osvaldogaugler51's Space http://osvaldogaugler51.posterous.com Most recent posts at osvaldogaugler51's Space posterous.com Thu, 23 Aug 2012 15:13:00 -0700 Actos Bladder Cancer Lawsuit http://osvaldogaugler51.posterous.com/actos-bladder-cancer-lawsuit http://osvaldogaugler51.posterous.com/actos-bladder-cancer-lawsuit

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 consist of safety details that the use of pioglitazone (Actos) for much more than one year may be connected with an elevated risk 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 danger 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 contain info on the threat of bladder cancer from drugs like Actos.

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

Extra Data for Patients, Info for Healthcare Professionals, and a Data Summary are supplied in the Drug Safety Communication.

FDA recommends that healthcare professionals should:

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

FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the outcomes from the French study. FDA will update the public when much more data becomes readily available.  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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