FDA comments on denture paste poisoning reports

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by JANET ST. JAMES / WFAA

wfaa.com

Posted on February 19, 2010 at 6:10 PM

Updated Friday, Feb 19 at 8:29 PM

A spokesperson with the Food and Drug Administration now says they became concerned about the potential of zinc overload from denture adhesives early last year.

The news comes after a five-year News 8 investigation into denture paste poisoning in which the FDA was contacted numerous times.

Thursday, GlaxoSmithKline announced it will quit making and supplying stores with Super PoliGrip until it can be reformulated zinc-free.

Denture adhesives were FDA approved more than 20 years ago as a Class 1 medical device. That classification means a product isn't metabolized in the body and presents the lowest potential risk to consumers.

Studies now show zinc, which is in some denture creams, can be absorbed into the body through the gums or when swallowed.

High levels of zinc can cause medical conditions ranging from anemia to nerve damage called neuropathy.

"I can barely walk," said Tammy Baugh, of Collin County. "I have to use a walker; it's getting harder. I can see each day it's getting harder for me to walk."

Baugh can no longer feel her legs or feet, a side effect she believes of denture paste poisoning.

Complaints and lawsuits from consumers like Baugh prompted GlaxoSmithKline to voluntarily quit making and supplying vendors with the Super PoliGrip brand until it can be reformulated without zinc.

Zinc is also an ingredient in Procter & Gamble's Fixodent.

In a statement to News 8, an FDA spokesperson now admits they are "working with other manufacturers so they can address the risk as well."

"We are considering the need for a new classification regulation for denture adhesives containing zinc," the statement read.

A new FDA classification could mean safety trials for the products, which is not currently required.

"They're finally realizing that this is causing serious health problems," said Baugh, who is now permanently disabled.

Dozens of lawsuits have now been filed against Procter & Gamble and GlaxoSmithKline for denture paste poisoning.

 

FDA STATEMENT TO NEWS 8:

FDA became concerned about the potential for zinc overload in early 2009. At that point, we began assembling the facts and developing means to address the risk.

We worked with the two major producers of denture adhesives. We conveyed our concerns and the basis of those concerns.

GSK developed their recent actions, as contained in their press release, in response to our concerns and business forces.

We agree with GSK's action in that it does address the risk to health.

We are working with other manufacturers so they can address the risk as well.

In the long term, we are considering the need for a new classification regulation for denture adhesives containing zinc.

Dick Thompson

FDA Office of Public Affairs

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