The maker of Actos, confirmed the potential for Actos to increase the risk of bladder cancer in an April 16, 2012, letter to health care professionals announcing modifications to the Actos label in Canada.
New York, New York (PRWEB) April 24, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective drugs, is warning Actos (pioglitazone) users that long-term use of the type 2 diabetes medication may place them at an increased risk of developing bladder cancer. Takeda Canada Inc., a division of Takeda Pharmaceuticals, the maker of Actos, confirmed the potential for Actos to increase the risk of bladder cancer in an April 16, 2012, letter to health care professionals announcing modifications to the Actos label in Canada.
The letter, signed by Dr. Brad Pamenter, Vice President of Medical and Scientific Affairs for Takeda, Canada, Inc., 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.
Actos was brought to market in the U.S. in 1999 by Takeda Pharmaceuticals America Inc. and Eli Lilly and Co., as a treatment for type 2 diabetes. Actos, now one of Takeda's top-selling drugs, had global sales last year of $4.8 billion and accounts for 27 percent of the company's revenue. [businessweek.com/news/2012-03-13/takeda-actos-judge-names-lead-attorneys-in-u-dot-s-dot-bladder-cancer-lawsuits]
On September 17, 2010, the U.S. Food & Drug Administration (FDA) announced it had begun an Actos safety review after preliminary data from a study conducted by Kaiser Permanente demonstrated that the risk of bladder cancer increases with increasing dose and duration of Actos use, reaching statistical significance after 24 months. On June 15, 2011, the FDA issued another safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. When compared to persons never treated with Actos, taking the drug for more than 12 months was associated with a 40 percent increase in the risk of developing bladder cancer, the agency said. The FDA mandated that new information about this risk be added to the "Warnings and Precautions" section of the Actos label.[fda.gov/Drugs/DrugSafety/ucm259150.htm]
Since the FDA warnings, Actos users throughout the country have filed lawsuits alleging the drug caused them to develop bladder cancer. Lawsuits alleging Actos caused bladder cancer and other serious health problems 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]
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
Herbert Waichman, Partner