NEJM fuels calls to withdraw Abbott's Meridia

Get ready for more controversy over Abbott Laboratories' (NYSE: ABT) diet pill Meridia. Two weeks before an FDA advisory panel meets to consider the drug's safety, final data from a long-term, 10,000-patient study has hit the New England Journal of Medicine. And while the authors of the Abbott-funded study say the data show nothing new about Meridia's risks, NEJM's editors have called for the drug to be yanked from the market.

The study found that Meridia increases the risk of heart attack and other cardiac problems and isn't particularly effective at spurring weight loss. Patients on Meridia lost nine pounds, on average, compared with four pounds among placebo patients. Furthermore, those taking Meridia had a 28 percent higher risk for nonfatal heart attack and a 36 percent increased risk for nonfatal stroke, compared with those taking placebo, the authors found.

The study authors--and Abbott itself--say that the Meridia patients who suffered heart attacks and strokes had pre-existing heart trouble and, as such, shouldn't have been taking the medicine at all. In January, Meridia got a new warning against use in patients with heart problems.

Should the FDA pull Meridia off the market partly because doctors misprescribe it? Some experts say yes; others say no. NEJM's leadership  thinks so. Dr. Greg Curfman, executive editor, tells HealthDay that the SCOUT trial data shows that the risks of Meridia outweigh its benefits; its weight-loss results were "very unimpressive," he says, adding, "[W]e don't see a rationale for keeping this on the market." And Sid Wolfe of Public Citizen, which has petitioned the FDA for Meridia's withdrawal, tells Reuters that the agency "has unconscionably allowed this drug, which should not have been approved in the first place, to stay on the market."

- check out the study abstract
- get the NEJM editorial (purchase required)
- see the HealthDay story
- get more from the NYT 
- check out the Reuters coverage

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