Monday, October 11, 2010
Diet Drug Meridia Pulled from US Market
WASHINGTON, DC – Under strong pressure from the Food and Drug Administration (FDA), pharmaceutical manufacturer Abbott Laboratories submitted to a voluntary recall of its weight-loss drug Meridia. The FDA's John Jenkins, M.D., said in a firm statement Friday that "Meridia's continued availability is not justified," given the minimal weight-loss benefits of the drug and the increased risk of heart attack and stroke.
The FDA has advised the approximately 100,000 US patients taking Meridia to stop using the diet drug and speak to their doctors. The decision by the FDA to ask for a drug recall of Meridia resulted from clinical trial results published in late 2009.
In this study of more than ten thousand patients, 11.4% of patients taking Meridia suffered a heart attack, stroke, or serious cardiac event. Only 10% of patient taking a placebo suffered these events. Statistically, this represents a 16% increase in the relative risk of a heart attack, stroke, or cardiac problem for Meridia users. In addition, the trial found that Meridia only increased weight loss by about 2.5% of body weight compared to placebo, a modest result at best.
Abbot disputes the results of this trial, which was done at the request of European regulators, who subsequently removed Meridia from the European market in January of this year. While only half of the members of an FDA committee on September 15th recommended a defective drug recall, the FDA decided Friday to withdraw Meridia because "there was no identifiable population of patients for whom the benefits of Meridia outweighed its risks."
Meridia is not the first weight-loss drug to be recalled for safety concerns as it is preceded by recalls of Phen-Phen and Hydroxycut®.
While the FDA recall of Meridia is will probably not have a severe impact on Abbott's profitability, it will certainly increase the pharmaceutical company's vulnerability to prescription drug injury lawsuits by raising awareness of Meridia's dangers and lending legitimacy to Meridia pharmaceutical injury lawsuits.
As experienced pharmaceutical injury lawyers, we at Schlichter, Bogard & Denton expect an increase in Meridia heart attack lawsuits just as the recall of Avandia has sparked an increase in Avandia heart attack lawsuits.
If you or a loved one has suffered a heart attack, stroke, or serious cardiac problem after taking Meridia, please contact the pharmaceutical injury attorneys of Schlichter, Bogard & Denton today for a complimentary case evaluation.
posted by
Nathan Graber
at
4:52 PM

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