On August 17, The U.S. Food and Drug Administration (FDA) announced that it has approved the first generic version of Actos. Mylan Pharmaceuticals is the first company to gain FDA approval for producing a generic version. Actos is a popular prescription drug intended to improve glucose (blood sugar) control for adults with Type 2 Diabetes. Manufactured by Takeda Pharmaceuticals, Actos, also known as “pioglitazone,” was the 10th best selling drug in the United States after exceeding sales of $2.4 billion in 2008. Actos users run the risk of encountering side effects that include heart failure, liver failure, macular edema, lactic acidosis, and bone fractures.
ABC News reported in June of 2011 the FDA issued a warning to Actos users stressing the increased risk the drug poses in developing bladder cancer. The FDA issued this warning after reviewing the results of a 5-year analysis undertaken by Takeda Pharmaceuticals which found that extended use (12 months or more) of Actos results in an increased risk of the development of bladder cancer. Additionally, the results showed that patients exposed to high dosages of Actos were at a significantly increased risk of bladder cancer. The FDA’s findings show that depending on the dose and term of use, there exists a 40% increased risk in the development of bladder cancer. These results were derived from a study a 1 0-year study the FDA required Takada Pharmaceuticals to undertake after preclinical trials noted increased occurrences of urinary bladder tumors in subjects.
Currently, the sale of Actos is banned in France and Germany after a study undertaken by the French Medicines Agency found that there was a statistically significant indication that Actos users were at a greater risk of developing bladder cancer. Moreover, the American Diabetes Association concluded that there is a “definite signal for bladder cancer associated with pioglitazone use.”
In light of these findings, although Takeda continues to market Actos, the FDA strongly urges physicians not to prescribe Actos to patients with any history of bladder cancer and has required the manufacturer to improve the warnings and label to include this increased risk of bladder cancer. Despite its own warning, the FDA has contradicted its own statements in approving Mylan Pharmaceutical’s move to sell its own generic form of Actos.
If you or someone you know has developed these side effects from Actos use, you are entitled to representation and compensation immediately. The attorneys at d’Oliveira & Associates are working with the best dangerous drugs lawyers handling these cases and are determined to work for you to get you the help you need.
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