After French and German drug regulators announced last week that they were suspending the diabetes drug Actos due to concerns about a potential risk of bladder cancer, other European countries have indicated that they are also reviewing the potential side effects of Actos.
Actos was pulled from the market last week in France after authorities identified a slight increase in the risk of bladder cancer from Actos during a review of public insurance data.
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has indicated that it will meet this week to discuss whether an Actos recall should be issued in that country. In addition, experts with the European Medicines Agency are schedule to meet and discuss the potential Actos bladder cancer risk at a meeting next week.
In the United States, the FDA announced in September 2010 that it was investigating the potential for cancer from Actos after interim data from an ongoing 10 year study by the drug’s maker, Takeda Pharmaceuticals, suggested that users may have an increased risk of cancer the longer they took Actos. However, to date, the FDA has not released any conclusions or recommendations.
Last month, a study by Italian researchers found a disproportionate number of Actos bladder cancer reports in the FDA’s own Adverse Event Reporting System Records. However, that study did not establish a causal effect between Actos and bladder cancer.
Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is Takeda Pharmaceuticals’ best-selling drug, with sales of $3.4 billion last year.
Sales have increased in recent years, after a number of studies have suggested that Actos may be safer than its competitor, Avandia, which has been linked to an increased risk of heart attacks and deaths.
A number of former users who have been diagnosed with bladder cancer have contacted lawyers in recent months to determine whether they may be entitled to compensation through an Actos lawsuit as a result of the manufacturers failure to adequately warn about the potential bladder cancer side effects.