The FDA approved Actos for treatment of diabetes in 1999, but complaints associated with bladder cancer have continued through the years. In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer. A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.
In September 2010 the FDA ordered a safety review of Actos. The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos. A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year. Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.
Actos Has Been Linked To Increased Risk of Developing Bladder Cancer
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A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.
If you or a loved one has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuries. The Brandi Law Firm is a leader in nationwide pharmaceutical litigation for decades and is now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 800-481-1615