FDA Notice Mentions Research That Led to Poligrip Lawsuits

FDA Notice Mentions Research That Led to Poligrip Lawsuits

Absent for months amidst the recent filings of Fixodent and Poligrip lawsuits has been any type of censure by the U.S. Food and Drug Administration of denture cream manufacturers, or indeed any significant comment by the supposed preeminent guardian of public health. That changed, however, when the FDA issued a letter to denture adhesive manufacturers last month acknowledging the potential health risks of denture cream zinc and recommending steps to be taken by manufacturers.

On February 23, the FDA sent a notice to denture cream manufacturers that noted the mounting evidence that the zinc contained in certain dental adhesives may contribute to neurological damage. In doing so, it was acknowledging findings by University of Texas researchers and others that show denture cream zinc can cause a copper deficiency that damages the peripheral nervous system and causes symptoms such as poor coordination, difficulty walking, pain and weakness, and paralysis. Since a study by Dr. Sharon Nations and colleagues from the Southwestern Medical Center in Dallas went public, dozens of lawsuits have been filed against Poligrip manufacturer GlaxoSmithKline and Procter & Gamble, which makes Fixodent. The lawsuits allege that the drugmakers failed to properly warn of the dangerous side effects of denture cream zinc.

Among the recommendations made by the FDA in its notice is that denture cream manufacturers remove zinc from their products. While GSK announced in 2009 that it would remove zinc from Poligrip, P&G still makes Fixodent with zinc. The company has maintained that Fixodent is safe when used as directed, but added recently that it "takes the FDA's issued letter very seriously," and that its number one priority is "providing safe products for consumers."

As the FDA points out in its letter, many denture cream users may not yet be aware of the dangers of zinc overexposure and others, while cognizant of the risks, may not understand how to use the product correctly due to what it calls "potentially misleading labeling." Until the UT study was published, neither GSK nor P&G named zinc as a product ingredient or provided instructions for safe use. And even though they do so now, vague instructions such as "Start with a small amount at first" (appearing on Fixodent) may prove to be insufficient to prevent adverse health effects.

To ensure your safety, consider switching to a denture cream without zinc. And if you have any symptoms of zinc poisoning, visit your doctor immediately. Tests can be performed to measure your zinc and copper blood levels. It is important that zinc toxicity is detected early, as the nerve damage it causes is often irreversible.

Furthermore, you will need a diagnosis of zinc poisoning if you wish to file a Fixodent or Poligrip lawsuit seeking compensation for your injuries. The Rottenstein Law Group, a firm with more than 25 years of experience in product liability law, is currently offering free evaluations of denture cream lawsuit claims. RLG will treat you with sympathy and respect throughout the process of holding a blameworthy company responsible for the harm it has caused. If you believe you or a family member suffered neurological damage caused by Fixodent or Poligrip, don't hesitate to contact RLG for a complimentary case review.

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