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Entries in Denture Cream (2)

Monday
Feb282011

FDA Urges Removal of Zinc from Denture Creams, Citing Nerve Damage Studies

Photo Courtesy - Getty Images(WASHINGTON) -- After receiving more than 360 complaints that long-term overuse of the popular denture cream Fixodent caused serious nerve damage, the Food and Drug Administration last week urged denture cream makers to remove zinc, modify package labels and conduct further research of risks.

As ABC News reported earlier this month, excessive long-term use of zinc-containing denture creams like Fixodent may cause serious and irreversible neurological damage. Poligrip, the other leading denture cream, no longer contains zinc.

An exclusive ABC News investigation also uncovered that a paid consultant to Proctor & Gamble, maker of Fixodent, did not disclose a possible conflict of interest when he peer-reviewed a scientific study of four patients that suggested a link between an overuse of denture cream containing zinc and nerve disease.

In a Notice and Recommendation Action dated Feb. 23, 2011, the FDA wrote: "Although zinc is an essential nutrient, overexposure may result in zinc toxicity. We are notifying all manufacturers of denture adhesives and asking for their assistance in dealing with this public health issue."

Consumers most at risk are those "using excessive amounts of the products over extended periods of time; people with poor fitting dentures; and people who are unable to read or understand product labeling," the FDA wrote.

It "strongly recommends" manufacturers of denture creams that contain zinc, including Fixodent, to consider "replacing zinc with an ingredient that presents less health risks in situations of overuse."

Proctor & Gamble on Monday told ABC News that it is in active discussions with the FDA on this topic, that it takes the recent notice very seriously, and that it is "carefully considering the FDA's recommended actions."

The company also mentioned that it has already changed its product label to caution customers about overuse of the product, and said it is "always looking for new and improved formulas as we strive to improve our products."

Copyright 2011 ABC News Radio

Tuesday
Feb082011

Can Excessive Use of Fixodent Cause Nerve Damage?

Photo Courtesy - Getty Images(NEW YORK) -- A study released in 2009 suggested that the prolonged use of the denture cream Fixodent could cause significant nerve damage.  Now, a class-action suit including two patients, Anne Coffman and Mark Jacoby, has been filed against Procter & Gamble, makers of Fixodent, alleging that their use of the product has caused their devastating problems.  Both Coffman and Jacoby say they must use wheelchairs due to the debilitating neurological illness.

"I don't know if you can put a dollar value on my health or anybody else's, for that matter," Coffman told Cuomo. "I would prefer to see [the makers] take the zinc right out of the product...or take the product right off the market."

Used by many of the 35 million Americans who wear dentures, the cream is marketed with the catchy tagline "Fixodent -- and forget it." But what the maker didn't tell consumers for years was that the adhesive contains zinc, which when ingested or absorbed in large amounts over time can lead to serious nerve damage.

The possible connection first was made five years ago by researchers at the University of Texas, who studied four denture users with neurological disease.

"They had high zinc levels that we could measure in the blood," said Dr. Sharon Nations, author of a study in the journal Neurology. "And all of them reported that they were using very large amounts of denture cream."

That study was completed in 2006, but its publication in Neurology was delayed for more than two years. It was delayed, according to its authors, because of a peer review by Dr. Kenneth Shay, a dentist, who lambasted the study and called the link between excessive use of denture cream and neurological disease "little more than speculation." He said that the authors "don't understand the nature of the material they are writing about."

But an ABC News investigation found that Shay at the time also was a paid consultant for Procter & Gamble, the maker of Fixodent, when he reviewed the study. In e-mails and documents obtained by ABC News, Shay not only made recommendations that, according to the authors, led them to water down the study's finding, but also sent draft reports of the study to Procter & Gamble.

It wasn't until 2009, after the study was published in the journal Neurology, that Procter & Gamble added a "new label information" warning to the side of Fixodent packages, and on the back, cautioned that "prolonged zinc intake may be linked to adverse health effects."

Shay declined to be interviewed, but in a phone call with ABC News he defended his review of the study, saying that the research report had "objective shortcomings."

Procter & Gamble sent a written statement to ABC News reading:

"Procter & Gamble is committed to providing safe and effective products for all consumers. That is who we are and what we stand for. We go to great lengths to ensure that our products safely deliver best-in-class performance, so consumers can choose our products with total confidence. Fixodent is safe for use as directed, as supported by the experience of millions of consumers over many years. Our Fixodent formula has undergone extensive scientific testing, and we continuously monitor for its safe use. ... We know of no valid scientific evidence that using Fixodent as directed causes any ill health effects."

But Mark Jacoby and others like him said it all comes too late. He has stopped using Fixodent, but said the damage to his body has been done.

"Fixodent and forget it?" said Jacoby. "Well, apparently I can't forget it 'cause it took a lot away from me."

Copyright 2011 ABC News Radio







ABC News Radio