Abbott Labs recalls diet drug Meridia due to heart attack risk, ineffectiveness
"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, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, in a statement. "Physicians are advised to stop prescribing Meridia to their patients, pharmacists are advised to stop dispensing [it] and patients should stop taking this medication and dispose of any remaining products."
Meridia contains the active ingredient sibutramine, a prescription-only stimulant which may lead to elevated blood pressure, stroke and heart attack, especially in people with a history of cardiovascular disease. The drug was approved by the FDA in 1997 for weight loss and maintenance of weight loss in obese people. Its approval was based on studies that showed more people taking it lost at least 5% of their body weight than people on placebo who relied on diet and exercise alone.
About 100,000 people are currently taking Meridia, the FDA said during the conference call with reporters.
The agency today also advised consumers to stop using Slimming Beauty Bitter Orange Slimming Capsules, an over-the-counter diet supplement which also contains sibutramine. It is falsely labeled "100% Herbal" and claims it is a natural calcium and vitamin capsule safe for use in children as young as two years old, according to regulators. The pills are sold over the Internet by Beautiful Health, Inc.
FDA lab tests revealed that even consumers who are otherwise healthy but who take the amount of sibutramine found in Slimming Beauty are likely to experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and high blood pressure. The controlled substance may also interact with other medications and cause serious side effects.
The agency reported that sample packets of Slimming Beauty were distributed at community events, including the 40th Annual Mexican Independence Day Parade in Chicago last month. Several reports of adverse side effects have been filed.
Earlier this year regulators found that Alli, the over-the-counter weight loss blockbuster drug, and its prescription-only equivalent Xenical may cause potentially fatal liver damage.
Diet pills account for a large portion of the weight loss market in the U.S., expected to be worth $310 billion by 2014, with an annual growth rate of 12.2%, according to a new report by research consultancy MarketsandMarkets.