Abbott Laboratories announced Friday, October 8, 2010, that it was withdrawing the diet drug Meridia from the market over concerns it significantly raises the risk of heart attacks, strokes, and other serious cardiac episodes. In addition to this, there are concerns about the actual weight loss benefits of Meridia. While Abbott has called this a voluntary recall, it is known that it was done so under pressure by the Food and Drug Administration.
If you or a loved one has suffered a heart attack, stroke or other serious side effect after taking Meridia, please email or call our experienced Florida pharmaceutical injury lawyers today.
Meridia, also known as sibutramine, was approved by the FDA in 1997 as a prescription only weight loss pill for obese patients who may have other risk factors, such as diabetes, high blood pressure, and high cholesterol. Meridia has been under an FDA safety review for almost a year. There was a split decision made by an FDA advisory committee in September over whether the weight loss drug should be withdrawn or not over concerns it was a dangerous drug. It was withdrawn from the European market in January 2010.
Abbott Laboratories asked the FDA advisory panel to use warnings and restrict the sales of the drug rather than banning it outright. However, the company does not promote the drug and its sales amounted to only $30 million last year.
In 2002, there was a petition to ban sibutramine after the FDA received 29 reports of patient deaths. Nineteen of the 29 deaths were due to cardiovascular events like heart attacks. Ten of these deaths involved people 50 years or younger, and three of them involved women under the age of 30. Over 140 additional patients reported heart arrhythmia. However, the drug was not pulled from the market.
Meridia Clinical Trial Results
A clinical trial of the drug’s results that involved 10,000 people was announced late last year. It was found that of the patients who took Meridia, over 11 percent of them suffered a heart attack, stroke, or other serious cardiac problem compared with ten percent of those who were given a placebo. The FDA states this is a 16 percent increase in the relative risk of Meridia. In addition to these findings, European regulators found that patients taking the drug only lost 2.5 percent more weight than those who were taking the placebo.
Abbott has taken issue with the results of the clinical trial, but still agreed to remove the drug from the market.
The FDA has stated that Meridia patients should immediately stop taking the drug and consult with their physician.
If you or a loved one has suffered a heart attack, stroke, or other cardiac event you believe is associated with Meridia, please contact the experienced Florida pharmaceutical litigation attorneys at Colling Gilbert Wright for an initial case consultation.