Meridia Heart Side Effects Lead to Call for Recall

By Austin Kirk
Posted December 4, 2009

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Recent research has found that side effects of Meridia, a prescription weight loss drug, may increase the risk of cardiovascular events, such as heart attacks, strokes, resuscitated cardiac arrest and death. Given the limited weight-loss benefits provided by the pill, compared to the substantial risk it may pose for consumers, many are calling for a Meridia recall to be issued.

Meridia (sibutramine) is a prescription-only weight-loss supplement that was approved by the FDA in 1997. The FDA issued an early communication on November 20, indicating that they were reviewing the potential Meridia heart side effects after preliminary data from a recent study found that more users suffered heart problems when compared to the use of a sugar pill.

According to a statement posted on the FDA website after they received the data from a recent study, known as SCOUT, the agency indicated:

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA understands the serious nature of the preliminary data and is conducting an expedited safety review. FDA will communicate its findings to the public as soon as this review is complete.

This week, the consumer advocacy group Public Citizen, which has a strong track record of paving the way for stronger warnings or recalls for dangerous products, filed a petition with the FDA calling for a Meridia recall. In arguing that the risks of Meridia heart problems outweigh the benefits provided by the drug, Public Citizen wrote:

SCOUT (the study which found an increased rate of cardiovascular events) had previously been described by the FDA as “the first trial to verify or refute the long-held assumption that drug-induced weight loss—in this case, with sibutramine (Meridia)—reduces the risk for fatal and nonfatal cardiovascular disease.”

The results of this large trial clearly refute the assumption that drug-induced weight loss with sibutramine reduces these risks. Worse, the results show that sibutramine significantly increased these risks in the 5,000 people in the trial who used the drug.

In addition to the new findings from the SCOUT study (obese people, aged 55 or older), we have found that there are now, as of June 30, 2009, a total of 84 reports of deaths from cardiovascular causes in the FDA Adverse Event Reactions (AERS) database, including 30 in people 50 or younger. Of these 30 people, 11 were 30 or younger. It must be noted that FDA’s own estimates are that no more than one in 10 adverse reactions to drugs that occur are reported to the agency. These data are incomplete as the age is missing from 22 of the 35 most recent FDA sibutramine cardiovascular death reports.

Public Citizen originally filed a petition for a recall of Meridia in March 2002 and filed a supplement to the petition in September 2003. More than two years later, the FDA denied the petition to ban Meridia, suggesting that an “unbiased, objective assessment of sibutramine’s (Meridia)’s cardiovascular safety profile” would be accomplished by the SCOUT study.

While the purpose of the SCOUT study was to show that weight loss through use of Meridia may lower the risk of cardiovascular events, the study actually found that it increased the number and percentage of heart attacks, strokes, resuscitated cardiac arrest or death. This should lead the FDA to require a Meridia recall.