FDA Approves Generic Actos Despite Bladder Cancer Risk
August 17th, 2012 tmccoy
Mylan Pharmaceuticals was given approval by the FDA to produce and sell the first generic version of pioglitazone (Actos) to treat type 2 diabetes. The company will be allowed to sell 15, 30 and 45 mg tablets of the drug. The box for the generic drug will have the same black box warning about heart failure and the increased risk of bladder cancer if taken for over one year.
The FDA first announced a warning about Actos and bladder cancer last year after the results of an epidemiological study found that people taking Actos for the longest time and at the highest dosage were at the highest risk for bladder cancer. France and Germany had banned the drug just a few days before the FDA made this announcement.
Two more recent studies have confirmed the linkage between Actos and an increased risk for bladder cancer. Some other studies say that bladder cancer may just be a class effect of a drug family called thizolidinediones (TZDs).
Avandia is another TZD that was in the news because of the serious side effect that it caused. In 2010, Avandia (rosigiliazone) usage was strongly curtained in the US after it was linked to an increased risk of heart attack.
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