FDA Warns of Heart Risk for Meridia

Posted on Feb 1, 2010 in Uncategorized

Weight Loss Drug Called Risky for People With Hypertension or Heart Disease

By Daniel J. DeNoon

WebMD Health NewsReviewed by Brunilda Nazario, MDJan. 21, 2010 – The weight loss drug Meridia is too dangerous for people with high blood pressure or heart problems, the FDA today warned.

European authorities today went one step further and banned the drug, known generically as sibutramine and sold in Europe as Reductil.

“Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweighs the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment,” the U.K.’s Medical Healthcare Products Regulatory Agency (MHRA) says in a news release.

The FDA based its warning on new data showing a higher-than-expected risk of heart attack and stroke. The FDA says Meridia should NOT be taken by people with:

A history of heart attack or angina (coronary artery disease)

A history of stroke or transient ischemic attack (TIA, sometimes called a “mini-stroke”)

A history of any kind of irregular heartbeat (for example, atrial fibrillation or brachycardia)

A history of heart failure

A history of peripheral artery disease

Uncontrolled high blood pressure

“Patients currently using sibutramine should talk with their health-care professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment,” the FDA recommends.

The FDA approved Meridia in 1997 for certain groups of patients at risk of weight-related health problems.

While the FDA has not withdrawn its approval, the MHRA and the European Medicines Agency have.

“Pharmacists are asked to cease dispensing the medicine,” the MHRA declares. “People who are currently taking Reductil [Meridia] are advised to make a routine appointment with their doctor to discuss alternative measures to lose weight. There are no health implications if people wish to stop treatment before seeing their doctor.”