To date, the FDA has issued numerous Avandia warnings. The first Avandia warning was issued in February 2007, when the FDA announced that Avandia increases the risk of bone fractures, particularly in women. A few months later, in June 2007, the New England Journal of Medicine published an article warning that Avandia can increase the risk of heart attack by as much as 43 percent and the risk of death from heart-related problems by 64 percent.
In response to the New England Journal of Medicine article, the FDA issued a safety warning stating that Avandia patients with a history of heart disease, heart attacks, or strokes may be at an increased risk of suffering a heart attack or heart-related death. Then, on June 7, 2007, the FDA ordered that the Avandia label include a “black box warning, which is the strongest warning a drug label can carry.
The initial Avandia black box warning indicated that Avandia may cause serious, life-threatening side effects. In addition, the warning stated that Avandia patients should be closely monitored by their physicians. In November 2007, the Avandia warning label was updated by GlaxoSmithKline with a warning that the available data on the heart risks associated with Avandia are inconclusive and not confirmed. The Avandia warning label was also updated with a warning that Avandia is not recommended for patients using insulin or nitrates.
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Avandia Recall
Despite warnings about Avandia’s life-threatening side effects, no recall has been issued for it yet. Still, many physicians and patients believe that the FDA should take action and issue an Avandia recall. To them, Avandia’s black box warning is simply not enough to protect Avandia patients from the drug’s dangerous side effects.
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If you or a loved one took a diabetes medication, such as Avandia, and suffered from heart complications, bone fracture, or any other serious injury associated with Avandia, please contact us today to learn more about your legal options as you may be entitled to compensation.
