Consumer advocacy group petitions FDA to ban Meridia over increased heart risks.

The AP (12/4) reports, "A consumer advocacy group is petitioning the government to ban the weight loss pill Meridia [sibutramine] because a recent study suggests it increases the risk of heart attack, stroke, and death." In a letter to the FDA, Public Citizen calls on the agency "to pull Abbott Laboratories' drug from the US market," citing results from "a 10,000-patient study" that "showed a slightly higher risk of heart-related problems in patients taking Meridia...compared with a dummy pill." But, the FDA "said it was 'making no conclusions about the preliminary findings' when they were released last month." The agency "previously rejected a 2002 petition from Public Citizen to withdraw Meridia," saying "it wanted to wait for the findings of the 10,000-patient study."

According to Reuters (12/3, Richwine), a spokesman for Abbott noted that some participants in the recent study took the drug for longer than approved. The data, therefore, do not require a change in the drug's safety profile, he added.

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