New York, New York - March 3, 2011 – Chaffin Luhana LLP announced that the U.S. Food and Drug Administration (FDA) has issued a warning regarding the use of zinc-containing denture adhesives due to "adverse events related to the use of denture creams." Late last week, the FDA published on its website a February 23, 2011 Notice and Recommended Action ("FDA Notice") that: "zinc contained in some denture adhesives may be a contributing factor in these adverse events. Although zinc is an essential nutrient, overexposure may result in zinc toxicity.” The FDA is encouraging denture adhesive manufacturers to take immediate actions to rectify this serious health concern. To emphasize the severity of the matter, the FDA Notice requires all denture adhesive manufacturers to sign and return a form acknowledging receipt of the FDA Notice and its recommendations. Procter & Gamble ("P&G"), which manufactures zinc-containing Fixodent, is believed to have received the FDA Notice.
Zinc plays an essential role in balancing the body’s nutrients and taking in a small amount of zinc each day is beneficial; however, ingesting an excessive amount of zinc can do great damage to the body and potentially cause zinc toxicity, leading to myeloneuropathy in the extremities and blood dyscrasias, according to the FDA Notice.
The FDA recommends that denture adhesive manufacturers, like P&G, take precautionary measures to ensure the public's safety. First, manufacturers should perform a risk analysis of their labeling to see how they can potentially mitigate the chances of their product causing adverse events. Second, they should conduct a human factors study to determine their consumers' ability to understand the labeling of their product and prevent any potential misuse. Third, manufacturers should modify their labeling to include a statement regarding zinc and specifically how much product can be used safely. Finally, the FDA suggests removing zinc in denture adhesive altogether, and replacing it with a safer ingredient.
The FDA’s recent warning arrives almost one year after GlaxoSmithKline (NYSE: GSK), the makers of Super Poligrip, voluntarily removed zinc from their denture adhesive. Chaffin Luhana LLP applauded this move by GSK. Currently, P&G’s (NYSE: PG) denture adhesive, Fixodent, still contains zinc. Chaffin Luhana LLP is hopeful that with the FDA’s actions, P&G will soon remove zinc from Fixodent and put people before profits.
Chaffin Luhana LLP's attorneys have been heavily involved in the litigation of denture adhesive zinc-poisoning cases since 2008. Managing Partner Eric Chaffin currently serves as court-appointed Co-Lead Counsel and Co-Liaison counsel in state and federal denture cream lawsuits for consumers poisoned by the zinc in denture adhesives such as Fixodent and Super Poligrip. One of Chaffin Luhana's clients, Mark Jacoby, was profiled on ABC World News with Diane Sawyer and ABC Good Morning America earlier this year. Mr. Chaffin appeared on ABC's Good Morning America in 2009, long before GSK removed zinc from its Super Poligrip product line. If you or a loved one presently uses denture adhesive containing zinc and have suffered similar injuries, contact us at 888-480-1123 for a free and confidential no-obligations case evaluation. To learn more about denture cream lawsuits or Chaffin Luhana LLP, please visit our website: www.chaffinluhana.com
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