FDA Approves Generic of Controversial Diabetes Control Drug

Actos®, the diabetes management drug that has helped those with type 2 diabetes for over a decade, has been approved by the FDA in a generic form. This is despite several countries banning the drug and the FDA putting the drug under an “ongoing safety review.”

Dr. Gregory Geba, director of the Office of Generic Drugs for the FDA says,

"Generic versions of this widely used product will offer affordable treatment options for patients who must manage this chronic and potentially serious condition."

The FDA asserts that the generic form is “of the same strength and quality” as the non-generic counterpart.

Approved Here, Banned Overseas

All drugs have side effects, and Actos, otherwise known by its chemical name pioglitazone HCL, is no exception. The list includes minor things, such as sinus infection, muscle pain, sore throat and headache, but they also include serious side effects, such as an increased risk of bladder cancer, heart failure, and liver disease. The FDA says in its report,

“The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.”

According to the consumer watchdog Drugwatch.com, Actos has already been recalled in Germany and France due to the increased bladder cancer risks. In a study done by the French Medicines Agency, patients using the drug have over a 20 percent higher incidence of bladder cancer than those taking alternative drugs.

While France’s medical regulators recalled the drug last year, the FDA is taking a “watch and see” approach to Actos. Approving the generic form of the drug may make it more widely available, which is a concern to Drugwatch.com, and others wanting the safest, most effective drugs for treating diabetes.

Sources


http://www.actos.com/
http://diabetes.webmd.com/news/20120817/fda-oks-generic-actos-for-type-2...
http://www.drugwatch.com/actos/recall.php
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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