Did Embarrassing Media Exposure Motivate FDA to Act on Denture Cream Zinc Poisoning?

April 13, 2011, 5:00PM. By Gordon Gibb

New York, NYIt was on February 8 that investigative reporter Chris Cuomo held up a thick sheaf of papers comprised of 360 adverse reaction reports that had been submitted to the US Food and Drug Administration (FDA) with regard to Fixodent zinc poisoning.

Cuomo had been following the Fixodent denture cream story—and the entire zinc denture cream issue. Included were allegations that a peer reviewer had succeeded in delaying the release of an important 2006 peer-reviewed study by two years. That study showed that four patients, who had used large amounts of denture cream containing zinc in an effort to rein in ill-fitting dentures, had exposed themselves to neuropathy borne from a critical imbalance of zinc and copper.

To wit, the human body requires a careful balance of copper and zinc for optimum performance. When that balance is upset—by introducing large amounts of zinc that serves to deplete levels of copper—an imbalance is present with sometimes devastating results.

Cuomo was doing a story on a man in his forties who was forced to get around his mobile home using a walker following the effects of denture cream zinc poisoning.

And so, two years after the denture cream study was completed (2006), another two years while it was allegedly held up by a peer reviewer with alleged ties to the denture cream manufacturer (2008), yet another two years had passed without any definitive position undertaken by the FDA.

Thus, Cuomo appeared with Diane Sawyer on ABC World News Tonight, waving the thick sheaf of papers in a public, if unspoken, challenge to the FDA for action.

That action finally came about two weeks later, when the FDA authored a communiqué to the manufacturers of denture cream adhesives, urging GlaxoSmithKline and Procter & Gamble to consider removing zinc from their denture cream formulations.

GlaxoSmithKline had already noted its intention to manufacture its Poligrip product without zinc, which up to now has been a preferred bonding agent considered safe when used as directed. Procter & Gamble had yet to take a similar stance with its Fixodent denture cream.

The FDA noted on February 23 that it had received "numerous reports of adverse events related to the use of denture creams" consistent with zinc toxicity. One has to wonder if Cuomo's appearance on the ABC evening news show mere weeks prior had anything to do with it.