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January 14, 2017 – Is there an increased risk of bladder cancer with pioglitazone-containing medicines? Some (most) drug regulatory agencies worldwide do think so. However, the actions taken vary considerably. The example of the French ANSM (L’Agence nationale de sécurité du médicament et des produits de santé en France) is at one end of the possibilities of actions on could take. In 2011 already, based on the results of an extended epidemiological study (published in 2012) conducted in France which suggested an increased risk of bladder cancer with pioglitazone, the ANSM suspended the use of the pioglitazone-containing medicines (i.e., Actos and Competact) in France.
At the same time in 2011 when the American Food & Drug Administration (FDA) was also fully aware of this epidemiological study conducted in France, FDA resorted to a Safety Communication on June 15, 2011, which in fact was an update of an Safety Communication in 2010 on an “Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure” only. Similarly, at the same time the European Medicines Agency (EMA) was in the process of reviewing all available data on pioglitazone-containing medicines use and re-analyze the risk / benefit ratio shortly, while Germany’s Federal Institute for Drugs and Medical Devices (BfArM) at least recommended not to start pioglitazone-containing medicines in new patients. Consequently, in very big markets worldwide, patients remained on pioglitazone-containing medicines and the associated risk for bladder cancer.
And here we go again: On December 12, 2016, FDA has concluded in a Drug Safety Communication, referring to an updated FDA-review of data indicating that there exist an increased risk of bladder cancer with pioglitazone-containing medicines, which currently include, in the US Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni. The drug labels of these medicines already contain warnings about the risk of bladder cancer, and FDA has approved label updates to describe the additional studies reviewed.
The question remains if just analyzing data and adjusting drug labels by the FDA is sufficient to protect patients from the risks of getting bladder cancer. In the light of still additional and very serious adverse effects of, for example Actos, there arises the question if FDA should not simply ban pioglitazone-containing medicines and in doing so saving thousands of patients from suffering form bladder cancer. Bladder cancer definitively is no feat. Generally, protecting patients from unintended suffering brought about by medications should be at center stage not at FDA alone, but at all registration authorities worldwide. Whether that is really the case in context of pioglitazone is at least in doubt.
The fact that the manufacturer settles legal cases of patients (or their families) who have connected their bladder cancer condition with taking piaglitazone-containing medications for millions of dollars indicates that enormous economic interest are associated with these medicines. It it unlikely that the manufacturer pays these sums in favor of the individual patient who suffered and in acknowledgement of the sometimes fatal deficiencies of their product. Its seems more a measure to get the product out of sight of negative marketing and news.