A call to pull risky diet pill

Abbott Laboratories' weight-loss pill, Meridia, is arranged for an illustration... — Abbott Laboratories' weight-loss pill, Meridia, is arranged for an illustration at Skenderian Apothecary in Cambridge, Massachusetts on Friday, January 5, 2006. Weight-loss treatments need more study to prove they also help people live longer before doctors can be sure the benefits are greater than the risks and that the high cost is justified, researchers said in today's Lancet. While drugs such as Roche Holding AG's Xenical and Abbott Laboratories' Meridia have proven to help patients lose weight, tests that show treatments save lives or cut deadly risks such as heart disease should be required, Raj Padwal and Sumit Majumdarof the University of Alberta Hospital in Edmonton said in the journal. Photographer: JB Reed/Bloomberg News. Credit: BLOOMBERG/JB REED

By SHARI ROAN. Los Angeles TimesSeptember 1, 2010

LOS ANGELES - The prescription diet drug sibutramine, sold under the brand name Meridia, should be taken off the market because it raises the risk of heart attacks and strokes in some patients, the editor of the New England Journal of Medicine said yesterday.

Those risks, published in January on a government clinical trials website and now in full in the journal, outweigh the modest benefits of the medication, said Dr. Gregory D. Curfman, the journal's executive editor and lead author of an editorial that accompanied the study.

The preliminary results published on the government website showed that sibutramine increased the rates of nonfatal heart attacks and strokes in people who had a history of cardiovascular disease and took the medication for an average of 3.4 years. Based on those data, the drug was withdrawn in Europe earlier this year. The U.S. Food and Drug Administration will hold hearings later this month to reconsider the drug's safety.

If the medication is pulled, that would leave Xenical as the only prescription weight-loss medication on the U.S. market other than from stimulant medications that are intended only for short-term use.

"Sibutramine doesn't help people," Curfman said. "It doesn't result in very much weight loss, and it doesn't improve their clinical condition. On the other side, it carries these risks."

Sibutramine was approved in 1997, but its sales have been modest. The medication works by altering levels of key chemicals in the brain to decrease appetite. It is known to increase blood pressure and heart rate, and the drug is labeled with a warning that it should not be used in patients with heart disease and should not be taken for more than two years.

After the drug's approval, manufacturer Abbott Laboratories was asked by European regulators to conduct research on the drug in people with a history of cardiovascular disease, diabetes or both. The randomized study, of 9,804 overweight or obese people, found that the risk of a stroke, heart attack, cardiac arrest or cardiac death was 16 percent higher among people taking sibutramine compared with those taking a placebo, according to the report to be published today.

Overall, nonfatal heart attacks occurred in 4.1 percent of sibutramine users and 3.2 percent of the placebo group, and nonfatal strokes occurred in 2.6 percent of sibutramine users and 1.9 percent of the placebo group.

Streaming Now