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Posts Tagged ‘clinical trial’

Clinical Trials Demonstrate Increased Risks Associated with Meridia

by admin on: November 30th, 2011

A clinical trial sponsored but Abbot Laboratories, the makers of the diet pill Meridia, reported in September 2010 that using Meridia resulted in an increased risk for heart attacks and stroke. Additionally, in 10,000 overweight or obese patients, there was little evidence to show that the patients experienced the positive effects of Meridia ??? namely a slimmer waist (average loss of weight was 9 pounds over a period of about 3.5 years).

Three of the authors of this study, which was published in theNew England Journal of Medicinein, concluded that, based on their results, Meridia should not be prescribed to patients that have pre-existing heart problems ??? a precaution already noted on the drug label. In a somewhat unusual response, the editors of the journal wrote an editorial that Meridia (also known as Sibutramine) should be pulled from the market.

In January 2010, the European Medicines Agency saw the preliminary data from this study and ordered Abbot Laboratories to remove Meridia from the European market. The U.S. Food and Drug Administration (FDA) issued a warning on November 20, 2009 and, after the conclusion of this study, is set to convene a panel to further evaluate whether Meridia should be pulled from U.S. markets.

One potential reason that the Meridia is still allowed to be marketed in the United States is that the officials that were responsible for approving the drug originally are the same ones that are in charge of the continued assessment of this drug. One official with the FDA commented there should be separate offices that handle approvals and re-assessments.

Of course, there are others, such as the lead author of the Meridia study, that suggests Meridia is beneficial for obese patients that do not have heart conditions. The difference, it seems, depends on how one approaches the data ??? one can look at the general population or an individual patient.