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October 8, 2010
Thanks to eight years of relentless pressure from Public Citizen and others, the Food and Drug Administration (FDA) banned Meridia (generic name: sibutramine). We told Worst Pills readers to avoid the drug 12 years ago.
The FDA approved Meridia in 1997 despite randomized trial evidence of significantly increased blood pressure and heart rate, which are both risk factors for heart attacks.
When approving the drug, the FDA also ignored the opposition of the FDA...
October 8, 2010
Thanks to eight years of relentless pressure from Public Citizen and others, the Food and Drug Administration (FDA) banned Meridia (generic name: sibutramine). We told Worst Pills readers to avoid the drug 12 years ago.
The FDA approved Meridia in 1997 despite randomized trial evidence of significantly increased blood pressure and heart rate, which are both risk factors for heart attacks.
When approving the drug, the FDA also ignored the opposition of the FDA medical officer who reviewed the drug and the FDA’s advisory committee. Our 2002 petition to the FDA to ban the drug included this information and the growing number of heart attacks with no other explanation in relatively young patients taking Meridia.
Since 2002, more than 3 million prescriptions have been filled for Meridia, with many patients inevitably suffering heart attacks or strokes because of its known toxicity.
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.
The FDA’s decision today to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but too late for the victims of its unacceptable risks. It appears that it was banned only because of a rare agreement between different offices in the FDA to ban the drug.
In both of the other cases in which drugs have recently been taken off the market in Europe - Darvon (propoxyphene) and Avandia (rosiglitazone) – the FDA failed to ban the drugs, even though the FDA’s Office of New Drugs voted to ban the drugs. Thus, both of these unacceptably dangerous drugs remain on the market in this country, predictably injuring or killing many people, who, unlike their European counterparts, do not have the government protecting them from drugs with no unique benefits, but significant, unique risks.
What you can do
Do not use Meridia or any other diet drugs. No diet drug has ever been shown to confer a health benefit in terms of reducing the serious complications associated with long-term obesity.
