The prominent consumer advocacy group Public Citizen has filed another petition with the FDA calling for a Meridia recall, citing additional information from a recent study that found the weight-loss drug may increase the risk of heart attacks, strokes and other cardiovascular problems.
Dr. Sydney Wolfe, director of the consumer watchdog group Public Citizen, sent a letter to FDA Commissioner Dr. Margaret Hamburg on December 3, pressing for a recall of Meridia from circulation. The petition points to the results of a study known as SCOUT, Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event, which was conducted by the European Medicines Agency and Knoll Pharmaceuitcals, which manufactures the drug.
The FDA issued an Early Communication late last month announcing that they were conducting a review of the potential side effects of Meridia in light of the preliminary findings from the SCOUT study. Although no conclusions had been reached at that time, the FDA indicated that the review would be expedited due to the seriousness of the risk.
Meridia (sibutramine) was approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure.
The SCOUT study was originally done in hopes of showing that weight loss through the use of Meridia actually lowered the risk of cardiovascular events; instead the preliminary data suggested that Meridia side effects actually increase the risk.
Researchers looked at 10,000 patients who were obese and over 55 years old with a history of heart disease or type 2 diabetes and other risk factors. In preliminary results reported to FDA in mid-November, researchers found that 11.4% of patients suffered Meridia heart problems, including heart attack, stroke, resuscitated cardiac arrest and death, compared to only 10% of patients given a placebo. The researchers reported that the result was higher than expected.
“The results of this large trial clearly refute the assumption that drug-induced weight loss with sibutramine reduces these risks,” Wolfe said in the Meridia recall petition. “Worse, the results show that sibutramine significantly increased these risks in the 5,000 people in the trial who used the drug.”
The Public Citizen letter is the organization’s second petition to get Meridia recalled. A 2002 petition was denied by FDA. The drug is listed as a “Do Not Use” drug on the Public Citizen’s “Worst Pills, Best Pills” list.
Public Citizen says that the FDA rejected their 2002 petition, saying that they were waiting for the results of the SCOUT study. Public Citizen argues that now that the study has been released and appears to show that Meridia does more harm than good, it is time for the FDA to make good on taking action.