jasmine
01-24-2010, 08:57 PM
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FDA Adds Heart Attack Warning to Meridia Diet Pill
Posted on Jan 22nd 2010 4:00PM by Deborah Dunham
Filed Under: Diet & Weight Loss
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If you have concerns about the safety of diet pills, here's another one to add to the list: The FDA is now warning that Meridia, a popular prescription weight-loss drug related to the amphetamine family of stimulants, increases the risk for heart attack and stroke among certain users.
The news came after a recent study of 10,000 patients showed a slightly higher risk of heart-related problems in those taking the drug. As a result, the FDA has now requested that Abbott Laboratories, the manufacturer of Meridia, add new warnings to its label stating the drug should not be taken by anyone with heart failure, hypertension, irregular heart beats and other problems. This comes 10 years after they originally approved the drug, which was issued to 250,000 patients in the U.S. alone last year.
"Anti-obesity agents are put under extreme scrutiny," said Caroline Apovian, M.D., associate professor of medicine at the Boston University School of Medicine. "It's warranted of course, but with 32 percent of the population eligible for an anti-obesity drug, one drug cannot be safe for this entire population."
Meanwhile, marketing of the diet pill (also known as sibutramine) has already ceased in European markets. Doctors and pharmacists there have been urged by the European Medicines Agency to stop recommending it to patients after citing "the risks of these medicines are greater than their benefits."
But the North Carolina-based manufacturer stands by its product, saying it's only approved for those with no history of heart disease. "We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee's opinion and the recommendation to suspend the medicine," Abbott spokesman Kurt Ebenhoch told the Associated Press.
This is not the first time a group has petitioned to stop the drug from being marketed. After reporting last year that 84 deaths have been associated with Meridia, U.S. consumer advocacy group, Public Citizen, urged the FDA to pull Meridia off the market. The FDA ignored their requests in a move that Dr. Sidney Wolfe, the group's health care specialist and research director called a "cop out".
"Physicians are ultra-conservative when prescribing any kind of anti-obesity drug because of all the warnings and risks," said Apovian. "Add that to the fact that insurance doesn't cover these types of drugs, and this could lead more people into choosing over-the-counter weight-loss supplements instead, which could mean even more harmful effects in the end."
For now, the FDA is urging patients to talk to their doctors about whether they should continue taking the drug or not. "The results of this trial are good information, but that doesn't mean a drug like Meridia should be totally pulled from the market. It just has to be prescribed cautiously," Apovian added. "It's not for everyone."
FDA Adds Heart Attack Warning to Meridia Diet Pill
Posted on Jan 22nd 2010 4:00PM by Deborah Dunham
Filed Under: Diet & Weight Loss
Print Email More
If you have concerns about the safety of diet pills, here's another one to add to the list: The FDA is now warning that Meridia, a popular prescription weight-loss drug related to the amphetamine family of stimulants, increases the risk for heart attack and stroke among certain users.
The news came after a recent study of 10,000 patients showed a slightly higher risk of heart-related problems in those taking the drug. As a result, the FDA has now requested that Abbott Laboratories, the manufacturer of Meridia, add new warnings to its label stating the drug should not be taken by anyone with heart failure, hypertension, irregular heart beats and other problems. This comes 10 years after they originally approved the drug, which was issued to 250,000 patients in the U.S. alone last year.
"Anti-obesity agents are put under extreme scrutiny," said Caroline Apovian, M.D., associate professor of medicine at the Boston University School of Medicine. "It's warranted of course, but with 32 percent of the population eligible for an anti-obesity drug, one drug cannot be safe for this entire population."
Meanwhile, marketing of the diet pill (also known as sibutramine) has already ceased in European markets. Doctors and pharmacists there have been urged by the European Medicines Agency to stop recommending it to patients after citing "the risks of these medicines are greater than their benefits."
But the North Carolina-based manufacturer stands by its product, saying it's only approved for those with no history of heart disease. "We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee's opinion and the recommendation to suspend the medicine," Abbott spokesman Kurt Ebenhoch told the Associated Press.
This is not the first time a group has petitioned to stop the drug from being marketed. After reporting last year that 84 deaths have been associated with Meridia, U.S. consumer advocacy group, Public Citizen, urged the FDA to pull Meridia off the market. The FDA ignored their requests in a move that Dr. Sidney Wolfe, the group's health care specialist and research director called a "cop out".
"Physicians are ultra-conservative when prescribing any kind of anti-obesity drug because of all the warnings and risks," said Apovian. "Add that to the fact that insurance doesn't cover these types of drugs, and this could lead more people into choosing over-the-counter weight-loss supplements instead, which could mean even more harmful effects in the end."
For now, the FDA is urging patients to talk to their doctors about whether they should continue taking the drug or not. "The results of this trial are good information, but that doesn't mean a drug like Meridia should be totally pulled from the market. It just has to be prescribed cautiously," Apovian added. "It's not for everyone."