French and German Governments Suspend Use of Actos

Fri, 16 Dec 2011 11:34:20 +0100

An interim review of an ongoing epidemiological study by the FDA states that patients who have taken the diabetes drug Actos for more than a year may have an increased risk of bladder cancer.The warning comes just days after two European countries banned use of the drug. The European Medicines Agency (EMA) has yet to release any guidance on use of Actos. Five-year data show that although there's no overall increased risk of bladder cancer, patients with the longest exposure to and the highest cumulative dose of the drug were at greater risk, the agency said.

Just recently on June 10, 2011, the French Medicines Agency (FMA) suspended the use of pioglitazone-containing medications such as Actos.The decision by the French authorities was based on the results of a French retrospective cohort study, which became available on June 9, 2011. The German Federal Institute for Drugs and Medical Devices followed suit and advised physicians to stop prescribing the type 2 diabetes drug Actos to their patients based upon the French data.

The FMA refer their decision on a study which was conducted by the French Health Insurance Agency, examined cancer rates in some 155,000 diabetics taking Actos in France from 2006 to 2009 and 1.3 million other patients who were not receiving the agent. The scientists who were on the study found an adjusted hazard ratio of 1.22 (95% CI 1.05 to 1.43) for bladder cancer among those on Actos.

Based on these events the FDA has recommended to:

· Not use Actos in patients with active bladder cancer.
· Use Actos with caution in patients with a prior history of bladder cancer.

Actos is supposed help fight the symptoms and complications of type 2 diabetes.However, recent studies by the French Health Insurance Agency have shown that the drug can potentially cause Actos bladder cancer. If you are currently taking Actos for your type 2 diabetes consult your doctor as soon as possible if you are showing symptoms of side effects.

URL References:
fda.gov/Drugs/DrugSafety/ucm259150.htm
brakel2.hubpages.com/hub/Actos-and-Bladder-Cancer

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French and German Governments Suspend Use of Actos