The FDA has not yet compelled Takeda Pharmaceuticals to issue its own warning on Actos bladder cancer side effects to either doctors or the public.
New York, New York (PRWEB) April 26, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective drugs, is calling upon the U.S. Food & Drug Administrations (FDA) to increase its efforts to inform the public about the risk of bladder cancer associated with the type 2 diabetes drug, Actos. While the agency did issue a Drug Safety Communication this past June regarding the increased risk of bladder cancer posed by long-term use of Actos, the FDA has not yet compelled Takeda Pharmaceuticals to issue its own warning to either doctors or the public.
This contrasts sharply with recent actions of Canadian drug regulator, Health Canada. On April 16, in collaboration with Health Canada, Takeda Canada, Inc. issued a letter to healthcare professionals confirming the potential for Actos to increase the risk of bladder cancer and announcing modifications to the Actos label in Canada. A copy of the Takeda communication was also posted to the Health Canada website. The letter was signed by Dr. Brad Pamenter, Vice President of Medical and Scientific Affairs for Takeda, Canada, Inc. [hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/actos_3_hpc-cps-eng.php]
On June 15, 2011, the FDA issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. The FDA also announced that new information about this risk was being added to the "Warnings and Precautions" section of the Actos label. However, Takeda has never issued a letter to U.S. healthcare providers warning them of Actos' association with bladder cancer, or informing them of the updated U.S. label. In light of Takeda's April 16 communication to Canadian healthcare professionals, Parker Waichman calls upon the FDA to require the company to take similar action in the U.S.[fda.gov/Drugs/DrugSafety/ucm259150.htm]
“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,” states Daniel Burke, attorney at Parker Waichman LLP.
Since the FDA issued its June safety communication, Actos users throughout the country have filed lawsuits alleging the drug caused them to develop bladder cancer. All federally filed Actos bladder cancer lawsuits have been consolidated in a multidistrict litigation in U.S. District Court, Western District of Louisiana before the Honorable Rebecca Doherty (Re: Actos Products Liability Litigation, MDL 2299). In March, Judge Doherty appointed Jerrold S. Parker, founding partner of Parker Waichman LLP, to the Plaintiffs' Steering Committee in the Actos Litigation. [lawd.uscourts.gov/MDL2299/html/news.html]
For more information on Actos bladder cancer side effects, please view this video blog produced by Parker Waichman LLP.
Parker Waichman LLP continues to offer free legal consultations to victims of Actos. If you or a loved one were diagnosed with bladder cancer after taking Actos, please contact their office by visiting the firm's Actos injury page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding Actos side effect lawsuits and Parker Waichman LLP, please visit http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney