Thousands of lawsuits have been filed and lawsuits continue to mount against Takeda Pharmaceuticals, the maker of Type 2 diabetes drug, Actos (pioglitazone). The U.S. Food and Drug Administration (FDA) approved Actos for the treatment of Type 2 diabetes in 1999.
Lawsuits typically allege that the drug maker was aware that taking Actos could lead to an increased risk of bladder cancer, but failed to disclose this information to the public.
Some of the symptoms of bladder cancer include blood in the urine, frequent urination, or pain when urinating. To confirm cancer of the bladder, testing the urine for blood or abnormal cells and undergoing a bladder cytoscopy to view the bladder and obtain cells are generally conducted, WebMD says. If bladder cancer is confirmed, the stage of that cancer determines the treatment, which may include surgery to remove the cancer, chemotherapy and/or radiation therapy to destroy cancer sells, immunotherapy to attack bladder cancer cells, and/or bladder removal. Because bladder cancer is known to return, ongoing testing and early diagnosis is critical.
Bacillus Calmette-Guerin (BCG), sold under the brands TheraCys BCG and TICE BCG, is one type of medication used to treat bladder cancer. It is not clear how BCG works; however, the drug may stimulate an immune response or cause inflammation of the bladder wall that kills cancer cells within the bladder, according to WebMD.
BCG is only used in the treatment of early-stage cancer, is most typically used to prevent recurrence of noninvasive bladder cancer, and is most often used after cancer has been removed from the bladder via transurethral resection (TUR) surgery, according to WebMD. When used to treat bladder cancer, BCG is given intravesically (through a urinary catheter) into the bladder.
BCG side effects may include:
- Burning or pain with urination, feeling the need to urinate often, urinating small amounts often
- Fatigue, joint aches, skin rash, or fever of less than 101°F (38°C)
- Nausea, vomiting, loss of appetite
- Hepatitis or abscess
- Pneumonitis (inflammation of the lung tissue)
- Inflammation and infection of the prostate, testicles, or epididymis (in men)
- Contraction of the bladder, obstruction of the ureters
- Allergic reaction, disseminated tuberculosis
According to the FDA, taking Actos for one year may significantly increase patients’ risk of developing bladder cancer. The safety label for Actos was updated in June 2011 to reflect this risk and that warning was based on the results of an ongoing 10-year study conducted by Kaiser Permanente.
Studies have continued to suggest that Actos can increase the risk of bladder cancer. For instance, the May 31, 2012 issue of the British Medical Journal found that Actos users were twice as likely to develop bladder cancer after two years. The July 3, 2012 issue of the Canadian Medical Association Journal found that patients taking Actos were 22 percent likelier to develop bladder cancer.