The maker of Poligrip denture cream will stop making formulas containing zinc amid lawsuits claiming years of excessive use caused neurological damage and blood problems in consumers, allegedly crippling some.
GlaxoSmithKline will stop making and marketing Super Poligrip Original, Ultra Fresh and Extra Care products in the U.S. The company plans to reformulate the creams without zinc.
The company, based in London, reported more than $520 million in denture adhesive sales last year.
It stressed that the products are safe when used as directed, but that some people use extra cream to correct ill-fitting dentures.
Glaxo's voluntary action comes as hundreds of lawsuits are poised to go to trial, alleging Poligrip caused nerve damage, leading to a loss of balance, loss of sensation in the hands and feet, and leaving some patients paralyzed.
"They made the right decision in the sense that it's going to prevent the crippling of more people," said attorney Andy Alonso of Parker Waichman Alonso LLP. "But it's too late for many of my clients."
Alonso represents more than a hundred users of denture cream in Miami federal court, where several hundred lawsuits are being consolidated. The plaintiffs say the makers of zinc-based creams failed to warn consumers about potential risks.
Alonso estimates about 30 million people in the U.S. wear dentures and use products like Poligrip.
There are currently 75 denture cream cases consolidated before Miami U.S. District Judge Cecilia M. Altonaga, who will decide whether to choose a few for trial that would act as bellwethers for the rest, said plaintiffs' attorney Scott Weinstein. The Glaxo decision would have limited impact due to rules against using a company's actions to fix a problem in suits claiming previous damages, he said.
Altonaga's next hearing is set for March 23.
One of the lawsuit plaintiffs, 62-year-old Ronald Beaver of Tamarac, Fla., used PoliGrip for years before he began feeling weak and developed a blood disorder four years ago. He's now able to work only two days a week at his moving company job and feels "run down" much of the time.
Told of GlaxoSmithKline's decision on zinc products, Beaver said he was "shocked" because the company had consistently denied any problems in the past.
"It's like a complete admission. They went from outright denial to a complete admission," Beaver said.
Lawyers suing Glaxo said the company's decision will put pressure on other makers of zinc-containing denture cream, most notably Procter & Gamble, which makes Fixodent.
A spokeswoman for Cincinnati-based P&G said the company has no plans to reformulate its product.
"The levels of zinc in Fixodent are approximately half of what's used in Super Poligrip," said Michelle Vaeth. She added that the amount of zinc in Fixodent is equal to that found in a hamburger.
Both Glaxo and P&G market zinc-free alternatives to their products.
Federal health experts recommend 8 milligrams of zinc per day for women and 11 milligrams for men. The right amount of zinc helps the body fight off illnesses and also promotes cell growth.
Attorney Ed Blizzard, who represents several dozen plaintiffs, said Poligrip contains 38 milligrams of zinc per ounce.
Although one tube is meant to last 8 to 10 weeks, Blizzard says some of his patients were using a tube of Poligrip a week, giving them about 45 times the recommended dose of zinc.
Blizzard is encouraged by Glaxo's decision to phase out the product, but he says it's no indication the company plans to settle the lawsuits.
Denture creams containing zinc were first approved by the FDA more than 15 years ago, and the agency has never issued a safety warning on the products, according to industry group Consumer Healthcare Products Association.
Zinc is believed to help with adhesion. But in 2008 researchers at the University of Texas Southwestern Medical Center in Dallas described a possible link between denture cream zinc and nerve damage.
The researchers noted that excessive zinc can purge the body of copper, a chemical needed for normal brain and nervous system function.
A copper deficiency can cause anemia, as well as weakness and numbness in arms and legs; difficulty walking and loss of balance; and eventually permanent paralysis.
"Our typical Super Poligrip and Fixodent client uses a wheelchair, walker or cane for mobility and many of them have hands so spastic that they resemble claws," said Eric Chaffin, a partner with Chaffin Luhana, which represents several dozen patients.
Glaxo and P&G only began disclosing the zinc in their products after the University of Texas' findings were published in a medical journal.
AP Writer Curt Anderson reported from Miami
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