Since Actos was Approved in 1999 to Treat Type-2 Diabetes, the FDA has Added Warnings to the Actos Label Regarding its Association with Bladder Cancer and Heart Failure.
New York, New York (PRWEB) March 30, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective drugs, continues to evaluate Actos (pioglitazone) lawsuit claims on behalf of individuals who suffered from bladder cancer, congestive heart failure or heart attacks while taking Actos. According to Parker Waichman LLP attorney Daniel C. Burke, Actos is a type-2 diabetes drug that increases the body’s sensitivity to insulin. Actos was approved for sale by the U.S. Food & Drug Administration (FDA) in 1999, but has now been linked to a serious risk of bladder cancer. Mr. Burke advises Actos users to see their doctor immediately if they have a diagnosis of bladder cancer or have noticed pain with urination, increased frequency urination, or blood in their urine. An overview of Actos and its possible side effects is provided by Mr. Burke in this video produced by Parker Waichman LLP.
According to Public Health Watchdog, the FDA announced in September 2010 that it was conducting an ongoing safety review concerning the increased risk of bladder cancer associated with exposure to Actos. Nearly a year later, in June 2011, the agency said in an update “that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” According to Public Health Watchdog, the agency warned healthcare professionals against prescribing Actos in patients who have bladder cancer or have a history of bladder cancer. Information regarding bladder cancer was added to the "Warnings and Precautions" section of the Actos label.[fda.gov/Drugs/DrugSafety/ucm259150.htm]
Public Health Watchdog also reports that Actos’ effects on the heart have been cause for concern. A boxed warning was added to the Actos label in August 2007 “to emphasize that pioglitazone may cause or exacerbate heart failure, particularly in certain patient populations.” In August 2010, a study conducted by HealthCore Inc.and published in the British Medical Journal linked Actos to the same dangerous heart side-effects as the rival drug Avandia. The study analyzed the medical records of 28,938 people from 2001 to 2005 who took either Avandia or Actos, and showed that about 4 percent of each group died from heart failure or a heart attack.[fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124178.htm; bmj.com/content/342/bmj.d1309]
According to a report from Newsinferno, a former Actos medical reviewer has alleged in a whistleblower lawsuit that Takeda Pharmaceuticals, the maker of Actos, improperly reported Actos adverse events, including heart failure and bladder cancer cases, to the FDA. Whistleblower Helen Ge claims that her contract with Takeda was ended after she complained about the way medical reviewers had been instructed to report Actos adverse events to the FDA. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’ safety profile and to increase sales,” Ge's complaint states. The Actos whistleblower lawsuit was filed in September 2011, and unsealed in February 2012 in U.S. District Court, District of Massachusetts. (ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043)
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). Earlier this month, 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, or suffered heart failure or a heart attack 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 bladder cancer, congestive heart failure and heart attack 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