The lawyers at Shoop | A Professional Law Corporation reiterate a recent U.S. Food and Drug Administration ("FDA") Drug Safety Communication and Advisory, which serves as an update to an ongoing safety review of Actos (pioglitazone) and the increased, associated risks of bladder cancer.
FDA advises the public that the use of diabetes medication, Actos (pioglitazone), for sustained periods of one year or more could be associated with elevated and increased risks of the development of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for Actos medicines. The patient Medication Guides for these meds shall also be re-written to include product warnings related to the risk of development of bladder cancer.
The drug, Pioglitazone, sold under the brand name, Actos, and addtionally sold in combination with metformin, is used generally along with diet and exercise to improve control of blood sugar in adults with Type-2 diabetes. From approximately January of 2010 through October of 2010, roughly 2.3 million patients filled prescriptions for this drug from outpatient retail pharmacies. Safety information provided is based upon FDA's review of data from a coordinated, 5-year analysis of an ongoing, ten-year epidemiological study. The 5-year results demonstrated an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.
FDA is also aware of recent studies conducted in France which tend to suggest an increased risk of bladder cancer with use of pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.
FDA recommends that healthcare professionals should:
- Not use pioglitazone in patients with active bladder cancer.
- Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.
Shoop | A Professional Law Corporation continues to accept Actos cases. If you or a family member has suffered side effects as a result of use of Actos or any other dangerous drug, you need legal counsel with significant experience in product liability matters. Contact us today to speak with an experienced product attorney.
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