The U.S. Food and Drug Administration (FDA) has informed the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines (Actos) to include safety information that the use of pioglitazone (Actos) for more than one particular year may possibly be linked with an improved danger of bladder cancer.  Actos bladder cancer lawyers are pursuing lawsuits on behalf of victims who have developed bladder cancer while using Actos.

Information about this threat will be added to the Warnings and Precautions section of the label for pioglitazone-containing (Actos) medicines by the manufacturers. The patient Medication Guide for these medicines will also be revised to consist of information on the threat of bladder cancer from drugs like Actos.

This safety details is based on FDA’s evaluation of information from a 5-year interim analysis of an ongoing, ten-year epidemiological study. The 5-year results showed that although there was no overall increased threat of bladder cancer with pioglitazone use, an improved threat 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 a current epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone. Based on the outcomes of this study, France has suspended the use of pioglitazone and Germany has advised not to start off pioglitazone in new patients.

Additional Information for Patients, Data for Healthcare Experts, and a Data Summary are supplied in the Drug Safety Communication.

FDA recommends that healthcare pros really should:

1.  Not use pioglitazone in patients with active bladder cancer.
2.  Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar manage with pioglitazone should be weighed against the unknown dangers for cancer recurrence.

FDA will continue to evaluate information from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when a lot more info becomes obtainable.  Patients who are on Actos for an extended period who have developed bladder cancer may be able to pursue an Actos bladder cancer lawsuit.

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