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FDA Approves Actos Generic Version

When the FDA released its own study that showed Actos can increase the risk of bladder cancer, it caused two foreign governments – France and Germany – to ban the drug outright, but it has never left the shelf in the U.S., where it is now being unleashed in generic form.

The Food and Drug Administration has approved the first generic version of the type 2 diabetes drug Actos, which will make the popular and controversial drug available at a lower price, hence likely to be taken by more and more diabetics. Mylan Pharmaceuticals will manufacture the first generic form of Actos in 15-, 30-, and 45-milligram doses.

Actos Lawsuits & Generic Accountability

The approval of pioglitazone hydrochloride (marketed by Takeda Pharmaceuticals as Actos) comes as the brand-name manufacturer is facing increased litigation over the drug’s link to bladder cancer.  Hundreds of lawsuits have been filed against the brand-name manufacturer; but if anyone who takes the generic version suffers a heart attack, that person will probably be less likely to be able to enlist a lawyer to file a lawsuit, given last summer’s 5-4 vote by the Supreme Court to essentially insulate generic drug makers from liability in tort suits.

Science & History

Actos regulates blood sugar levels. It belongs to a class of drugs known as thiazolidinediones (TZDs), a class marred by two previous diabetes medications that have either been pulled from the market (Rezulin) or severely restricted (Avandia) because of links to life-threatening “side effects.”

Black Boxed Warnings

As it approves a generic formulation of Actos, the FDA is also reissuing the safety guidelines for prescribing the drug, as many people will likely find the lowered price attractive. The agency notes the drug’s common side effects: upper respiratory tract infection, headache, muscle pain, sore throat, and sinus infection. It also lists the Black Box warnings with which the drug has been labeled since its initial approval – such as a link to heart failure, bone fractures, and liver disease.

Long-term Use Problems

Actos use has risen recently in the absence of a competitive TZD drug like Avandia, so more attention has been given to the drug’s link to life-threatening bladder cancer. The FDA warned last year that long-term or high-dosage use of Actos in the treatment of Type 2 diabetes could greatly increase a person’s risk of developing bladder cancer. Taking Actos for as long as five years could create a two- or three-fold increased risk of bladder cancer.  Some people have also developed cancer after taking Actos for less than a year at high doses. Elderly men over 60 are most at risk of developing bladder cancer while taking Actos, according to recent studies.

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