Attorneys are currently investigating the use of Actos for its use in treating Type 2 Diabetes. Warnings have been issued by the FDA stating that Actos is possibly linked to a higher risk of bladder cancer. This has mainly been seen in patients that use Actos for longer than a year.
People who are suffering from bladder cancer are encouraged not to use Actos. The FDA warns Actos should be used cautiously by patients who have a history of bladder cancer. The information from the FDA comes from the data obtained from an ongoing study.
Side Effects of Actos
Side effects of this drug also include an increased risk of fractures, congestive heart failure, and liver disease. There is a black box warning for heart failure on the label, but a whistleblower claims that a known fact of myocardial infarction (heart attack) has been downplayed. Information about the bladder cancer risk is supposed to be added to the label.
FDA Warning for Actos
The original FDA warning back in 2002 dealing with the side effects of Actos stated: “In insulin combination studies, a small number of patients with a history of previously existing heart disease developed congestive heart failure when treated with Actos in combination with insulin.”
Actos Under Fire
France and Germany both stopped the sale of Actos back in 2011. Actos and a similar drug, Competact, were highly criticized in Europe after a study showed an increased risk of bladder cancer in diabetic patients. The announcement that sales were being halted could affect over 230,000 people who currently use Actos or Competact just in France alone.
Lawsuits are being filed against Takeda Pharmaceuticals, the maker of Actos. The lawsuits are alleging that that people who took the drug developed bladder cancer. According an article in the Washington Post, lawsuits were being filed as early as August 2011.
Actos Linked to Heart Attacks
A former pharmaceutical consultant for Takeda stepped up and alleged that the company didn’t heed her warning about cases of myocardial infarctions and that Takeda did not report these adverse events to the FDA as they should have.
Concerns about the safety of the drug are the focus of the many lawsuits that are being filed. The Actos lawsuits are of great interest because of the black box warnings that were put on Actos and Avandia back in 2007. These warnings only specified CHF (congestive heart failure), not HEART ATTACK. This could lead to more lawsuits from people who suffered a heart attack while taking Actos. Some might even think the black box warning was for heart attacks as well as CHF.
Links to Kidney Failure and Rhabdomyolysis
The FDA had previously announced a possible safety concern related to rhabdomyolysis. Rhabdomyolysis is a rare sickness where the muscle fibers deteriorate and cause myoglobin to be released in the blood stream. Rhabdomyolysis can cause kidney failure. Symptoms of this illness include muscle aches, weakness, and pain, nausea, dark colored urine and vomiting. These symptoms mimic other diseases, so it is important that you consult with your doctor right away.
If you or a loved one has suffered heart failure, liver damage, bladder cancer, or any other serious side effects while taking Actos, you need to consult with a personal injury attorney as soon as possible.