Pioglitazone, manufactured by Takeda Pharmaceutical Co under the drug name Actos, is a leading medication used for the treatment of type 2 diabetes mellitus, a condition in which the body is unable to properly process insulin. Despite known links to congestive heart failure, respiratory distress and liver failure, Actos remains the top selling diabetes medication in the United States, with 2010 sales revenues estimated at $4.3 billion. Reports have also recently surfaced associating Actos with the development of macular degeneration, a condition affecting the retina, which can lead to visual disorders and blindness.
The United Stated Food and Drug Administration issued a safety announcement on June 15, 2011 concerning the increased risk of bladder cancer in patients who have taken Actos for the treatment of type 2 diabetes. Although the FDA has not issued an official recall, the agency issued a statement confirming that information regarding the risk of bladder cancer would be added to the Warnings and Precautions section of the Actos prescription label. A five-year study conducted by the FDA revealed an increased risk of bladder cancer, resulting in a subsequent warning announcement issued on September 17, 2011.
Following a recent epidemiological study, The French Agency for the Safety of Health Products withdrew Actos from the market on June 9, 2011 after a comprehensive epidemiological study revealed numerous cases of bladder cancer associated with the medication.
Bladder cancer, a potentially life-threatening condition, generally originates in cells lining the interior wall of the bladder. Aggressive bladder cancer tumors may spread to organs and tissues, including the rectum, uterus, vagina and prostate glands. Lymph node involvement can lead to infiltration into the bones, muscles, liver, lungs and central nervous system. Treatment for bladder cancer typically involves surgical removal of the tumor, followed by aggressive chemotherapy and radiation regimens.
Numerous lawsuits have been filed against Takeda Pharmaceutical Co. stemming from the linkage of Actos with bladder cancer. Class action lawsuits filed in federal jurisdictions allege that the development of bladder cancer is a direct result of the company's failure to research and assess the risks associated with Actos. It is alleged that despite Takeda's knowledge of numerous cases of bladder cancer linked to Actos, the company failed to issue warnings to consumers and physicians.
Serious life-threatening complications linked to Actos have led to numerous personal injury, medical malpractice and product liability lawsuits against Takeda. Lawsuits allege that despite Takeda's knowledge of the serious risks and complications associated with Actos, the company failed to take responsible actions to remove the drug from the pharmaceutical market. Allegations include negligence, product liability, fraud, deceit and failure to warn of risks associated with Actos.
Since 2010, Takeda has faced intense scrutiny from medical professionals and government agencies for its failure to warn consumers and physicians of the potential life-threatening risks associated with Actos. In August of 2011, the Associated Press reported that Takeda is facing thousands of Actos lawsuits as a result of bladder cancer. Despite multi-agency reviews, investigative research studies, clinical trials and mounting litigation, neither the FDA nor Takeda have undertaken steps to issue a recall of this dangerous drug. Recall petitions have been circulated by medical and research professionals urging the FDA to immediately recall Actos before additional bladder cancer cases and resulting deaths can occur.