The Food & Drug Administration (FDA) has approved new warnings associated with the risk of bladder cancer from Actos, a diabetes drug sold by Takeda Pharmaceuticals. In a Drug Safety Communication issued on August 4, 2011, the FDA released the final language for the new Actos bladder cancer warning, indicating that patients who use the diabetes drug for more than a year may face an increased risk of bladder cancer. The new drug label recommends that healthcare providers not use Actos in patients with active bladder cancer and exercise caution with patients who have a history of bladder cancer.
The new warnings for Actos users are the result of a study conducted in June 2011, in which regulators in France and Germany announced they were suspending sales of Actos because of a possible bladder cancer risk. France and Germany regulators decided to ban Actos after a study commissioned by the French Medicines Agency found that people taking Actos were more likely to develop bladder cancer. During the study, regulators observed cancer rates in 155,000 people taking Actos in France from 2006 to 2009 and 1.3 million other diabetics who were not receiving the drug. The study found an approximate 22 percent increased risk of bladder cancer in those taking Actos compared with diabetics taking other drugs. The bladder cancer risk was highest in those receiving an aggregate Actos dosage of 28,000 mg or more during the study period.
In May 2011, the FDA conducted a study on the adverse effects of Actos. Relying on the Adverse Event reports to the FDA from 2004 to 2009, the FDA advised that Actos patients faced a “disproportionate risk” of bladder cancer. The study examined a half million side effect reports associated with various diabetes medications and found that one-fifth of those involving bladder cancer occurred in Actos patients.
If you or a loved one have taken Actos and have been diagnosed with bladder cancer, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Contact one of our Georgia Actos lawyers or visit our website, www.pmkm.com.
Disclaimer: All use of the Actos mark are for informational and product identification purposes only. This post should not be taken as either medical or legal advice, but instead should act as a resource in providing general information that may be useful to the general public. Pope McGlamry is not affiliated with the manufacturer of Actos, Takeda Pharmaceutical, or its distributors.