Denture Cream Poisoning in The NEWS

An estimated 35 million people use denture adhesives, especially when they wake up and after they eat.

But now, another North Texas man claims it poisoned him and he said he believes others may also unknowingly be exposed to danger in a tube.

Gerald Elliott, of Ellis County, can barely walk on his own.

"The problem with my feet is they're almost totally dead," he said. "I [can] hardly feel."

Elliott makes his way through his small cabin by grabbing onto the walls.

"I'm able to hold on to everything, I've got a post here and there almost like a chimpanzee," he said.

After years of increasing discomfort and declining health, Elliott went to the doctor and was diagnosed with neuropathy: nerve damage.

"And [the doctor] diagnosed me with zinc toxicity; and I didn't believe it," he said.

But a second opinion confirmed it.

After months of ruling out other factors, medical records showed high levels of zinc in his system attributed to SuperPoligrip.

He's not alone.

Last year, News 8 profiled JD Jackson, who said he also suffered neuropathy linked to zinc toxicity from Super PoliGrip.

News 8 learned of at least two lawsuits filed against GlaxoSmithKline, the makers of Super PoliGrip, for the same problem. At least one of those suits was settled out of court with a confidentiality agreement.

Denture cremes were approved more than 30 years ago as a "Class 1 medical device" according to a statement by the FDA. Class 1 medical devices are considered low-risk and are not required to list the ingredients on the label.

Denture adhesives also come with no warning.

GlaxoSmithKline admitted zinc is one of SuperPoligrip's primary ingredients. In a statement, GSK said the risk of zinc poisoning is "minimal" when the product is "used as directed."

But Baylor College of Dentistry Dr. Charles Wakefield said the vast majority of people who use over-the-counter denture creams do so because they have poorly fitting dentures, which often means they use much more product than recommended.

"And for those people, that's exactly correct, and there's a huge market for that," Dr. Wakefield said.

Dr. Wakefield said the mouth's membranes absorb minerals and medicines better than anywhere else in the body. So, it's entirely possible that many people are soaking in more zinc through their gums than they should.

"Sure it's all possible," said Dr. Wakefield when asked if possible zinc poisoning has been mistaken for something else. "But, what needs to be done is a really good, thorough, well-controlled study needs to be done to rule it in or out."

Since discontinuing use of Super PoliGrip, Elliott claimed his zinc levels have returned to normal; but the effects are permanent.

"I'm just a common ol' boy, but it was hard for me to believe that something that simple could cause so much damage," he said.

He's suing the company. He said his ultimate isn't to punish the company, but warn other denture wearers of a potential risk.

FDA Statement

"The U.S. Food and Drug Administration (FDA) regulates denture adhesives, which are medical devices under the Food, Drug and Cosmetic Act. A denture adhesive is a device intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort. FDA has classified this product as a low-risk device (class I). While manufacturers are not required to submit marketing applications to FDA for most class I devices, they still must register and list a class I device with the agency and comply with other applicable FDA requirements. These requirements include adverse event reporting, manufacturing controls, and labeling that is neither false nor misleading. FDA monitors adverse events from medical devices through mandatory and voluntary reporting systems. Manufacturers and hospitals are required by law to report deaths and serious injuries. Manufacturers also must report malfunctions that could result in death or serious injury. FDA reviews reports submitted to the agency and has authority to take immediate action, when warranted, to protect public health. Consumers can report problems experienced with any product to FDA either by phone (800-FDA-1088), fax (800-FDA-0178), on-line (www.fda.gov) or mail (MedWatch, The FDA Safety Information and Adverse Event Reporting Program, FDA, 5600 Fishers Lane, Rockville, MD 20852)."

Statement from GlaxoSmithKline Consumer Healthcare

"GlaxoSmithKline Consumer Healthcare stands by the safety and efficacy of Super Poligrip®, which is approved and regulated by the Food and Drug Administration (FDA). Although we can't comment on this person's claim, we want to assure consumers that Super Poligrip is safe and effective when used as directed. When someone uses Super Poligrip for their dentures, the vast majority of the zinc in the product remains in the adhesive and is not released into the mouth. Thus the potential for absorption of zinc through the gums is minimal. Although it is expected that a small amount of Super Poligrip would be swallowed when used as directed, the amount of zinc that is released into the stomach and absorbed into the bloodstream is very small. Therefore, the possibility of experiencing adverse effects from exposure to zinc in Super Poligrip is highly unlikely when the product is used as directed. Zinc is an essential mineral that is found in almost every cell in the body and in foods like red meat, poultry, whole grains and beans and is necessary for the maintenance of good health and nutrition. Zinc is a very common ingredient in many over- the- counter and FDA approved products."