[JessLess]

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Weight loss drug pulled from market
October 8th, 2010

Abbott Laboratories has agreed to take its obesity drug Meridia (sibutramine) off the market, the U.S. Food and Drug Administration announced Friday.

The company voluntarily withdrew the drug because clinical trial studies showed there was an increased risk of heart attacks and strokes in people who used the drug.

Approximately 8 million people worldwide take the drug, the FDA said, including 100,000 Americans.

The drug had projected sales of $30 million in the U.S. in 2010, Abbott said.

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," Dr. John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said in a conference call Friday. "Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs."

Approved in 1997 for weight loss, the original data on the drug showed that people who took Meridia lost at least 5 percent more of their body weight than people who were on a placebo and relied on diet and exercise alone.

The FDA requested the company withdraw the drug, after reviewing data from a follow-up study known as the Sibutramine Cardiovascular Outcomes Trial (SCOUT ). It showed there was a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, and death, in a group of patients given Meridia as opposed to others given a placebo.

"In all its investigation of the drug, the FDA could find not one person whose benefit from the drug outweighed its risk," said Dr. Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research.