The FDA’s Actos Warnings
The FDA has looked into the side effects of Actos several times, and though they have required the manufacturer to update its label, Actos still remains on the market. However, because patients who have suffered are standing up and forcing Takeda and Eli Lilly to be held accountable, the once hidden side effects of this drug are coming to light.
The first FDA warning regarding Actos came in September of 2010 when the FDA reviewed data from a ten year study of the connection between Actos and bladder cancer. Though the FDA was reluctant to say much, it did say that it appeared that the longest exposure and the highest doses led to the greatest increases in risk for bladder cancer.
The following year in June of 2011, the FDA revisited the subject, stating more certainly that the use of Actos for more than one year led to an increased risk of bladder cancer.
The FDA also acknowledged that Actos had been banned in France, and in Germany, new guidelines had been adopted stating that new patients should not be started on Actos.
The FDA issued recommendations for both health care providers and patients. For health care providers, the FDA recommended that Actos not be used in patients with active bladder cancer, and should be used with extreme caution in those with a history of bladder cancer.
The agency recommended that patients be aware of the symptoms of bladder cancer, and that they report any suspicious changes to their doctor immediately.
These warnings are coming too late for thousands of patients. When Actos was introduced, it quickly became the best selling diabetes drug. Patients trusted that the drugs wouldn’t make them sicker, and many ended up developing cancer, effecting both their physical lives as well as their emotional and financial lives.
If you have suffered bladder cancer as a result of Actos, you deserve compensation. Contact an attorney at Kirkendall Dwyer LLP to get the answers you need today.