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FDA Declines To Ban Diet Drug

Meridia Diet Drug Obesity FDA
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The government won't ban the prescription diet drug Meridia but, faced with reports of deaths, says it will closely monitor a European study designed to better assess the pill's heart risks.

The consumer group Public Citizen had petitioned the Food and Drug Administration for a ban, citing Meridia users who died of heart problems as young as their 20s and 30s. Even before Meridia was approved for sale, the FDA knew it could increase users' blood pressure, the group contended.

The FDA denied Public Citizen's request for a ban in a ruling issued Aug. 9 but made public Wednesday by Meridia manufacturer Abbott Laboratories.

In that ruling, FDA drug chief Dr. Steven Galson acknowledged questions about Meridia's cardiovascular effects, and said the agency had ordered Abbott to take stronger steps to ensure that dieters with heart disease aren't prescribed the drug — and to stress the importance of monitoring users' blood pressure.

But Galson said a two-year review of Public Citizen's complaints concluded the benefits of modest weight loss from Meridia outweigh the drug's risks.

Public Citizen wasn't the only one to complain about Meridia. Whistleblower David Graham, an FDA drug safety officer, testified to Congress last fall that his agency was allowing five unsafe medicines to stay on the market, including Meridia.

Between 1997 and 2003, the FDA received reports of 30 Meridia users who died of cardiovascular problems and 224 other reports of nonfatal strokes, heart attacks and other cardiovascular ailments, Galson wrote.

He didn't say how many additional complaints FDA has received in the ensuing two years.