The anti-obesity drug Meridia (sibutramine) has been voluntarily withdrawn from the shelves of U.S. markets by its producer Abbott Laboratories in compliance with the recommendation of the U.S. Food and Drug Administration.
Abbott Laboratories has also agreed to stop marketing the obesity drug because of new findings of the post clinical studies that indicated an increased predisposition to heart attack and stroke for individuals taking the drug.
John Jenkins M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER) said, “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke. Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.”
The U.S. FDA approved the drug in November 1997 for weight loss and maintenance of weight loss in obese individuals including individuals who suffer from being overweight and possessing cardiovascular risk factors. The FDA’s approval stems from the five percent weight loss of people receiving sibutramine in comparison to those receiving placebo and undergoing diet and exercise as the data of the clinical trial shows.
The newest FDA recommendation against the drug is based on new data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). Europe’s approval to the drug launched the post market analysis of further effects of the drug which uncovered the 16 percent increased risk in serious episodes of cardiovascular events that encompasses non-fatal stroke, non-fatal heart attack, resuscitation after the heart stopped beating and death for individuals taking the drug in comparison to the placebo group.
Furthermore, there is also data that there is little difference in body weight change between the two groups.
Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER, stated, “The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combine with other available safety data raised serious question about Meridia’s safety for all patient groups.”