Facing scores of lawsuits from consumers who say denture adhesive caused them serious health problems, the maker of Super Poligrip announced Thursday that it will stop making and distributing all its denture products that contain zinc.
The manufacturer, GlaxoSmithKline, also warned consumers of the "potential health risks associated with long-term excessive use" of the products, which may include numbness, tingling or weakness in the arms and legs, difficulties with walking and balance and anemia.
The action follows medical studies correlating zinc in denture products with neurological damage, and news reports such as one in Monday's St. Petersburg Times.
Glaxo spokeswoman Malesia Dunn said that retailers can sell current stocks of Super Poligrip Original, Ultra Fresh and Extra Care but that reformulated zinc-free versions should be available by late April or early May.
The company already makes three products that do not contain zinc: Super Poligrip Free, Powder and Comfort Seal Strips. It says products with zinc are safe when used as directed, but it acknowledged some consumers use more than recommended.
The advisory says consumers who use more than the amount directed should stop using it and talk to their doctors. Dunn said that although the action was voluntary, the company consulted the U.S. Food and Drug Administration, which regulates denture adhesives. "They were in agreement with our action," Dunn said.
It's up to stores to decide whether to sell the three products. Walgreens will continue to do so, company spokesman Robert Elfinger said, noting the retailer was assured the products are safe when properly used.
Though zinc is an essential mineral, chronic high usage can deplete the body's stores of copper, leading to neurologic disease. A 2008 study by the University of Texas Southwestern Medical Center examined patients with various neurological problems and traced the cause to their use of products such as Super Poligrip and Fixodent.
Zinc helps with adhesion. Although well-fitting dentures require little or no adhesive, wearers who have poor fit can require a lot of adhesive, even two or three tubes a week.
More than 100 lawsuits have been filed across the country against GlaxoSmithKline and Procter & Gamble (makers of Fixodent), including more than 70 in Miami. The suits allege the companies failed to warn consumers of zinc's hazards. Neither firm listed zinc, which was approved for use in adhesives by the FDA 15 years ago, on their labels until after the 2008 study.
Ed Blizzard, a Miami lawyer who has filed several suits, called the announcement "a responsible action for GSK to take and a victory for consumers," but said it came years too late.
Blizzard represents the family of Rodney Urbanek, a longtime Miami resident who died in 2008 in South Carolina at age 64 of respiratory distress syndrome, linked to neurological problems caused by longtime use of Super Poligrip.
Urbanek's wife, Gisela, said she was pleased with Thursday's announcement.
"That is wonderful," she said from her home in Little River, S.C. "Of course, it's too late for my husband and for me, but I'm very happy that at least other people are not going to go through what my husband went through."
Procter & Gamble, maker of Fixodent, did not return calls.
Though none of the lawsuits is believed to involve any Tampa Bay residents, more than 100 people contacted the Times in response to Monday's story. Most reported having similar neurological problems to those mentioned in the story.
Larry Raes, 61, of Seminole, has worn dentures for the past four to five years and uses Super Poligrip two or three times a day to help keep them in place — package directions say it should be used once a day. Last summer, his legs "started feeling weak and rubbery," he said.
His doctor attributed the problem to his weight. "But I know it's not my weight. I've been 228 pounds for the last 10 years," said Raes, who is 5 feet 9.
Raes said he plans to see his doctor to find out if denture adhesive might be the cause.
Richard Martin can be reached at [email protected] or (727) 893-8330.