Abbott Labs Recalls Weight Loss Drug Meridia
Abbott Laboratories have removed the weight less drug Meridia (Sibutramine) from the market due to increased risk of cardiovascular disease.
The weight loss drug has been removed from the United States market by its manufacturer, Abbott Laboratories. The company’s decision comes as a result of a request by the Food and Drug Administration (FDA) authority.
The FDA reviewed the results of Abbott Laboratories’ clincial trial of Sibutramine, the Sibutramine Cardiovascular Outcomes Study (SCOUT) and determined that the drug posed a significant risk of an adverse cardiovascular event occuring in patients. This study was a wide ranging double blind trial taking place in Europe, Latin America and Australia and involved 10,000 overweight/obese people with a history of cardiovascular events. The SCOUT results found that patients taking Sibutramine had a 16% increased risk of experiencing a negative cardiovascular event such as a non-fatal heart attack, non-fatal stroke or resusciation after cardiac arrest. For patients taking the drug, the study found that over a five year period, only a small amount of weight loss occurred compared to patients taking a placebo.
Sibutramine was approved by the FDA for use in obese patients, classified as patients with a BMI of more than 30 kg/m2 and additionally for patients with a BMI of 27 kg/m2 who have caridovascular risks. It is intended that the drug is used in combination with a low calorie diet.
In a press release, Abbott Laboratories said that the SCOUT results are an anomaly and 46 controlled clinical trials of sibutramine and over 6 million years of patient use history throughout its 13 year period in the market have not shown the same cardiovascular risk results of taking the drug. The company believes that the risk/benefit levels of the drug are positive and that it should be allowed in the marketplace.
At this stage, the withdrawal of Sibutramine affects the European and U.S. markets only. The FDA advises that patients currently taking Sibutramine (Meridia) should stop taking the drug and discuss alternative options with their health care professionals.
Source: Tracey Lloyd, DigitalJournal.com
