The Food and Drug Administration is urging a stronger warning label on Meridia, a popular diet drug, in response to reports of an increased risk of heart attacks and strokes, the New York Times reported.
Pharmaceutical companies spend millions developing drugs and millions more promoting them. But the industry has a long history of recalling popular drugs because of dangerous or fatal side effects, including the 2004 Vioxx recall (also because of an increased risk of heart attack and stroke) and Fen-Phen (another popular diet drug recalled because of the potential risk of liver damage).
New York City medical malpractice attorneys are often called upon to help clients who have suffered injury as a result of a drug interaction or other negligence on the part of doctors, hospitals and pharmacies.
In this case, the European Medicines Agency advised doctors and pharmacists to stop prescribing Meridia while the FDA took a less forceful step in response to the study, asking Meridia's maker, Abbott Laboratories, to put a stronger warning on its label.
The new warning will indicate that the drug should not to be used by people who have a history of heart attacks or strokes, or who have uncontrolled high blood pressure.
Abbott said it would comply with the new requirements in the United States and stop selling the drug in Europe. The company said the drug was safe and effective when used in appropriate patients.
"We believe there are many patients who benefit from sibutramine," said Dr. Eugene Sun, vice president for global pharmaceutical research and development at Abbott.
The company's global sales of the class of sibutramine drugs to which Meridia belongs were about $300 million last year.
The study, called the Scout trial, was the first to actually test the long-held presumption that such diet drugs would also help reduce the health risks of obesity, including heart attacks. Some experts said the results actually found an increase in such risks for some high-risk patients, according to the Times.
The results could call into question the safety of other diet drugs and might make it harder for new obesity drugs to win approval. However, others said the issue might be unique to Meridia, which clearly raises blood pressure and heart rate.
If you or a loved one has suffered medical malpractice or medical negligence, call the New York City medical malpractice lawyers at Queller, Fisher, Washor, Fuchs & Kool for a free and confidential appointment to discuss your rights. Call 866-LifeLaw (866-543-3529).
