August 18, 2005

The FDA denied a consumer group's citizen petition calling for the withdrawal of Abbott Laboratories' obesity treatment Meridia, but said it would continue to closely monitor the drug for future safety problems, according to documents released recently.

Public Citizen petitioned the FDA in March 2002 demanding that Meridia (sibutramine) be removed from the market because it has been linked to severe cardiovascular problems. The group contends Meridia has played a role in more than 50 cardiovascular-related deaths since it was approved eight years ago.

But the FDA concluded "sibutramine's overall risk-benefit profile supports it remaining available as a prescription drug for the treatment of appropriately selected obese patients," Steven Galson, director of the FDA's Center for Drug Evaluation and Research, wrote in the agency's response to the petition.

Public Citizen strongly criticized the agency's decision, saying there is currently no evidence suggesting Meridia is safe enough to remain on the market. In fact, the group said the FDA failed to acknowledge a Meridia safety study published last year by researchers at the University of Washington.

The controversy surrounding Meridia dates back to before the drug was ever approved. An FDA advisory panel that reviewed the drug prior to approval concluded in a 5-4 vote that the benefits of Meridia did not outweigh its risks. The FDA medical officer who reviewed Abbott's application wrote that "sibutramine has an unsatisfactory risk-benefit ratio and therefore this reviewer recommends non-approval of the original submission." The agency, however, ultimately decided to act against the panel's recommendation and approved the drug in 1997.

Abbott has maintained Meridia is safe when used according to current prescribing information, which indicates the drug is only for patients who need to lose 30 pounds or more and should be used in conjunction with a reduced calorie diet. Meridia's labeling also indicates the drug substantially increases blood pressure or heart rate in some patients and should not be given to patients with uncontrolled or poorly controlled hypertension, history of heart disease, stroke, severe liver or kidney disease, or to pregnant women or nursing mothers.