Diabetes drug increases bladder cancer risk

Suspected cancer: authorities withdraw diabetes drug approval

10/06/2011

After the diabetes drug Actos was already withdrawn in France yesterday, today, the Federal Institute for Drugs and Medical Devices (BfArM) has responded and told the news agency „Reuters“ explains, the approval for the drug of the Japanese pharmaceutical company Takeda to „further clarification“ to rest.

The French agency for the safety of health products had already withdrawn its approval yesterday after a French study found that the use of the diabetes drug Actos significantly increases the risk of bladder cancer in men. Today, the Federal Institute for Drugs and Medical Devices joined the action of the French authority and declared the approval for Actos because of suspected cancer for the time being to rest.

20 percent higher bladder cancer risk due to diabetes drug
For diabetics affected the new results of the French study a bad news. You may have unconsciously been exposed to an increased risk of cancer for years. According to the current cohort study, the bladder cancer risk in men increases by an average of 20 percent through the use of the diabetes drug Actos (active ingredient pioglitazone). The French Medicines Agency responded promptly and withdrew both Actos and Competact, a combination of Actos and the active substance metformin. The German drug approval office has also drawn from the new study results consequences and let the approval for Actos rest until further notice. The treating physicians are currently no new patients on pioglitazone, the BfArM told the news agency „Reuters“. However, the BfArM recommends that diabetics not sell the active substance on their own initiative, but in any case discuss the further treatment with the responsible doctor.

European Medicines Agency hesitates
While Germany and France have responded promptly due to the suspicion of cancer against the diabetes drug, the European Medicines Agency EMA is currently hesitant for a corresponding decision. The relevant data on the safety of Actos and a possible link to bladder cancer will be reviewed, but so far no changes in the application are recommended, according to the EMA release. In view of the fact that in France alone around 230,000 patients have been treated with the antidiabetic drug and several hundred thousand people are likely to be admitted across Europe, the EMA should not take too much time to verify the facts. After all, the diabetics, who are at risk for health anyway, may expose themselves daily to a significantly increased bladder cancer risk. The allegations of the diabetes drug Actos are not new, because there were discussions about a possible bladder cancer risk immediately after the approval, after this could be proven in corresponding studies in male rats. The EMA will discuss the health risks of Actos at a meeting from June 20-23, and presumably will then decide on the related medication committee.

Pharmaceutical group Takeda so far not ready for any concessions
For the pharmaceutical manufacturer Takeda, the withdrawal of the diabetes drug Actos and the combination drug Competact is a financial fiasco. According to media reports, the largest Japanese pharmaceutical company achieved sales of about 411 million euros in the 2010/2011 financial year with the diabetes drug Actos, which represented about 27 percent of total Group sales. Hardly surprising, therefore, that the Executive Committee has not made any concessions so far. Pharmaceutical company manager Robert Spanheimer, responsible for medicine and science, said that previous tests did not reveal an increase in bladder cancer risk from Actos. However, the company had not had time to evaluate the current French cohort study. However, it is doubtful whether Takeda will confirm this after reviewing the new study results. For in addition to the significant loss of revenue, could possibly pay compensation claims of the affected bladder cancer patients to the pharmaceutical company. (Fp)

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Picture credits: Rainer Sturm