Japan-based Takeda Pharmaceuticals, manufacturer of the bestselling type 2 diabetes drug Actos, is facing a raft of legal battles and problems over the treatment. The drug has already been removed from sale in France and Germany because of pressure from regulators, due to its link to an increased risk of bladder cancer.
The lawsuits against Actosalso follow warnings from the Food and Drug Administration (FDA) in the United States and the European Medicines Agency concerning the cancer risk, although they have allowed it to remain on sale. In addition, GPs are being advised not to prescribe the once-a-day pill, which helps to improve the body's sensitivity to insulin and control blood sugar levels, for those who have or previously had bladder cancer.
Actos became the world’s leading diabetes drug after Avandia, which is in the same class of treatment, was found to increase the risk of heart attack and was prevented from being sold in the EU.
The FDA assessed data from a long-term study of Actos safety, concluding that the risk of bladder cancer was 40 per cent greater for patients taking Actos for at least a year, although it was still only a slight risk.
In the United States, many lawsuits are starting to be filed concerning the drug, by patients who took the pills every day for many years, and who now claim that the drug has caused bladder cancer.
Bestselling diabetes drug Actos facing multiple legal challenges
Mon, 08 Aug 2011
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