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Introduced in the 1999s, Actos was approved for treatment of Type 2 diabetes to control blood sugar. The medication replaced Avandia, assumed to have more associated risks, but short-lived hype gave way to harmful side effects, like bladder cancer and heart disease. As of 2011, patients or family members of patients prescribed Actos have been taking their claims to court against manufacturers Takeda Pharmaceutical and Eli Lilly.
Studies since Actos’ introduction have found correlation between its usage and a greater risk of developing bladder cancer. The side effect has been associated with Actos, ActoPlus Met, ActoPlus Met XR, and Duetact.
In 2011, the FDA put out a Safety Announcement following data from a five-year analysis concerning the manufacturers’ ongoing study. Results showed that patients on the drug for longer than a year had a 40-percent greater chance of developing bladder cancer.
As a result, the FDA advised that pioglitazone, Actos’ primary component, should not be prescribed to individuals who have bladder cancer and must be used with caution by patients with a history of the condition. As well, the FDA advised patients to look for the following signs:
- Blood in urine
- Back or lower abdominal pain
- An urgent need to urinate
- Pain during urination
The FDA’s warning further changed how Actos is labeled and revised the patient medication guide doctors reference.
Other Side Effects
Other side effects have emerged from Actos usage, including congestive heart failure, liver damage, blindness, bone fractures, and kidney damages.
Heart failure appears the most prominent. Clinical trials allegedly found a large percentage of recipients experiencing a serious heart failure event or death from heart failure, compared to those given a placebo.
Also associated with heart-related risks is edema. Fluids begin accumulating in the body, and when heart failure occurs, major organs begin to shut down. Fluids, as a result, build up in tissue, lungs, the liver, and extremities, exacerbating any heart-related conditions. The occurrence has since resulted in a black box warning being added.
Filing a Lawsuit
As Actos-related claims have been going to court as early as 2011, mass tort cases are pending in Illinois and California. As of 2013, 2,500 federal lawsuits are further pending in the U.S. District Court for the Western District of Louisiana. Plaintiffs have sought compensation for medical bills, pain and suffering, and other damages.