FDA's Office of Compliance Center for Devices and Radiological Health, sent a "NOTICE and RECOMMENDED ACTION” to denture adhesive manufacturers, asking that they act to mitigate the risk of zinc toxicity posed by overuse of their products.
Port Washington, NY (PRWEB) February 28, 2011
Parker Waichman Alonso LLP, a national law firm dedicated to protecting the rights of injured people, applauds the U.S. Food & Drug Administration (FDA) for moving to mitigate the risks of zinc toxicity posed by excessive use of Fixodent and other denture adhesives made with zinc. The firm continues to call on Procter & Gamble, the maker of Fixodent, as well as other manufacturers of zinc-containing denture adhesives, to recall these products immediately, as they continue to pose a significant public health threat.
A small amount of zinc is necessary for a balanced diet. However, excessive exposure to zinc in denture creams can result in copper depletion, leading to the development of severe neurological injuries and blood disorders. In August 2008, an article appearing in the peer reviewed journal "Neurology" specifically linked excessive exposure to zinc in denture adhesives to "profound neurologic disease" in four patients reviewed.
On February 23, 2011, Steven D. Silverman, director of the FDA's Office of Compliance Center for Devices and Radiological Health, sent a "NOTICE and RECOMMENDED ACTION” to denture adhesive manufacturers, asking that they act to mitigate the risk of zinc toxicity posed by overuse of their products. In its notice, the FDA said it has received numerous reports of adverse events related to the use of denture adhesives, and that literature and research “suggests zinc contained in some denture adhesives may be a contributing factor in these adverse events.”
The FDA has asked denture cream manufacturers to consider taking several steps to address the risk of zinc toxicity posed by their products, including: Performing risk analysis of their denture cream labels to assess how the zinc poisoning risk can be mitigated; conducting studies to assess consumer understanding of labeling and the potential for misuse of zinc-containing denture creams; modifying labels to state products contain zinc and define maximum safe usage in easily understood terms; and replacing zinc with an ingredient that presents less health risks in situations of overuse.
The FDA action comes one year after GlaxoSmithKline, the maker of Super Poligrip denture adhesive products, announced it would stop the manufacture, distribution and advertising of three Super Poligrip products that contained zinc. The Super Poligrip adhesives have since been reformulated to be zinc-free.
In March 2010, Procter & Gamble began cautioning consumers about zinc in Fixodent denture creams on its website. At the same time, Procter & Gamble also began shipping Fixodent with updated label instructions on how to properly apply the product. The zinc, however, remains in Fixodent.
While the recent action by the FDA is a welcome development, the recommendations made by the agency do not go far enough to protect consumers from the significant heath risks posed by zinc-containing denture creams. By that measure, the caution added to Fixodent by Procter & Gamble last year also falls short. For that reason, Parker Waichman Alonso LLP continues to call for a full recall of Fixodent and all other denture adhesives made with zinc that are currently being marketed in the U.S.
Parker Waichman Alonso LLP has filed numerous lawsuits on behalf of the victims of Super Poligrip and Fixodent. These lawsuits allege that the manufacturers of these denture creams misled consumers about their risks and failed to provide adequate warnings and instructions for use. Those actions, along with scores of other denture cream zinc poisoning lawsuits filed in federal courts around the country, have been consolidated in the Denture Cream Products Liability Multidistrict Litigation, currently pending in the United States District Court for the Southern District of Florida, Miami Division, before the Honorable Judge Cecilia Altonaga (MDL No. 2051). In an order filed on July 13, 2009, Judge Altonaga appointed Andres F. Alonso Esq., a partner with Parker Waichman Alonso LLP, as Co- Lead Counsel to the Plaintiffs' Steering Committee in the Denture Cream Products Liability Litigation. The first trials in the litigation are expected to begin this year.
Parker Waichman Alonso LLP continues to offer free consultations to the victims of denture cream zinc poisoning. If you or a loved one uses or have used Super Poligrip or Fixodent and now suffer from neurological problems, please contact our office by visiting http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
About Parker Waichman Alonso LLP
Parker Waichman Alonso LLP is a leading personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York, New Jersey and Florida. Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective drugs, medical devices and other products.
For more information on Parker Waichman Alonso LLP, please visit:
http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Contact: Parker Waichman Alonso LLP
David B. Krangle, Esq.