Doctors and attorneys across the nation are warning patients about a link between taking the diabetes drug Actos and the development of bladder cancer. Although the U.S. Food and Drug Administration (FDA) approved Actos for the treatment of diabetes in 1999, pre-approval studies found that a correlation between Actos and bladder cancer existed in lab rats and may extend to humans. The FDA allowed the drug on the market even while definitive studies were pending.
In September 2010, the FDA began a safety review of Actos after the midpoint results of a 10-year study about the drug’s link to bladder cancer were made available. The study, which is still in progress, follows 193,000 patients taking Actos to treat diabetes. The preliminary results of the research show that taking Actos significantly increases the risk of developing bladder cancer.
The patients with the highest risk are those taking the largest doses and those taking Actos for over one year. Patients who have been taking Actos for longer than one year develop bladder cancer at a 40 percent higher rate than people who have never taken Actos.
The 2010 FDA safety review was followed by a May 2011 study of adverse events reported to the FDA by Actos patients and prescribing doctors from 2004 to 2009. According to the study, these reports suggest that Actos patients suffer from a disproportionate risk of developing bladder cancer.
Another study of FDA reports released in August 2011 was based on 22,512 people who reported experiencing side effects after taking Actos. Of this group of patients, 50 of them had developed bladder cancer.
European studies corroborate the findings of the U.S. studies. One study conducted in France found that the risk of developing bladder cancer by Actos patients was 22 percent greater than that of people not taking Actos. As a result of the study, Actos was pulled off the market in France and Germany. For more information on Actos legal issues, please see Phillips Law Offices’ Actos website.
Posted in Actos, Products Liability
Tagged Actos, bladder cancer, diabetes drug, FDA