Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also announced that Takeda Pharmaceuticals, the maker of Actos, had agreed to update the Actos label in Canada to reflect this risk.
Last June, the U.S. Food & Drug Administration (FDA) issued an Actos bladder cancer safety alert based on the same study, and added information about an increased risk of bladder cancer to the “Warnings and Precautions” section of the Actos label. Around the same time, bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries over the summer. Takeda officially recalled Actos from the French market in July 2011.
According to Health Canada’s Actos bladder cancer warning:
- Actos should not be used by patients who have or have had bladder cancer, or those who have blood or red color in their urine.
- Patients taking Actos who begin to have red-colored urine, feel an increased need to urinate, or have pain while urinating are instructed to seek medical attention, as these may be the symptoms of bladder cancer.
- Doctors should evaluate each patient for bladder cancer risk factors before they start taking Actos, including smoking history, family bladder cancer history, workplace chemical exposure, cancer treatments, and radiation therapy.
Takeda Pharmaceuticals, the maker of Actos, has been named in a number of U.S. lawsuits that accuse it of concealing knowledge of Actos’ bladder cancer risks and failing to adequately warn consumer and health care providers about its association with bladder cancer. Some legal experts estimate that Takeda could face as many as 10,000 Actos bladder cancer lawsuits in the U.S.
Late last year, all federally filed Actos bladder cancer lawsuits were ordered transferred to the U.S. District Court, Western District of Louisiana, by the U.S. Judicial Panel on Multidistrict Litigation in December. Judge Rebecca Doherty, who is overseeing the Actos litigation, recently issued “a direct-filing order” for any new claims. This ruling will allow anyone filing an Actos side effects lawsuit to do so directly to the MDL without first having to file a case in local court and waiting for it to be transferred to the federal court by judicial order.