A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, to issues its own Actos bladder cancer warning to doctors in the U.S. Takeda recently sent such a warning to providers in Canada, in collaboration with that country’s FDA counterpart, Health Canada.
Last June, the FDA did issue a Drug Safety Communication regarding Actos and bladder cancer. In the communication, the FDA announced that new information about this risk was being added to the “Warnings and Precautions” section of the Actos label. However, Takeda did not issue its own statement at the time.
By contrast, Health Canada’s recent Actos bladder cancer warning was accompanied by a letter to healthcare providers from Takeda itself. According to Parker Waichman’s statement, the letter was signed by Dr. Brad Pamenter, Vice President of Medical and Scientific Affairs for Takeda, Canada, Inc. The document states that “Health Canada has recently completed a safety assessment of the available data and the Product Monograph (PM) was updated to reflect the potential risk of bladder cancer in treated patients.” Among other things, the modified label will acknowledge that findings from new studies reveal that there is a potential increased risk of bladder cancer in patients treated with pioglitazone-containing products.
The firm is now calling on the FDA to compel Takeda to issue a similar warning for healthcare providers in the U.S.
“We are hopeful that the FDA will take the strongest action possible to protect patients by requiring Takeda to directly notify the physicians of serious adverse events associated with taking Actos,” Daniel Burke, an attorney at Parker Waichman LLP, said in the firm’s statement.
The FDA’s June 2011 communication was a follow-up to one the agency issued in September 2010 after preliminary data from a study conducted by Kaiser Permanente demonstrated that the risk of bladder cancer rises with increasing dose and duration of Actos use, reaching statistical significance after 24 months. 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.
Since last summer, score of people throughout the U.S. have filed lawsuits against Takeda, alleging Actos caused them to develop bladder cancer. As we’ve reported previously, all federally filed Actos bladder cancer lawsuits were ordered transferred to U.S. District Court, Western District of Louisiana, by the U.S. Judicial Panel on Multidistrict Litigation in December. Plaintiffs in the Actos multidistrict litigation accuse Takeda Pharmaceuticals and other defendants of concealing knowledge of Actos’ bladder cancer risks and failing to adequately warn consumer and health care providers about its association with bladder cancer. According to Parker Waichman’s statement, its Founding Partner, Jerrold Parker, is a member of the Plaintiffs’ Steering Committee in that litigation.