James T. Capretz Products Liability Law Blog on Lawyers.com

Actos & Avandia News

Tuesday, September 21, 2010 by James T. Capretz

On Friday September 17, 2010 the Food and Drug
Administration (FDA) announced that it is investigating the popular diabetes
medication Actos (Pioglitazone), which is a drug commonly used in the treatment
of patients with type 2 diabetes mellitus.

The announcement was made following the release of preliminary data showing thatthe drug may increase the risk of bladder cancer. According to the FDA, Takeda Pharmaceutical Company, the maker of Actos has been conducting a 10-year observational study designed to evaluate the risk of bladder cancer associated with Actos. Early
(5-year) results showed no overall association between Actos exposure and risk
of bladder cancer. Again, according to the FDA, there was an increased risk of
bladder cancer in patients with the longest exposure to Actos and in those with
the highest cumulative dose of the drug.

Actos is in the same class of drugs as GlaxoSmithKline’s Avandia (Rosiglitazone). Avandia has been in the spotlight recently because it allegedly increases the
risk of cardiovascular disease, heart attacks and stroke. In a study reported in
August 2010, a team led by Debra Wertz, an outcomes research manager at
HealthCore Inc., suggested that the cardiovascular risk is the same for both
Actos and Avandia.

The FDA said it will continue its investigation and will further inform the public in the upcoming months. It has not yet been determined if the drug in fact does
increase the risk of bladder cancer. The agency said that patients are not
advised to discontinue their use of Actos and should contact a healthcare
professional regarding any concerns they have about the drug.

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Posted at 20:36 PM

Topic: Products Liability