FDA Decision to Recall Meridia Came Too Late for Some: Public Citizen

The prominent consumer advocacy group Public Citizen is criticizing the FDA over how long it took the federal drug regulatory agency to recall Meridia, a prescription weight-loss drug that has been linked to an increased risk of heart attacks and strokes. The FDA may have cost countless lives by waiting years after evidence showed that there was an unacceptable risk of heart problems with Meridia, according to Public Citizen.

Meridia (sibutramine), which was manufactured by Abbott Laboratories, was first 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. On Friday, the FDA announced that the drug would be recalled due to an increased risk of cardiovascular problems, while providing very little actual weight loss benefit for consumers.

Public Citizen, a non-profit organization focused on consumer protection, said in a press release that the FDA should have heeded its earlier calls for a recall of Meridia. The group first called for Meridia to be banned in 2002, after identifying a growing number of post-marketing cases of heart attacks among relatively young patients with no other explanation. After the FDA denied the 2002 petition, Public Citizen re-petitioned for Merdia to be recalled in December 2009.

“Since (the original 2002 petition), more than 3 million prescriptions have been filled for Meridia, with many patients inevitably having had heart attacks or strokes because of its known toxicity,” said Dr. Sidney Wolfe, Direct of Public Citizen’s Health Research Group. “Even since January of this year (after our December 2009 re-petition to ban the drug), when the European Medicines Agency decided to withdraw the drug from Europe, there have been more than 160,000 prescriptions filled for Meridia in the U.S.”

Late last year, the findings of a clinical trial called SCOUT found that Meridia increased the risk of serious heart events, such as heart attacks and strokes, by 16%, while finding only a small difference in the weight loss between people given Meridia and those given a placebo. The FDA said that the SCOUT data and the agency’s subsequent review led it to the decision to ask Abbott Laboratories to remove Meridia, which it reluctantly has agreed to do.

Public Citizen said that the health risks of Meridia have been obvious for years, and that the same pre-approval clinical trials which led to Public Citizen’s first petition were available to the FDA, and had raised concerns as early as 1997 from FDA advisory committees and drug reviewers. However, the non-profit group accuses the FDA’s Office of New Drugs (OND) of interfering with the Office of Surveillance and Epidemiology (OSE), which had been recommending a Meridia recall for some time. OND also overrode OSE’s recommendations for an Avandia recall, Public Citizen claims.

Public Citizen’s concerns over the OND’s ability to prevent OSE from doing its job have been echoed by some lawmakers, and there have been suggestions that any congressional FDA reforms include ensuring that the OSE can operate without fear that the OND can override its decisions.

Although Abbott did agree to recall Meridia late last week, they have fought hard to keep the drug on the market. The drug maker released a statement on Friday indicating that they disagree with the FDA’s decision, but will comply.