues that the FDA raised in the complete response letter," Christy Anderson, head of Arena`s lorcaserin development program, said in a telephone interview.
However, the companies cautioned that "the FDA may analyze or weigh the data differently than Arena and Eisai."
Arena expects that the FDA later this month will confirm acceptance of the official response and set a new action date for an approval decision, likely about six months from the time of submission.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States with nearly a third of the population falling into the growing category. But the FDA has set a very high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them.
Many industry observers believe approval of any new weight loss drug is a longshot. Arena`s Chief Executive Jack Lief, however, remains optimistic.
"We believe that lorcaserin will be approved both in this country as well as in Europe and other countries," Lief said.
Vivus Inc and Orexigen Therapeutics are also working to convince the FDA of the worth of their weight loss drugs after initial rejections.
In data submitted to the FDA last week, Arena said it found that the rats that received the highest dose of lorcaserin without developing malignant tumors were getting 24 times more of the drug than a person taking the recommended dose. The rats that did develop tumors were taking even more of the drug than that, Anderson explained.
In addition to demonstrating what they called a safety margin of 24, the companies believe they have shown that the mechanism for tumor formation was relevant to rats but not humans. The drug leads to an increase in the hormone prolactin.
"Prolactin is a hormone that can cause mammary tumors in rats but is not known to cause mammary tumors in people," Anderson said.
In clinical trials of some 7,000 patients taking lorcaserin for up to two years there was "no excess of any sort of tumors in humans," Lief said.
Arena does not believe the FDA will require a lengthy, expensive study to show that its drug does not cause heart problems -- a so-called outcomes study -- as a condition of approval.
"We think that is not likely primarily because we haven`t shown any increase in any risk factors in clinical trials," Lief said.
Added Anderson: "We Showed beneficial effects on blood pressure and heart rate in some of our Phase III studies, so there would be no reason to pursue an outcomes study based on data."
0
Ramit Hooda
New York: Middle aged adults whose memories have grown hazy can`t blame occasional pot smoking or other light illicit drug use, new research suggests.
In a study of nearly 9,000 Britons whose memory and mental function were tested at age 50, researchers found that those who had used illegal drugs as recently as in their 40s did just as well or slightly better on the tests than peers who had never used drugs.
When the participants were surveyed at age 42 about current or past drug use, marijuana was by far the most common indulgence: six percent said they had used it in the past year, while one-quarter said they had ever used it.
Other drugs they were asked about included amphetamines, LSD, hallucinogenic mushrooms, cocaine and ecstasy -- with anywhere from three percent to eight percent of study participants saying they`d ever used those drugs.
While the researchers found no significant difference between drug users and non-users in cognitive tests, they also stress that this doesn`t mean illegal drugs harm no one.
According to one expert not involved in the study, the findings should not be seen as an endorsement of drug use.
"We`re trying to understand where the harms are, and where they aren`t," said Dr. John H. Halpern, a psychiatrist at Harvard Medical School and McLean Hospital in Belmont, Massachusetts, who has studied the potential cognitive effects of drug use.
The current findings suggest that for the occasional drug user at mid-life, there are unlikely to be lasting cognitive consequences, according to Halpern.
"In a Western population of occasional drug users, this is what you`d expect to see," he said.
"In some ways," Halpern said, "this is not surprising. The brain is resilient."
Still, he pointed out, the study could not clearly separate "drug users from abusers."
The British researchers say it`s possible that people who use drugs frequently or for years could see lingering effects on their mental function.
A small subset of participants who said they had ever been treated for their drug use -- which could suggest heavy or addicted drug use -- did not fare as well cognitively at age 50, but there were too few of them to draw meaningful conclusions, the study authors note.
"Overall, at the population level, the results seem to suggest that past or even current illicit drug use is not necessarily associated with impaired cognitive functioning in early middle age," said lead researcher Dr. Alex Dregan, of King`s College London.
"However," he said, "our results do not exclude possible harmful effects in some individuals who may be heavily exposed to drugs over longer periods of time."
For the study, which appears in the American Journal of Epidemiology, Dregan`s team used data on 8,992 42-year-old adults participating in a UK national health study, who were asked whether they had ever used any of 12 illegal drugs.
Then, at the age of 50, participants took standard tests of memory, attention and other cognitive abilities.
Overall, the study found, there was no evidence that current or past drug users had poorer mental performance. In fact, when current and past users were lumped together, their test scores tended to be higher.
But that advantage was small, the researchers say, and might just reflect another finding -- that people who`d ever used drugs generally had a higher education level than non-users.
Though some studies have found that drugs like marijuana and cocaine may cloud thinking, memory and attention in the short term, the current findings support the notion that those effects may be temporary, according to Dregan`s team.
Other research suggests that too. Halpern pointed to work focused on people who`ve smoked pot regularly for years: once they stop the drug, researchers have found, their deficits on cognitive tests improve after a month.
But Halpern agreed that the current results do not rule out the possibility of lasting negative cognitive effects from heavy, prolonged drug use.
There are, of course, other reasons to avoid illegal drugs. As an example, Halpern noted that cocaine can trigger a stroke. And one of the possible consequences of a stroke is long-term cognitive impairment.
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Drug use not tied to mental decline in middle-age
In a study of nearly 9,000 Britons whose memory and mental function were tested at age 50, researchers found that those who had used illegal drugs as recently as in their 40s did just as well or slightly better on the tests than peers who had never used drugs.
When the participants were surveyed at age 42 about current or past drug use, marijuana was by far the most common indulgence: six percent said they had used it in the past year, while one-quarter said they had ever used it.
Other drugs they were asked about included amphetamines, LSD, hallucinogenic mushrooms, cocaine and ecstasy -- with anywhere from three percent to eight percent of study participants saying they`d ever used those drugs.
While the researchers found no significant difference between drug users and non-users in cognitive tests, they also stress that this doesn`t mean illegal drugs harm no one.
According to one expert not involved in the study, the findings should not be seen as an endorsement of drug use.
"We`re trying to understand where the harms are, and where they aren`t," said Dr. John H. Halpern, a psychiatrist at Harvard Medical School and McLean Hospital in Belmont, Massachusetts, who has studied the potential cognitive effects of drug use.
The current findings suggest that for the occasional drug user at mid-life, there are unlikely to be lasting cognitive consequences, according to Halpern.
"In a Western population of occasional drug users, this is what you`d expect to see," he said.
"In some ways," Halpern said, "this is not surprising. The brain is resilient."
Still, he pointed out, the study could not clearly separate "drug users from abusers."
The British researchers say it`s possible that people who use drugs frequently or for years could see lingering effects on their mental function.
A small subset of participants who said they had ever been treated for their drug use -- which could suggest heavy or addicted drug use -- did not fare as well cognitively at age 50, but there were too few of them to draw meaningful conclusions, the study authors note.
"Overall, at the population level, the results seem to suggest that past or even current illicit drug use is not necessarily associated with impaired cognitive functioning in early middle age," said lead researcher Dr. Alex Dregan, of King`s College London.
"However," he said, "our results do not exclude possible harmful effects in some individuals who may be heavily exposed to drugs over longer periods of time."
For the study, which appears in the American Journal of Epidemiology, Dregan`s team used data on 8,992 42-year-old adults participating in a UK national health study, who were asked whether they had ever used any of 12 illegal drugs.
Then, at the age of 50, participants took standard tests of memory, attention and other cognitive abilities.
Overall, the study found, there was no evidence that current or past drug users had poorer mental performance. In fact, when current and past users were lumped together, their test scores tended to be higher.
But that advantage was small, the researchers say, and might just reflect another finding -- that people who`d ever used drugs generally had a higher education level than non-users.
Though some studies have found that drugs like marijuana and cocaine may cloud thinking, memory and attention in the short term, the current findings support the notion that those effects may be temporary, according to Dregan`s team.
Other research suggests that too. Halpern pointed to work focused on people who`ve smoked pot regularly for years: once they stop the drug, researchers have found, their deficits on cognitive tests improve after a month.
But Halpern agreed that the current results do not rule out the possibility of lasting negative cognitive effects from heavy, prolonged drug use.
There are, of course, other reasons to avoid illegal drugs. As an example, Halpern noted that cocaine can trigger a stroke. And one of the possible consequences of a stroke is long-term cognitive impairment.
Wednesday, 4 January 2012
0
Wednesday, 4 January 2012
Ramit Hooda
What is Actos?
Actos (pioglitazone) is an oral diabetes medicine that helps control blood sugar levels.
Actos is for people with type 2 (non-insulin-dependent) diabetes. Pioglitazone is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.
Actos may also be used for purposes not listed in this medication guide.
Important information about Actos
You should not use Actos if you are allergic to pioglitazone, if you have severe heart failure, if you have active bladder cancer, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Do not take Actos for longer than recommended. Taking this medication for longer than 1 year (12 months) may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.
Before taking Actos, tell your doctor if you have congestive heart failure or heart disease, fluid retention, a history of bladder cancer, a history of heart attack or stroke, or liver disease.
Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.
Some women using Actos have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.
Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Actos. Talk with your doctor if you are concerned about this possibility.
Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Actos.
Before taking Actos
You should not use Actos if you are allergic to pioglitazone, if you have severe heart failure, if you have active bladder cancer, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
To make sure you can safely take Actos, tell your doctor if you have any of these other conditions:
congestive heart failure or heart disease;
fluid retention;
a history of bladder cancer;
a history of heart attack or stroke; or
liver disease.
Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Actos.
Some women using Actos have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.
Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Actos. Talk with your doctor if you are concerned about this possibility.
Do not take Actos for longer than recommended. Taking this medication for longer than 1 year (12 months) may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.
FDA pregnancy category C. It is not known whether Actos will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Actos. It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby. Do not take Actos without first talking to your doctor if you are breast-feeding a baby.
How should I take Actos?
Take Actos exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Actos is usually taken once daily. You may take Actos with or without food.
Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.
Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.
Ask your doctor how to adjust your Actos dose if needed. Do not change your medication dose or schedule without your doctor's advice.
Use Actos regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Actos is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
Store Actos at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).
What should I avoid while taking Actos?
Avoid drinking alcohol while taking Actos. It lowers blood sugar and may interfere with your diabetes treatment.
Actos side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Actos: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Actos and call your doctor at once if you have any of these serious side effects:
stomach pain, blood in your urine;
painful urination;
feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
chest pain, general ill feeling;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
blurred vision;
increased thirst or hunger, urinating more than usual; or
pale skin, easy bruising or bleeding, weakness.
Less serious Actos side effects may include:
cold symptoms such as stuffy nose, sneezing, cough, sore throat;
headache;
gradual weight gain;
muscle pain;
back pain; or
tooth problems.
What other drugs will affect Actos?
Tell your doctor about all other medicines you use, especially:
bosentan (Tracleer);
delavirdine (Rescriptor);
digoxin (Lanoxin);
gemfibrozil (Lopid);
midazolam (Versed);
morphine (MS Contin, Kadian, Oramorph);
tolbutamide (Orinase);
trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra);
vancomycin (Vancocin, Lyphocin);
amiloride (Midamor), furosemide (Lasix), or triamterene (Dyrenium);
cimetidine (Tagamet) or ranitidine (Zantac);
fluconazole (Diflucan) or ketoconazole (Nizoral);
nicardipine (Cardene) or nifedipine (Nifedical, Procardia);
procainamide (Procan, Pronestyl, Procanbid), quinidine (Quin-G), or quinine (Qualaquin);
rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);
a non-steroidal anti-inflammatory drug (NSAID) such as celecoxib (Celebrex), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene); or
seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), phenobarbital (Solfoton), primidone (Mysoline), and others.
You may be more likely to have hypoglycemia (low blood sugar) if you take Actos with other drugs that can lower blood sugar, such as:
insulin;
probenecid (Benemid);
some nonsteroidal anti-inflammatory drugs (NSAIDs);
aspirin or other salicylates (including Pepto-Bismol);
a blood thinner (warfarin, Coumadin and others);
heart or blood pressure medication (Accupril, Altace, Lotensin, Prinivil, Vasotec, Zestril, and others);
sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);
a monoamine oxidase inhibitor (MAOI); or
other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), or rosiglitazone (Avandia).
read more
Drugs - Actos
Actos (pioglitazone) is an oral diabetes medicine that helps control blood sugar levels.
Actos is for people with type 2 (non-insulin-dependent) diabetes. Pioglitazone is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes.
Actos may also be used for purposes not listed in this medication guide.
Important information about Actos
You should not use Actos if you are allergic to pioglitazone, if you have severe heart failure, if you have active bladder cancer, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Do not take Actos for longer than recommended. Taking this medication for longer than 1 year (12 months) may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.
Before taking Actos, tell your doctor if you have congestive heart failure or heart disease, fluid retention, a history of bladder cancer, a history of heart attack or stroke, or liver disease.
Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.
Some women using Actos have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.
Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Actos. Talk with your doctor if you are concerned about this possibility.
Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Actos.
Before taking Actos
You should not use Actos if you are allergic to pioglitazone, if you have severe heart failure, if you have active bladder cancer, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
To make sure you can safely take Actos, tell your doctor if you have any of these other conditions:
congestive heart failure or heart disease;
fluid retention;
a history of bladder cancer;
a history of heart attack or stroke; or
liver disease.
Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Actos.
Some women using Actos have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.
Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Actos. Talk with your doctor if you are concerned about this possibility.
Do not take Actos for longer than recommended. Taking this medication for longer than 1 year (12 months) may increase your risk of developing bladder cancer. Talk with your doctor about your specific risk.
FDA pregnancy category C. It is not known whether Actos will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Actos. It is not known whether pioglitazone passes into breast milk or if it could harm a nursing baby. Do not take Actos without first talking to your doctor if you are breast-feeding a baby.
How should I take Actos?
Take Actos exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Actos is usually taken once daily. You may take Actos with or without food.
Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.
Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.
Ask your doctor how to adjust your Actos dose if needed. Do not change your medication dose or schedule without your doctor's advice.
Use Actos regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Actos is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
Store Actos at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).
What should I avoid while taking Actos?
Avoid drinking alcohol while taking Actos. It lowers blood sugar and may interfere with your diabetes treatment.
Actos side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Actos: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Actos and call your doctor at once if you have any of these serious side effects:
stomach pain, blood in your urine;
painful urination;
feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
chest pain, general ill feeling;
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
blurred vision;
increased thirst or hunger, urinating more than usual; or
pale skin, easy bruising or bleeding, weakness.
Less serious Actos side effects may include:
cold symptoms such as stuffy nose, sneezing, cough, sore throat;
headache;
gradual weight gain;
muscle pain;
back pain; or
tooth problems.
What other drugs will affect Actos?
Tell your doctor about all other medicines you use, especially:
bosentan (Tracleer);
delavirdine (Rescriptor);
digoxin (Lanoxin);
gemfibrozil (Lopid);
midazolam (Versed);
morphine (MS Contin, Kadian, Oramorph);
tolbutamide (Orinase);
trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra);
vancomycin (Vancocin, Lyphocin);
amiloride (Midamor), furosemide (Lasix), or triamterene (Dyrenium);
cimetidine (Tagamet) or ranitidine (Zantac);
fluconazole (Diflucan) or ketoconazole (Nizoral);
nicardipine (Cardene) or nifedipine (Nifedical, Procardia);
procainamide (Procan, Pronestyl, Procanbid), quinidine (Quin-G), or quinine (Qualaquin);
rifampin (Rifater, Rifadin, Rifamate) or rifapentine (Priftin);
a non-steroidal anti-inflammatory drug (NSAID) such as celecoxib (Celebrex), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), mefenamic acid (Ponstel), or piroxicam (Feldene); or
seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), phenobarbital (Solfoton), primidone (Mysoline), and others.
You may be more likely to have hypoglycemia (low blood sugar) if you take Actos with other drugs that can lower blood sugar, such as:
insulin;
probenecid (Benemid);
some nonsteroidal anti-inflammatory drugs (NSAIDs);
aspirin or other salicylates (including Pepto-Bismol);
a blood thinner (warfarin, Coumadin and others);
heart or blood pressure medication (Accupril, Altace, Lotensin, Prinivil, Vasotec, Zestril, and others);
sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);
a monoamine oxidase inhibitor (MAOI); or
other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), or rosiglitazone (Avandia).
0
Ramit Hooda
What is acetaminophen?
Acetaminophen is a pain reliever and a fever reducer.
Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.
Acetaminophen may also be used for purposes not listed in this medication guide.
Important information about acetaminophen
There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.
Know the amount of acetaminophen in the specific product you are taking.
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
Before taking acetaminophen
You should not use acetaminophen if you are allergic to it.
Ask a doctor or pharmacist if it is safe for you to take acetaminophen if you have:
liver disease; or
a history of alcoholism.
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen.
It is not known whether acetaminophen will harm an unborn baby. Before using this medicine, tell your doctor if you are pregnant. Acetaminophen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use acetaminophen?
Use acetaminophen exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Do not take more acetaminophen than is recommended. An overdose can damage your liver or cause death.
One acetaminophen pill, suppository, or packet of granules may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
If you are treating a child, use a pediatric form of acetaminophen. Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.
Measure the liquid form of acetaminophen with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.
The chewable tablet must be chewed thoroughly before you swallow it.
Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
Do not take a acetaminophen rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.
Try to empty your bowel and bladder just before using the acetaminophen suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.
For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.
Stop using acetaminophen and call your doctor if:
you still have a fever after 3 days of use;
you still have pain after 7 days of use (or 5 days if treating a child);
you have a skin rash, ongoing headache, or any redness or swelling; or
if your symptoms get worse, or if you have any new symptoms.
Urine glucose tests may produce false results while you are taking acetaminophen. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.
Store acetaminophen at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.
What happens if I miss a dose?
Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
What should I avoid while taking acetaminophen?
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking this medicine.
Acetaminophen side effects
Get emergency medical help if you have any of these signs of an allergic reaction to acetaminophen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:
low fever with nausea, stomach pain, and loss of appetite;
dark urine, clay-colored stools; or
jaundice (yellowing of the skin or eyes).
What other drugs will affect acetaminophen?
There may be other drugs that can interact with acetaminophen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
read more
Drugs - Acetaminophen
Acetaminophen is a pain reliever and a fever reducer.
Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.
Acetaminophen may also be used for purposes not listed in this medication guide.
Important information about acetaminophen
There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.
Know the amount of acetaminophen in the specific product you are taking.
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
Before taking acetaminophen
You should not use acetaminophen if you are allergic to it.
Ask a doctor or pharmacist if it is safe for you to take acetaminophen if you have:
liver disease; or
a history of alcoholism.
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen.
It is not known whether acetaminophen will harm an unborn baby. Before using this medicine, tell your doctor if you are pregnant. Acetaminophen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I use acetaminophen?
Use acetaminophen exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Do not take more acetaminophen than is recommended. An overdose can damage your liver or cause death.
One acetaminophen pill, suppository, or packet of granules may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
If you are treating a child, use a pediatric form of acetaminophen. Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.
Measure the liquid form of acetaminophen with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. You may need to shake the liquid before each use. Follow the directions on the medicine label.
The chewable tablet must be chewed thoroughly before you swallow it.
Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
Do not take a acetaminophen rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.
Try to empty your bowel and bladder just before using the acetaminophen suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.
For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.
Stop using acetaminophen and call your doctor if:
you still have a fever after 3 days of use;
you still have pain after 7 days of use (or 5 days if treating a child);
you have a skin rash, ongoing headache, or any redness or swelling; or
if your symptoms get worse, or if you have any new symptoms.
Urine glucose tests may produce false results while you are taking acetaminophen. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.
Store acetaminophen at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.
What happens if I miss a dose?
Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
What should I avoid while taking acetaminophen?
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking this medicine.
Acetaminophen side effects
Get emergency medical help if you have any of these signs of an allergic reaction to acetaminophen: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:
low fever with nausea, stomach pain, and loss of appetite;
dark urine, clay-colored stools; or
jaundice (yellowing of the skin or eyes).
What other drugs will affect acetaminophen?
There may be other drugs that can interact with acetaminophen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Friday, 30 December 2011
0
Friday, 30 December 2011
Ramit Hooda
New York: In a new study of middle-aged New Jersey men, taking cholesterol-lowering drugs was linked to a lower chance of dying from prostate cancer.
The findings don`t prove that the drugs, called statins, ward off aggressive cancer. But they jibe with previous studies suggesting that getting cholesterol levels under control might help reduce the risk of life-threatening disease, researchers said.
"People may be on these medications for their heart, but it may actually be doing them some good for their prostate," said study author Dr. Stephen Marcella, from the University of Medicine and Dentistry of New Jersey in New Brunswick.
"If a person`s on the fence about taking a statin medication for their heart, this is another potential benefit they may have by taking one of these," he told.
Marcella and his colleagues collected the medical records of 380 men who had died of prostate cancer and another 380 of the same age and race without prostate cancer or with non-lethal cancer.
Most of the men were white and in their mid- to late-60s, on average. Close to one in four of the men in both groups combined had ever taken a statin.
The researchers found that men who died of prostate cancer were half as likely to have taken a statin at any time, and for any duration, than men in the "control" group.
When they accounted for whether or not men were overweight and their other health problems and medications, it turned out that those with fatal cancers were 63 percent less likely to have ever taken a statin, according to findings published in Cancer.
But, Marcella added, "I would not tell a person if they don`t have a risk of heart disease, (if) they don`t have hypertension...to take a statin just to prevent lethal prostate cancer."
The evidence that`s effective, he said, just isn`t there yet.
And even if statins do turn out to help prevent fatal prostate cancer, researchers said, previous studies have suggested they don`t lower a man`s risk of getting less aggressive forms of the disease.
According to the American Cancer Society, about one in every six men will be diagnosed with prostate cancer at some point, and one in every 36 men will die of the disease.
Marcella`s team didn`t have the data to figure out if taking a statin for longer, or starting one earlier, was more beneficial than more limited use of the drugs.
`VERY TRICKY TO SORT OUT`
The researchers also couldn`t tell whether men started using statins before or after they were diagnosed with aggressive cancer.
But they did find that while high-potency, often newer statins were linked to a lower risk of fatal prostate cancer, lower-potency drugs were not. That suggests it`s something about the drugs themselves that lower men`s chances of dying from prostate cancer, Marcella said.
Statins may protect against fatal prostate cancer through their known cholesterol-lowering effects, said Dr. Stephen Freedland, who studies prostate cancer at the Duke University Medical Center in Durham, but wasn`t involved in the new study.
He said that cholesterol is a "key nutrient" for cancer cells, so lower cholesterol levels in the body could prevent more aggressive forms of cancer from developing.
But it`s also possible that statins don`t prevent certain cancers at all, Freedland said, and it`s something else about men who take statins -- for example, if they also change their diet and start exercising -- that explains their lower risk of fatal cancer.
"It gets very, very tricky to sort out," Freedland told Reuters Health.
To prove that statins protect against aggressive cancer would require a large study in which cancer-free men, or those with early-stage disease, are randomly assigned to take statins or not and then tracked for years to see how many of them die from cancer.
That type of study, especially involving healthy, disease-free men, would be very expensive and time consuming, said Dr. Nelly Tan, from the University of California, Los Angeles, who has studied statins and prostate cancer risk.
About one-quarter of adults age 45 and older in the U.S. take statins to lower cholesterol and protect against heart attacks. The drugs run anywhere from $11 to more than $200 per month, and sometimes cause side effects including muscle pain, nausea and gas and liver dysfunction.
Researchers agreed that until there`s clearer evidence for benefit, men with healthy hearts shouldn`t seek out statin prescriptions for the purpose of lowering their prostate cancer risks.
But Freedland said that other strategies for lowering cholesterol -- such as eating better and exercising regularly -- are ways almost everyone can lower their disease risks in the meantime
read more
Statins tied to lower risk of fatal prostate cancer
The findings don`t prove that the drugs, called statins, ward off aggressive cancer. But they jibe with previous studies suggesting that getting cholesterol levels under control might help reduce the risk of life-threatening disease, researchers said.
"People may be on these medications for their heart, but it may actually be doing them some good for their prostate," said study author Dr. Stephen Marcella, from the University of Medicine and Dentistry of New Jersey in New Brunswick.
"If a person`s on the fence about taking a statin medication for their heart, this is another potential benefit they may have by taking one of these," he told.
Marcella and his colleagues collected the medical records of 380 men who had died of prostate cancer and another 380 of the same age and race without prostate cancer or with non-lethal cancer.
Most of the men were white and in their mid- to late-60s, on average. Close to one in four of the men in both groups combined had ever taken a statin.
The researchers found that men who died of prostate cancer were half as likely to have taken a statin at any time, and for any duration, than men in the "control" group.
When they accounted for whether or not men were overweight and their other health problems and medications, it turned out that those with fatal cancers were 63 percent less likely to have ever taken a statin, according to findings published in Cancer.
But, Marcella added, "I would not tell a person if they don`t have a risk of heart disease, (if) they don`t have hypertension...to take a statin just to prevent lethal prostate cancer."
The evidence that`s effective, he said, just isn`t there yet.
And even if statins do turn out to help prevent fatal prostate cancer, researchers said, previous studies have suggested they don`t lower a man`s risk of getting less aggressive forms of the disease.
According to the American Cancer Society, about one in every six men will be diagnosed with prostate cancer at some point, and one in every 36 men will die of the disease.
Marcella`s team didn`t have the data to figure out if taking a statin for longer, or starting one earlier, was more beneficial than more limited use of the drugs.
`VERY TRICKY TO SORT OUT`
The researchers also couldn`t tell whether men started using statins before or after they were diagnosed with aggressive cancer.
But they did find that while high-potency, often newer statins were linked to a lower risk of fatal prostate cancer, lower-potency drugs were not. That suggests it`s something about the drugs themselves that lower men`s chances of dying from prostate cancer, Marcella said.
Statins may protect against fatal prostate cancer through their known cholesterol-lowering effects, said Dr. Stephen Freedland, who studies prostate cancer at the Duke University Medical Center in Durham, but wasn`t involved in the new study.
He said that cholesterol is a "key nutrient" for cancer cells, so lower cholesterol levels in the body could prevent more aggressive forms of cancer from developing.
But it`s also possible that statins don`t prevent certain cancers at all, Freedland said, and it`s something else about men who take statins -- for example, if they also change their diet and start exercising -- that explains their lower risk of fatal cancer.
"It gets very, very tricky to sort out," Freedland told Reuters Health.
To prove that statins protect against aggressive cancer would require a large study in which cancer-free men, or those with early-stage disease, are randomly assigned to take statins or not and then tracked for years to see how many of them die from cancer.
That type of study, especially involving healthy, disease-free men, would be very expensive and time consuming, said Dr. Nelly Tan, from the University of California, Los Angeles, who has studied statins and prostate cancer risk.
About one-quarter of adults age 45 and older in the U.S. take statins to lower cholesterol and protect against heart attacks. The drugs run anywhere from $11 to more than $200 per month, and sometimes cause side effects including muscle pain, nausea and gas and liver dysfunction.
Researchers agreed that until there`s clearer evidence for benefit, men with healthy hearts shouldn`t seek out statin prescriptions for the purpose of lowering their prostate cancer risks.
But Freedland said that other strategies for lowering cholesterol -- such as eating better and exercising regularly -- are ways almost everyone can lower their disease risks in the meantime
Wednesday, 28 December 2011
0
Wednesday, 28 December 2011
Ramit Hooda
New York: Avastin, the blockbuster drug that just lost approval for treating breast cancer, now looks disappointing against ovarian cancer, too. Two studies found it did not improve survival for most of these patients and kept their disease from worsening for only a few months, with more side effects.
The Genentech drug won approval in Europe last week for advanced ovarian cancer. But its maker has no immediate plans to seek the same approval in the United States. After talking with the Food and Drug Administration, "we do not believe the data will support approval" although no final decision has been made, said Charlotte Arnold, a spokeswoman for Genentech, part of the Swiss company Roche.
Results of the studies are in Thursday`s New England Journal of Medicine.
In November, the FDA revoked Avastin`s approval for breast cancer because it did not meaningfully extend life and can have serious side effects. Without approval, doctors can prescribe the drug but insurers may not pay. Treatment with it can cost $100,000 a year.
Avastin can still be sold for some colon, lung, kidney and brain cancers. The new research was aimed at adding ovarian cancer to the list.
One study, led by Dr. Robert Burger of Fox Chase Cancer Center in Philadelphia, involved nearly 1,900 women with advanced ovarian cancer given one of three treatment combinations. The time until the disease got worse was a median of 10 months in those given just chemotherapy; adding Avastin improved that by just one to four months for the other two groups.
Survival was similar among the groups, and side effects were higher among those on Avastin — mostly high blood pressure but also some stomach and gut problems that needed treatment.
In the other study, led by researchers from England, more than 1,500 ovarian cancer patients were given chemo with or without Avastin. The drug kept cancer at bay just one to two months longer than chemo alone did, with more cases of high blood pressure. There was a trend toward improved survival for those on Avastin, but the difference was too small to say the drug was responsible.
Genentech helped pay for the studies and some of the researchers consult for the company.
Dr. Gary Lyman, a Duke University researcher who was on the FDA advisory panel that recommended revoking Avastin`s approval for breast cancer, wrote in an email that he agreed with the company`s decision not to seek approval for ovarian cancer.
"The situation is very similar" to the results in breast cancer, and approval is unlikely unless a biological marker or test can show which patients might benefit, he wrote.
About 220,000 new cases of ovarian cancer are diagnosed each year around the world, and it causes 140,000 deaths. In the United States, the National Cancer Institute estimates 22,000 new cases and 15,000 deaths each year.
read more
Avastin disappoints against ovarian cancer
The Genentech drug won approval in Europe last week for advanced ovarian cancer. But its maker has no immediate plans to seek the same approval in the United States. After talking with the Food and Drug Administration, "we do not believe the data will support approval" although no final decision has been made, said Charlotte Arnold, a spokeswoman for Genentech, part of the Swiss company Roche.
Results of the studies are in Thursday`s New England Journal of Medicine.
In November, the FDA revoked Avastin`s approval for breast cancer because it did not meaningfully extend life and can have serious side effects. Without approval, doctors can prescribe the drug but insurers may not pay. Treatment with it can cost $100,000 a year.
Avastin can still be sold for some colon, lung, kidney and brain cancers. The new research was aimed at adding ovarian cancer to the list.
One study, led by Dr. Robert Burger of Fox Chase Cancer Center in Philadelphia, involved nearly 1,900 women with advanced ovarian cancer given one of three treatment combinations. The time until the disease got worse was a median of 10 months in those given just chemotherapy; adding Avastin improved that by just one to four months for the other two groups.
Survival was similar among the groups, and side effects were higher among those on Avastin — mostly high blood pressure but also some stomach and gut problems that needed treatment.
In the other study, led by researchers from England, more than 1,500 ovarian cancer patients were given chemo with or without Avastin. The drug kept cancer at bay just one to two months longer than chemo alone did, with more cases of high blood pressure. There was a trend toward improved survival for those on Avastin, but the difference was too small to say the drug was responsible.
Genentech helped pay for the studies and some of the researchers consult for the company.
Dr. Gary Lyman, a Duke University researcher who was on the FDA advisory panel that recommended revoking Avastin`s approval for breast cancer, wrote in an email that he agreed with the company`s decision not to seek approval for ovarian cancer.
"The situation is very similar" to the results in breast cancer, and approval is unlikely unless a biological marker or test can show which patients might benefit, he wrote.
About 220,000 new cases of ovarian cancer are diagnosed each year around the world, and it causes 140,000 deaths. In the United States, the National Cancer Institute estimates 22,000 new cases and 15,000 deaths each year.
Saturday, 24 December 2011
0
Saturday, 24 December 2011
Ramit Hooda
What is Abilify?
Abilify (aripiprazole) is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
Abilify is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). It is also used together with other medications to treat major depressive disorder in adults.
Abilify is also used to treat irritability and symptoms of aggression, mood swings, temper tantrums, and self-injury related to autistic disorder in children who are at least 6 years old.
Abilify may also be used for purposes not listed in this medication guide.
Important information about Abilify
Abilify is not for use in psychotic conditions that are related to dementia. Abilify may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.
Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance. Abilify may impair your thinking or reactions.
Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol, which can increase some of the side effects of Abilify. Before you take this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Abilify. Avoid becoming overheated or dehydrated.
Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.
Before taking Abilify
Abilify is not for use in psychotic conditions that are related to dementia. Abilify may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not take this medicine if you are allergic to aripiprazole.
To make sure you can safely take Abilify, tell your doctor if you have any of these other conditions:
liver or kidney disease;
heart disease, high blood pressure, heart rhythm problems;
a history of low white blood cell (WBC) counts;
a history of heart attack or stroke;
a history of breast cancer;
seizures or epilepsy;
a personal or family history of diabetes; or
trouble swallowing.
The liquid form (oral solution) of Abilify may contain up to 15 grams of sugar per dose. Before taking Abilify oral solution, tell your doctor if you have diabetes. The orally disintegrating tablet form of this medicine may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria.
Abilify may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking Abilify.
Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Abilify, do not stop taking it without your doctor's advice.
FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Aripiprazole can pass into breast milk and may harm a nursing baby. Do not use Abilify without telling your doctor if you are breast-feeding a baby.
How should I take Abilify?
Take Abilify exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results.
Do not take Abilify for longer than 6 weeks unless your doctor has told you to.
Abilify can be taken with or without food.
Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.
To take aripiprazole orally disintegrating tablets (Abilify Discmelt):
Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.
Use Abilify regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.
Store Abilify tablets at room temperature away from moisture and heat.
Abilify liquid should be stored in the refrigerator and can be used for up to 6 months after opening.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include drowsiness, vomiting, agitation, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), trouble breathing, or fainting.
What should I avoid while taking Abilify?
Abilify may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Drinking alcohol can increase certain side effects of Abilify. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.
Abilify side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Abilify: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Abilify and call your doctor at once if you have a serious side effect such as:
fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
jerky muscle movements you cannot control;
sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
increased thirst or urination, loss of appetite, fruity breath odor, drowsiness, dry skin, nausea, and vomiting;
seizure (convulsions);
thoughts of hurting yourself;
feeling like you might pass out;
jaundice (yellowing of your skin or eyes); or
urinating less than usual or not at all.
Less serious Abilify side effects may include:
choking or trouble swallowing;
dizziness, drowsiness, or weakness;
constipation, mild stomach upset;
headache, anxiety;
sleep problems (insomnia); or
weight gain.
What other drugs will affect Abilify?
Before you take Abilify, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Abilify.
Tell your doctor about all other medicines you use, especially:
a medication to treat high blood pressure or a heart condition;
carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin);
rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);
ketoconazole (Nizoral), itraconazole (Sporanox);
quinidine (Quin-G); or
fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), or paroxetine (Paxil).
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Drugs - Abilify
Abilify (aripiprazole) is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
Abilify is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). It is also used together with other medications to treat major depressive disorder in adults.
Abilify is also used to treat irritability and symptoms of aggression, mood swings, temper tantrums, and self-injury related to autistic disorder in children who are at least 6 years old.
Abilify may also be used for purposes not listed in this medication guide.
Important information about Abilify
Abilify is not for use in psychotic conditions that are related to dementia. Abilify may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.
Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance. Abilify may impair your thinking or reactions.
Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol, which can increase some of the side effects of Abilify. Before you take this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Abilify. Avoid becoming overheated or dehydrated.
Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.
Before taking Abilify
Abilify is not for use in psychotic conditions that are related to dementia. Abilify may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not take this medicine if you are allergic to aripiprazole.
To make sure you can safely take Abilify, tell your doctor if you have any of these other conditions:
liver or kidney disease;
heart disease, high blood pressure, heart rhythm problems;
a history of low white blood cell (WBC) counts;
a history of heart attack or stroke;
a history of breast cancer;
seizures or epilepsy;
a personal or family history of diabetes; or
trouble swallowing.
The liquid form (oral solution) of Abilify may contain up to 15 grams of sugar per dose. Before taking Abilify oral solution, tell your doctor if you have diabetes. The orally disintegrating tablet form of this medicine may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria.
Abilify may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking Abilify.
Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Abilify, do not stop taking it without your doctor's advice.
FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Aripiprazole can pass into breast milk and may harm a nursing baby. Do not use Abilify without telling your doctor if you are breast-feeding a baby.
How should I take Abilify?
Take Abilify exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results.
Do not take Abilify for longer than 6 weeks unless your doctor has told you to.
Abilify can be taken with or without food.
Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.
To take aripiprazole orally disintegrating tablets (Abilify Discmelt):
Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.
Use Abilify regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.
Store Abilify tablets at room temperature away from moisture and heat.
Abilify liquid should be stored in the refrigerator and can be used for up to 6 months after opening.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include drowsiness, vomiting, agitation, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), trouble breathing, or fainting.
What should I avoid while taking Abilify?
Abilify may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Drinking alcohol can increase certain side effects of Abilify. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Abilify.
Abilify side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Abilify: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Abilify and call your doctor at once if you have a serious side effect such as:
fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
jerky muscle movements you cannot control;
sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
increased thirst or urination, loss of appetite, fruity breath odor, drowsiness, dry skin, nausea, and vomiting;
seizure (convulsions);
thoughts of hurting yourself;
feeling like you might pass out;
jaundice (yellowing of your skin or eyes); or
urinating less than usual or not at all.
Less serious Abilify side effects may include:
choking or trouble swallowing;
dizziness, drowsiness, or weakness;
constipation, mild stomach upset;
headache, anxiety;
sleep problems (insomnia); or
weight gain.
What other drugs will affect Abilify?
Before you take Abilify, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Abilify.
Tell your doctor about all other medicines you use, especially:
a medication to treat high blood pressure or a heart condition;
carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin);
rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);
ketoconazole (Nizoral), itraconazole (Sporanox);
quinidine (Quin-G); or
fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), or paroxetine (Paxil).
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