New data suggests that the widely used diabetes drug Avandia may significantly increase the risk of heart attack and heart-related deaths, according to a safety alert issued yesterday by the Food and Drug Administration.
The agency is encouraging patients, especially those with a history of heart disease or those at high risk of heart attack, to consult with their physician and weigh the options for their diabetes treatment.
Since its approval in 1999 for the treatment of type 2 diabetes, Avandia has been linked to various heart-related adverse events including congestive heart failure, edema and fluid retention. The drugs labeling has been updated several times, most recently in 2006, to include warnings about the increased heart risks in some patients.
The analysis that prompted the safety alert suggests that Avandia may increase a patients risk heart attack and other cardiovascular event by as much as 30 to 40 percent. Data analyses are ongoing, but if this new data is confirmed, the implications could be devastating for the numerous patients taking the drug.
(Source: http://www.fda.gov/)
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