October 2010 Archives

October 13, 2010

FDA Recalls Diet Drug Meridia

Drawing similarities to the now infamous drug, Fen Phen, the FDA recently recommended the recall of another weight loss drug, Meridia. Abbott Labs, the manufacturer of Meridia, followed through, withdrawing it on October 8, 2010. This decision comes after last month's split vote of an FDA panel over whether to withdraw the drug or add a black box warning to its label.

A medical study which showed an increased risk of strokes and heart attacks in people with heart disease prompted the FDA's recommendation to recall Meridia. The study, called the Sibutramine Cardiovascular Outcomes Trial (SCOUT), revealed that patients who took Meridia, also known as Sibutramine, had a 16% higher chance of heart attack and stroke than patients who took a placebo.

Meridia was approved by the FDA in 1997 and before the recall, was being used by about 100,000 people in the United States. Some of its side effects include chest pain, lightheadedness, irregular heartbeat and nausea. On January 21, 2010, the FDA alerted doctors and patients about Meridia's updated label information, in which Abbott agreed to include a new contraindication that it should not be taken by people with a history of cardiovascular problems including congestive heart failure, arrhythmias, and coronary artery disease. Other warnings included Meridia's link to cardiac valve dysfunction and primary pulmonary hypertension (PPH). The FDA advises that doctors stop prescribing Meridia, and patients cease taking this drug and ask their doctors for a different weight loss plan.

Continue reading "FDA Recalls Diet Drug Meridia" »

Bookmark and Share