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Regulators probe diet drug safety after study
More diet pill news today, and it's not encouraging. European regulators say Abbott Laboratories' Meridia drug should be suspended because of associated risks of stroke and heart attack. The EMEA cited a study of 10,000 patients that suggested taking Meridia--sold in Europe under the brand names Reductil, Reduxade, Zelia, et al.,--put them at a higher risk for heart disease, Dow Jones reports.
"[T]he risks of these medicines are greater than their benefits," the EMEA says in a statement. That assessment will now go to the European Commission for review. If the E.C. agrees, then these diet drugs may indeed be pulled off the European market.
In the U.S., the FDA says it will convene an advisory committee to consider the new data. A date for that confab will be set after the agency receives Abbott's report on the study, which is expected in March. Until then, Meridia patients should ask their doctors whether to continue using the medicine, the FDA says.
The U.S. agency also is adding a contraindication to Meridia's label, stating that the drug shouldn't be used in people with heart disease. EMEA goes farther, saying that doctors shouldn't prescribe the meds pending an E.C. decision.
- check out Abbott's announcement
- see the EMEA statement (.pdf)
- get the statement from FDA
- read the Dow Jones news
- check out the post at the WSJ Health Blog
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