Abbott Agrees to Voluntary Recall of Meridia at Request of FDA
On October 8, 2010, drug giant Abbott announced it had agreed with an FDA request to voluntarily remove the diet pill Meridia (sibutramine) from the U.S. market after data from the Sibutramine Cardiovascular Outcomes (SCOUT) clinical trial showed Meridia users had an increased risk of heart attack or stroke. The six-year clinical trial data revealed patients who took Meridia had a 16% increase in risk of major adverse cardiovascular events (a composite of non-fatal heart attack, non-fatal stroke, resuscitation after cardiac arrest and cardiovascular death) in patients treated with Meridia compared to patients taking a placebo. At the end of the trial (60 months) patients who took Meridia only lost 2.5% more weight than patients taking placebo. After examining the data, the FDA concluded that the risk for an adverse cardiovascular event from Meridia outweighed any benefit from the modest weight loss observed with the drug.
Meridia was approved by the FDA in 1997 for weight loss and maintenance of weight loss in obese people. Approximately 1.3 million prescriptions were written for Meridia in 1998 and the drug was initially considered a success. Currently, it is estimated that approximately 100,000 patients use Meridia. The FDA issued a simple warning to those patients: stop taking it, and consult your doctor about a new weight loss plan.
