FDA Updates Actos Risks; Could Affect Kentucky Patients

Kentucky- Actos RisksThe well-known type 2 diabetes medication Actos is manufactured and marketed by Eli Lilly and Takeda Pharmaceuticals. The product was initially approved by the U.S. Food and Drug Administration (FDA) as a drug to help type 2 diabetes patients better manage their conditions. However, Actos lawsuits have been filed against the manufacturer after patients developed bladder cancer, and the FDA is beginning to take notice of several potentially severe and life-threatening complications.

Actos Patients Pursue Claims

While Actos lawsuits continue to proceed, an early bellwether trial in Federal Court in Louisiana in April 2014 resulted in a $9 billion  punitive damages award. Since then, the manufacturers have been named in other lawsuits, including one filed on behalf of Blue Cross and Blue Shield. According to court documents, the defendants are accused of failing to warn of Actos risks such as bladder cancer, thus causing the insurance company to pay for its policyholders’ medical expenses when the patients should have allegedly never been injured.

Attorneys estimate that Takeda Pharmaceuticals could be facing more than 10,000 Actos lawsuits. With several hundred cases currently pending alleging severe Actos risks, many plaintiffs and the manufacturers filed to move all pending claims to one district court. All federally-filed Actos lawsuits were transferred to the U.S. District Court for the Western District of Louisiana on December 30, 2011.

FDA Gets Involved, Cites Actos Risks

On June 15, 2011 the FDA issued a drug safety communication as an update to ongoing safety reviews of Actos. According to the agency, the use of Actos for more than 12 months could potentially increase a patient’s risk of developing bladder cancer. The FDA stated that the medication’s warning label would be updated to reflect this risk and that it would continue to analyze results from a 10-year-lnog epidemiological study as well as current research underway in France.

While bladder cancer is the most commonly alleged complication in Actos lawsuits and is evidenced by frequent urination, painful urination, back pain, and frequent bladder infections, patients have also claimed to have sustained eye injuries as well as cardiovascular complications such as heart attacks and congestive heart failure. Unfortunately, most patients are taken by surprise when they are diagnosed with cancer, as it often does not present any severe or life-threatening symptoms. Instead, many are unaware that they are living with the condition until after they are tested for recurring urinary tract infections or during routine medical exams.

Attorney Group for Kentucky Can Help

If you or a loved one developed bladder cancer in Kentucky and you believe that Actos was to blame or if you have concerns about Actos risks you are facing, please contact Attorney Group for Kentucky today for more information about your options. We can help answer your questions and help you determine if you have a case. We can also connect you with one of our local affiliated attorneys in Kentucky – all at no cost to you.