November 14, 2007: Heart Attack Risk Added to Avandia Labeling
Labeling on the diabetes drug Avandia will now carry a boxed warning of increased heart attack risk, according to an Announcement from the U.S. Food and Drug Administration (FDA). The warnings will state that studies "have not confirmed or excluded" the risk of heart attack and chest pain associated with Avandia use, because data evaluated by the FDA shows that "there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments."
September 12, 2007: JAMA Studies Show Avandia Heart Risk
Two studies published in the Journal of the American Medical Association (JAMA) on September 12, 2007 found that use of Avandia (rosiglitazone) greatly increased the risk of heart attack and heart failure, and suggested that safer diabetes medications are available. See the JAMA Study on Avandia (rosiglitazone).
August 14, 2007: Avandia to Carry "Black Box" Warning
The U.S. Food and Drug Administration (FDA) announced that a number of diabetes drugs -- including Avandia (rosiglitazone) -- would now carry "black box" warnings on the risk of heart failure associated with use of the drugs. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients. The "black box" warning is FDA's strongest form of warning. FDA's review of Avandia and possible increased risk of heart attacks is ongoing. (Read the FDA Announcement)
July 30, 2007: Panel Makes Recommendations on Avandia
An FDA advisory committee recommended that diabetes medication Avandia (rosiglitazone) remain on the market despite evidence that use of the drug increases the risk of heart attacks. The panel advised the FDA that Avandia labeling should carry warnings of the increased risk of heart attack associated with the drug's use.
May 21, 2007: FDA Safety Alert on Avandia
The U.S. Food and Drug Administration (FDA) issued a safety alert on the diabetes drug Avandia (rosiglitazone), and its links to heart risks. The alert was issued shortly after a study published in the New England Journal of Medicine (NEJM) suggested a connection between use of Avandia and an increased risk of heart disease and heart attack. The NEJM article concluded that "patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone [Avandia] for type 2 diabetes." (Read the FDA Safety Alert)
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