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Subscribe To Our Syndicated NewsFDA denies Public Citizen's petition to ban Meridia
–August 17, 2005
The FDA has denied Public Citizen consumer group's petition to ban Abbott Laboratories' weight loss drug Meridia from the U.S. market.
The group petitioned the FDA to ban the drug because of safety concerns that it caused heart attacks and strokes in some patients. According to Public Citizen, there has been an absence of evidence prior to Meridia's approval and after to indicate the drug's benefits outweigh its risks.
The FDA said it could not conclude that the reports of heart attacks and strokes were caused by Meridia, noting the events are common among patients with obesity, but Public Citizen called the agency's rejection of the Meridia petition "misguided."
Even before Meridia was approved in 1997, an FDA advisory committee voted 5-4 that the benefits of the drug did not outweigh the risks. Public Citizen first petitioned the FDA to remove Meridia from the market in 2002 when Italian health authorities temporarily stopped the marketing of the drug after reports of two patient deaths.
The FDA received 224 reports of non-fatal heart attacks and strokes from November 1997 through August 2003 among Meridia users and 54 reports of deaths, including 30 that were cardiovascular related.
Last year FDA scientist and whistleblower David Graham questioned whether Meridia was effective enough to remain on the market during Congressional testimony about how the agency handled safety questions surrounding Merck & Co.'s September withdrawal of its popular painkiller Vioxx. Wolfe said in a statement "the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug."
Abbott said about 15 million patients in more than 75 countries have used Meridia. The FDA said it is "plausible" that Meridia could raise the risk for some cardiac events, and Abbott said patients using Meridia should be regularly monitored for increased blood pressure and heart rate.
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