Only a week after officials in both France and Germany began restricting the prescriptions of the diabetes drug Actos made by Takeda Pharmaceuticals, the US Food and Drug Administration (FDA) will now require additional warnings that the use of Actos for more than a year might be linked with an increased risk of developing bladder cancer. Only a week prior, a French study with similar findings propelled French officials to suspend the use of Actos and officials in Germany have recommended that doctors not prescribe Actos to new patients.
The statement by the FDA is in response to a 5-year interim analysis of an ongoing 10-year study of Actos risk of bladder cancer. The FDA’s analysis claims that while they don’t see any overall increase risk of bladder cancer with the use of Actos, they noted an increased Actos bladder cancer risk among patients taking Actos for more than a year as well as those taking higher dosages of Actos. French and German studies, however, did claim that there is an overall increased risk of bladder cancer with Actos as well as an even higher risk the longer Actos is taken.
The French decision was made by its version of the FDA, the AFSSAPS which based their move on a study conducted by a national French insurer which examined results of more than 1.5 million individuals between the ages 40 and 79 years old being treated with Actos between 2006 and 2009. France’s move on Actos has triggered a study by the European Medicines agency, the umbrella drug regulatory agency of Europe. Their study is currently ongoing. A further report in an issue of Diabetes Care, reported 93 incidences of bladder cancer among Actos patients in the FDA Adverse Event Reporting system databases spanning between 2004 and 2009.
Between January 2010 and October 2010 more than 2.3 million patients filled a prescription for diabetes drug Actos. Actos has enjoyed great results following the restrictions placed on sister drug Avandia. Actos has been perceived as the ‘safer’ of the two diabetes drug, but new results linking Actos to bladder cancer might change that perception. In addition to being linked with bladder cancer, Actos has also been recently linked to increased heart failure and bone fractures.
If you or a family member took Takeda Pharmaceutical’s drug Actos (pioglitazone) and you have developed bladder cancer, we encourage you to contact a pharmaceutical lawyer at our firm immediately. An experienced pharmaceutical products liability lawyer at the Willis Law Firm can assist you in legal action in a potential Actos bladder cancer lawsuit against the makers of the drug.
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