Categorized | Fitness and Health

Actos Recall

Posted on 22 February 2012


Actos (pioglitazone), the type 2 diabetes drug, has been in the news recently for all the wrong reasons. Government agencies in the United States and in European countries are carrying out independent epidemiological studies on the effects of Actos after the drug was linked to bladder cancer.

Meanwhile, there has been a lot of rumors doing the rounds in the various media and the one that has probably hogged the most limelight is news of an Actos recall.

To date, there is no Actos recall. The drug is very much on the store shelves and physicians are still prescribing it to type 2 diabetes patients (although with warnings and precise precautions). Those warnings surround the link to longer use of Actos and bladder cancer and to heart conditions. Studies show a 40-percent increased level of bladder cancer for patients taking Actos

Those warnings no doubt fed the recall rumors, as did safety alerts issued by the U.S. Food and Drug Administration (FDA) in June of 2011 and the black box warnings that have come into effect since. But the FDA did not take the difficult step of mandating a recall, and drug maker Takeda Pharmaceuticals has not recalled Actos.

German and French regulators mandated Actos be taken off the market in those countries. They also mandated doctors in those countries stop prescribing the drug.

Actos Warning, Possible Recall?

However, the FDA is in the midst of carrying out a 10-year epidemiological study into the long-term effects of Actos. Although the study is far from being over, the FDA has published an ongoing safety review in September of 2010 based on a five-year interim analysis. According to this report, there are increased risks of bladder cancer in users who have had the longest exposure to the drug or have taken it in the highest cumulative dose.

Based on these findings, the FDA asked Takeda to effect a label change. The new Actos label carries statutory health warnings that inform users of the possible risks of bladder cancer resulting from a prolonged use or abuse of the drug. The company’s website promoting Actos also carries warnings about the drug’s dangerous side effects for heart conditions.

Physicians also were warned against prescribing Actos to patients suffering from bladder cancer and those who have a history of the ailment.

For some people, this drug is worse than the health condition that they are dealing with and for others it seems to have added to their woes.

Other European countries like France and Germany too have carried out their own studies and based on some disturbing findings, have banned the use of the drug.

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