On August 4, 2011, the FDA announced that Actos, a popular drug used to treat patients with Type 2 diabetes mellitus, may be associated with an increased risk of bladder cancer. The new study by the American Diabetes Association also linked Actos to macular edema, a serious eye disease that can lead to blindness. In the past, Actos, like Avandia, has also been linked to an increased risk of heart attack, stroke, and other serious harm.

On September 17, 2010, the FDA issued a Drug Safety Communication linking Actos with an increased risk of bladder cancer among patients who had taken Actos the longest and who had accumulated the highest lifetime dose of the drug. However, the FDA concluded that the finding was not proof that Actos caused bladder cancer, stating that “findings from studies in animals and humans suggest that this is a potential safety risk that needs further study.” The FDA advised patients to continue taking their medication and discuss their concerns with their health care providers.

On June 16, 2011, the FDA issued a new Drug Safety Communication, warning of the link between Actos and an increased risk of bladder cancer based on a review of data from a five-year analysis of an ongoing study. In its Communication, the FDA also referenced an epidemiological study conducted in France, as a result of which France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients. In addition, Actos is scheduled to be fully recalled in New Zealand.

On August 8, 2011, the FDA informed the public that a new drug label has been approved for Actos and other pioglitazone-containing medicines, confirming that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. The new label warns that Actos should not be used by patients with active bladder cancer and should be used with caution by patients with a prior history of bladder cancer. Symptoms of bladder cancer may include blood or red color in the urine, new or worsening urinary urgency or pain during urination.

If you have taken Actos and are experiencing any symptoms associated with bladder cancer or other serious side effects, it is vital to seek immediate medical attention.

If you or your loved ones have taken Actos or other pioglitazone-containing drugs and suffered side effects, please contact the lawyers of The Ferraro law Firm at 1-800-275-3332 or via email for a Free Case Evaluation.

Our offices are conveniently located for clients in Miami, Florida,Washington DC and New York City, NY. We also serve clients nationwide and regularly travel to our clients’ homes and offices.

Important Links:

• FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines
• FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
• FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure
• WebMD: New Bladder Cancer Warning for Diabetes Drug Actos