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Suspected cancer: Authorities withdraw approval of diabetes drug
After the approval of the diabetes drug Actos in France was withdrawn yesterday, today the Federal Institute for Drugs and Medical Devices (BfArM) has also reacted and told the news agency "Reuters" that the approval for the preparation by the Japanese pharmaceutical company Takeda has been "extended." Clarification ”.
After a French study found that treatment with the diabetes drug Actos significantly increases the risk of bladder cancer in men, the French agency for the safety of health products withdrew the drug yesterday. Today, the Federal Institute for Drugs and Medical Devices joined the French authorities' approach and declared that Actos should be suspended due to suspected cancer.
Diabetes drug increases risk of bladder cancer by 20 percent For those affected by diabetes, the new results of the French study are like bad news. You may have been subconsciously exposed to an increased risk of cancer for years. According to the latest cohort study, the risk of bladder cancer in men increases by an average of 20 percent through the use of the diabetes drug Actos (active ingredient pioglitazone). The French drug approval agency reacted immediately and removed both the Actos product and the Competact drug, which consists of a combination of Actos and the active ingredient metformin, from the market. The German drug approval body has also drawn conclusions from the new study results and has paused approval for Actos until further notice. The treating doctors are currently no longer supposed to put new patients on pioglitazone, the BfArM told the Reuters news agency. However, the BfArM recommends that affected diabetics do not stop taking the active ingredient themselves, but in any case discuss the further treatment with the responsible doctor.
European Medicines Agency hesitates While Germany and France have reacted immediately to the suspected cancer of the diabetes medication, the European Medicines Agency (EMA) is still hesitating to take a decision. The relevant data on Actos' safety and a possible link to bladder cancer are being reviewed, but no changes in use have been recommended, the EMA said. In view of the fact that around 230,000 patients have recently been treated with the antidiabetic drug in France and that there are likely to be several hundred thousand people affected across Europe, the EMA should not take too long to review the facts. Because diabetics, who are already at risk of health, are exposed to a significantly increased risk of bladder cancer every day. The allegations in the direction of the diabetes drug Actos are no novelty, because immediately after the approval there were discussions about a possible bladder cancer risk, after this could be proven in corresponding studies in male rats. The EMA will take a closer look at Actos' health risks at a meeting from June 20-23, and will likely make a decision afterwards.
Pharmaceutical company Takeda has not yet made any concessions For pharmaceutical manufacturer Takeda, the withdrawal of approval for the diabetes medication Actos and the combination preparation Competact is a financial fiasco. According to media reports, the largest Japanese pharmaceutical company generated sales of around 411 million euros with the diabetes drug Actos in the 2010/2011 financial year, which corresponded to approximately 27 percent of total group sales. It is hardly surprising, therefore, that the group management is not yet ready to make any concessions. The manager of the pharmaceutical company, Robert Spanheimer, responsible for medicine and science, explained that previous tests have shown no increase in the bladder cancer risk from the drug Actos. However, the company has not had time to evaluate the current French cohort study. However, it is doubtful whether Takeda will confirm the new study results after reviewing them. Because in addition to the considerable drop in sales, the pharmaceutical company could possibly be entitled to compensation claims for the bladder cancer patients affected. (fp)
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