FDA Declines To Ban Diet Drug

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.

But cardiovascular disease is common among the obese, Galson cautioned.

There's no way to tell from these vague reports whether Meridia — known chemically as sibutramine — actually increased that risk, while earlier studies suggested it didn't, he concluded.

A study is under way that may settle the question, he wrote. It is tracking the heart health of 9,000 obese Europeans at particularly high risk for cardiovascular disease because of a previous heart attack or other problem. Half are taking Meridia, the other half a dummy drug. Independent safety monitors are checking the data monthly.

"FDA will be immediately notified and will take appropriate regulatory action if any serious safety concerns are identified," Galson wrote.

Abbott welcomed FDA's decision, saying about 15 million patients in more than 75 countries have used Meridia since it hit the market in 1997. But the company said it followed Galson's order to beef up warnings that Meridia is not for everyone.

Those warnings say Meridia substantially increases blood pressure or heart rate in some patients and should not be given to anyone with poorly controlled hypertension, a history of heart disease, stroke or severe liver or kidney disease, or by pregnant or breast-feeding women.

A controlled substance because it works by affecting brain chemicals, Meridia is intended for people who need to lose 30 pounds or more.

Public Citizen's Dr. Sidney Wolfe blasted FDA's ruling as "dangerously flawed," comparing it to the agency's earlier decisions to keep on the market other drugs, such as the painkiller Vioxx, later deemed too risky.