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One of the controversial drugs, already included in the list of medicines “to avoid” by the French magazine Prescribe, but still used in Italy and reimbursed by our National Health Service, is Pioglitazone, known as Actos, for type 2 diabetes. Since 2011, France has withdrawn it and Germany has suspended reimbursement, due to the risk of cause bladder cancer. Since 2013 – and still today – Pioglitazone has been included among the “probable carcinogenic” substances on the IARC (International Agency for Research on Cancer) list. Two 2012 studies, in Canada and France, conclude that the risk of bladder cancer increases with the use of Actos, especially beyond 24 months of use. Meanwhile, in the United States, an employee of the Japanese company that produced it, Takeda, denounces the lies spread by the company that it knew about the cancer risks, keeping them hidden at the time of approval by the Food and Drug Administration. In 2014, Takeda was sentenced by the State of Louisiana to pay 2.4 billion dollars to diabetic patients for “intentional and reckless conduct” by failing to adequately warn of the potential risk of bladder cancer.
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Meanwhile, the European medicines agency, EMA, meets on various occasions, in 2011 and 2017, recognizing “a low risk of cancer” linked to Pioglitazone, but keeps it on the European market. In 2019, EMA’s CHMP Scientific Committee adds: “The data presented during the current reference period did not provide new information that would allow these risks to be reduced, mitigated or further characterized.” However, various European countries are taking precautions. The Dutch agency Zorginstituut writes on its website: “Treatment with Pioglitazone is not preferable. Its use may be associated with an increased risk of fractures and it is uncertain whether serious side effects such as bladder cancer, heart failure and pneumonia will occur.” The Dutch agency indicates the alternatives that exist today to treat type 2 diabetes.
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In Italy, according to the Association of Diabetes Doctors (AMD), 19,500 people took Pioglitazone in 2022. If instead we take the report of family doctors (Arno), the number rises to 34,000 (2019). The president of AMD, Riccardo Candido defends Pioglitazone, “an excellent drug because it acts as a stimulating insulin” and contests the studies on the incidence of cancer because they did not take other patient pathologies into account, such as smoking. The company that produces it today, the German Cheplapharm insists that “healthcare professionals are adequately informed about the use of Pioglitazone and should not use it in patients with active bladder cancer”.
Debora, a Tuscan patient who wishes to remain anonymous, however was told nothing a few months ago, when a diabetology luminary prescribed her Actos, as the drug needed to keep her diabetes at bay. “The doctor didn’t tell me about the risks of cancer or cardiovascular disease, I found this information on my own on the internet. He nor he told me of equally positive, but less dangerous alternatives. I’ll take it, but I’m scared.”
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