|
FDA warns of Actos bladder cancer risks, JAMA affirms
A month after the FDA warned about the increased risk of bladder cancer for diabetics who have taken Actos (pioglitazone) for over one year, the Journal of the American Medical Association reports that the FDA is continuing to evaluate Actos bladder cancer data from their own studies (based on a decade of epidemiological research) and the results of an influential French study.
The JAMA article by Dr. Joan Stephenson comes on the heels of international Actos news: both Germany and France have suspended Actos usage in their national markets while they wait for the European Medicines Agency (EMA) to issue a statement about the diabetes drug’s safety.
The FDA has not suspended Actos usage in the United States, but they have advised health care professionals “not to use pioglitazone in patients with active bladder cancer and to prescribe the drug with caution for patients with a prior history of bladder cancer, weighing the benefits of blood glucose control against the unknown risks for cancer recurrence.”
Actos bladder cancer risks increase with amount of time on Actos and dosage amount
Dr. Stephenson notes that the FDA found that it was not merely exposure to Actos, but the accumulation of Actos exposure over time, that was associated with an increased risk of bladder cancer as the worst among several Actos side fffects:
“Results based on 5 years of data showed that although pioglitazone use was not associated with an overall increased risk of bladder cancer, there was an increase in the risk of the malignancy among patients with the longest exposure to pioglitazone and in those exposed to the highest cumulative dose of the drug.”
Actos bladder cancer warning to be added to the warning label, FDA says
Though the FDA has not gone as far as the regulatory agencies in France and Germany, suspending Actos usage entirely, the FDA says they will add a warning about the bladder cancer risks on the warnings and precautions section of the label on all medications containing pioglitazone.
In addition, the FDA will revise the patient medication guide (for all medications that contain pioglitazone—Actos being the most popular pioglitazone-based drug) to include information on the relationship between extended pioglitazone exposure and bladder cancer.
Did your Actos usage result in bladder cancer? Get help paying for your cancer treatment.
Weitz & Luxenberg attorneys have a long history of helping patients defend themselves against defective medical devices and medications. As the pharmaceutical market has grown, the opportunities for calamitous drug interactions and side effects have grown right along with them. Our attorneys can protect you from the costs incurred by severe and fatal reactions to medications like Actos. Contact us for more information about your potential Actos lawsuit.
For more information, call 1-800-476-6070 or fill out a form to receive a free legal consultation.
Acknowledgments:
- http://www.reuters.com/article/2011/06/24/takeda-actos-idUSL3E7HN2J820110624
- The Journal of the American Medical Association, July 13, 2011—Vol 306, No. 2.
see also:
Actos Lawsuit 2011
Looking to file an Actos lawsuit in 2011? We can help.Are you looking to file an Actos lawsuit? 2011: Weitz & Luxenberg is currently investigating cases regarding Actos and bladder cancer. Tell us your story.
Actos Bladder Cancer
Actos Bladder Cancer Lawsuit and Litigation | Free Case ReviewActos Bladder Cancer - Weitz & Luxenberg is currently investigating the link between Actos and bladder cancer. Visit Weitz & Luxenberg to tell us your story
Actos Bladder Cancer
Actos Bladder Cancer and Actos Recall, Litigation, Lawyer and Lawsuits.A recent FDA warning implies that diabetes drug Actos could be related to instances of actos bladder cancer. Visit Weitz & Luxenberg to learn more.
