WebMD Health News
Daniel J. DeNoon
Laura J. Martin, MD
Oct. 8, 2010 -- At the FDA's request, Abbott Laboratories is withdrawing the weight loss drugMeridia from the market.
The FDA says the drug, approved in 1997, raises the risk of heart attack and stroke but offers little benefit.
In September, an FDA expert advisory panel split in an 8-8 vote over whether the drug should be allowed to stay on the market.
"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," said John Jenkins, MD, director of FDA's drug evaluation branch.
The estimated 100,000 U.S. patients taking Meridia are advised to discard any remaining pills in their possession and to consult their doctors about alternative weight loss plans.
Abbott strongly disagrees with the FDA's evaluation of Meridia but says it will comply with the federal agency's request.
"Abbott believes [Meridia] has a positive risk/benefit profile in the approved patient population, but will comply with the FDA's request," the company says in a news release.
Concerns about Meridia risks were raised at the time the drug was considered for approval. At that time, the drug was shown to increase heart rate and blood pressure. But since weight loss was supposed to reduce this risk, it was thought that the drug's benefit would more than make up for the risk.
However, European drug regulators insisted that Abbott carry out a postmarketing clinical trial to evaluate heart risk. The trial, called SCOUT, enrolled overweight and obese patients with risk factors for serious heart disease. Most of these patients would not be prescribed Meridia in the U.S. But Abbott expected the study to show that even these patients benefited from the drug.
Instead, Meridia slightly increased the SCOUT patients' risk of heart attack and stroke.
"The fact that it showed no benefit but actually harm was important new information," Jenkins said at a news teleconference. "When we started reviewing that data, we realized that all patients using this drug are at risk of those events, even though the risk in any individual patient might be very small."
Here's the FDA's full advice to patients now taking Meridia:
Unapproved drugs, often sold as supplements, are frequently found to contain various amounts of sibutramine, the active ingredient in Meridia.
Coincidentally, the FDA today warned that a "supplement" called Slimming Beauty Bitter Orange Slimming Capsules contains dangerous amounts of sibutramine. The product is sold over the Internet by Beautiful Health Inc., formerly LL Health and Beauty.
The label falsely says the product is "100% herbal." The mislabeled drug was distributed in Chicago at the Mexican Independence Day parade and may be distributed at other community events.
People taking the pills can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure. It may be very dangerous to people with underlying heart conditions.
SOURCES:FDA news release.Abbott news release.FDA web site.FDA news teleconference, Oct. 8, 2010.
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