Recent urging by federal regulators that the makers of zinc-containing denture creams, such as Fixodent, take steps to mitigate zinc toxicity risks has renewed calls that such denture adhesives be removed from the market entirely. Parker Waichman LLP, a law firm representing hundreds of people in denture cream zinc poisoning lawsuits, says the Food & Drug Administration (FDA) still is not doing enough to protect consumers from the severe neurological injuries associated with the excessive exposure to zinc in products like Fixodent.
In a February 23 letter to denture cream makers, the FDA wrote that it had 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.†Symptoms reported to the FDA included myeloneuropathy of the extremities and blood dyscrasias, the letter said.
The FDA went on to recommend – but not require – that denture cream makers take several steps to protect consumers from this health threat. One of those recommendations included removing the zinc from denture adhesives entirely, but the agency did not recommend recalls of such products.
Whether manufacturers will follow any of the FDA’s recommendations remains to be seen. A spokesperson for Procter & Gamble, for example, told The Wall Street Journal that, “we take the FDA’s issued letter very seriously,” adding that “providing safe products for consumers is our number one priority.” Procter & Gamble did change the Fixodent label last year to include a caution about overuse of the product.
Of note, GlaxoSmithKline moved over a year ago to remove zinc from three of its Super Poligrip products, citing reports of neurological injuries possibly associated to excessive exposure to zinc in the denture creams. The products have since been reformulated to be zinc-free.
On the heels of the FDA letter to manufacturers, Parker Waichman LLP renewed its plea for a recall of Fixodent and similar products.
“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,” the law firm said in a statement released yesterday.
“For that reason, Parker Waichman 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.” the statement continued.
Andres F. Alonso, a partner with Parker Waichman LLP, is a Co- Lead Counsel to the Plaintiffs’ Steering Committee in the Denture Cream Products Liability Litigation currently underway in the United States District Court for the Southern District of Florida, Miami Division (MDL. 2051). The first trials in that litigation are scheduled to start this year.
