Toronto, CanadaA lawsuit concerning the risk of Meridia side effects, which reportedly include a risk of Meridia heart attack and Meridia stroke, has been filed in Canada. The lawsuit was filed following a Meridia recall, announced after a clinical trial showed an increase in the risk of heart attack or stroke in patients who use the weight-loss drug.
The trial, published in the New England Journal of Medicine, was accompanied by an editorial calling for Meridia to be pulled from the market. The US Food and Drug Administration then pulled Meridia from the market, saying that the drug's risks did not outweigh "the very modest weight loss that people achieve" while taking Meridia. Specifically, the FDA noted that Meridia, known generically as sibutramine, "may pose unnecessary cardiovascular risks to patients."
According to the FDA's news release, a trial called Sibutramine Cardiovascular Outcomes (SCOUT), showed a 16 percent increase in the 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." Furthermore, the FDA notes that after the five-year trial was completed, participants who took Meridia lost only 2.5 percent more body weight than those who were given a placebo.
The FDA decided to pull Meridia from the market following approval of a Risk Evaluation and Mitigation Strategy (REMS) and a label change highlighting the risks of increased blood pressure and heart rate in patients who use the drug. The FDA, however, felt that there was not a defined population in which the benefit of Meridia clearly outweighed the risks of adverse events, and further felt that the REMS was not likely to mitigate those risks. As a result, Meridia was withdrawn from the market.
So far, no lawsuits have been filed in the US; however, some lawyers are now investigating the possibility of a lawsuit against Abbot Laboratories, maker of Meridia. Although litigation will likely not be as massive as litigation involving Fen-phen (another weight-loss drug pulled from the market due to an increased risk of heart problems), there is the potential for lawsuits to eventually be filed in the US.
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