A tide of negative news is rising against Takeda Pharmaceutical, makers of the diabetes medication Actos. The world’s best-selling diabetes medication is prescribed, along with diet and exercise, to help patients with Type II Diabetes.
But in 2011, the FDA issued a public warning that use of Actos for more than one year “may be associated with an increased risk of bladder cancer.” The statement was added to the Warnings and Precautions section of medications containing pioglitazone, the active ingredient in Actos.
While the FDA conducts ongoing research on the long-term health risks of the drug as a part of a ten-year epidemiological study, Businessweek reports that more than 10,000 cases related to Actos may be headed to court.
Exactly how dangerous Actos is remains unclear, but studies in Europe raised enough concern for The French National Health Insurance Plan to recommend authorities suspend distribution of pioglitazone-containing medicines pending future review. The study, which was conducted using a patient cohort 75 times larger than the FDA-reviewed study from Kaiser Permanente, found that among Actos users, men were at greater risk for bladder cancer than women
The FDA is not so quick to condemn Actos use. So far, the agency only recommends that doctors avoid prescribing Actos to people who have an increased risk of cancer such as active bladder cancer or patients with a prior history of bladder cancer. The FDA also notes that increased exposure to Actos from taking the drug regularly over a long period of time is an important risk factor.
According to Businessweek, laywers for Takeda and some of the plaintiffs are seeking to consolidate the Actos suits in federal court before U.S. District Judge James Zagel in Chicago, Illinois or before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana. This is a typical step in similar cases because it allows for streamlining of document exchange and review, and prevents duplicate efforts.
In 2010 alone, the National Cancer Institute reported 70,530 new cases of bladder cancer in, and 14,680 deaths. Typical symptoms associated with bladder cancer include blood in the urine, urinary urgency, painful urination and pain in the back or abdominal region.
If you or a loved one has experienced any of these symptoms while taking Actos, please contact us today for a free, no-obligation consultation about your potential case.
Photo Credit: Clay