New York, New York (PRWEB) June 11, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective drugs, is warning users of Actos (pioglitazone) or Avandia (rosiglitazone) that they may face an increased risk of developing diabetic macular edema. According to a study published in the June 11 online edition of the Archives of Internal Medicine, patients who take thiazolidinediones, a class of type 2 diabetes medications that includes Actos and Avandia, have a two-to-three-fold increased risk of developing the eye disorder. [archinte.jamanetwork.com/article.aspx?articleID=1182550]
According to the Archives of Internal Medicine report, about 20 percent of people with diabetes suffer from macular edema, due to leaking of fluid from blood vessels within the macula. Macular edema can lead to vision loss over time, making it impossible to focus clearly.
For the Archives of Internal Medicine study, researchers at the University of Nottingham in the U.K. collected data on more than 100,000 people with type 2 diabetes included in the British Health Improvement Network database. None of the subjects suffered from diabetic macular edema at the start of the study. After one year, 1.3 percent of patients taking thiazolidinedione developed diabetic macular edema, compared with 0.2 percent of those not taking these drugs. The association was seen whether patients were taking Actos or Avandia.
The study authors called on clinicians to implement more aggressive management of the risk factors for macular edema in patients who take thiazolidinediones. The study authors also said that routine screening for visual acuity should be performed during routine diabetes reviews, especially for patients who take thiazolidinediones.
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.
Since November 2007, Avandia's U.S. label has included a black box warning detailing its association with heart attacks. The black box was added after Dr. Steven Nissen of the Cleveland Clinic published a study in the New England Journal of Medicine showing that patients taking Avandia had a 40 percent increase in the risk of cardiovascular disease. Since 2007, more evidence of Avandia's heart risks has accumulated. In 2010, FDA placed severe restrictions on sales of Avandia, after determining its heart risks outweighed its benefits. [nejm.org/doi/full/10.1056/NEJMe078099; fda.gov/newsevents/newsroom/pressannouncements/UCM226975.htm]
More than 2,500 Avandia lawsuits are consolidated before U.S. District Judge Cynthia Rufe in Avandia Marketing, Sales Practices and Products Liability Litigation (MDL No. 01871), U.S. District Court, Eastern District of Pennsylvania, Philadelphia.
Parker Waichman LLP continues to offer free legal consultations to victims of Actos and Avandia, please contact their office by visiting the firm's Actos injury page or Avandia 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 or Avandia 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