What is it with GSK’s dodgy products?
Why do they produce so many defective products?
and why do so many of them cause neurological damage?
Poligrip denture zinc ingredients ‘to be removed amid health fears for pensioners’
The ingredients of the popular denture glue, Poligrip, are to be removed from production amid fears it is damaging the health of millions of pensioners worldwide.
GlaxoSmithKline, the British pharmaceuticals giant, announced on Thursday that it was removing zinc from its denture adhesives after claims that “long-term, excessive” use of the products was bad for people’s health.
It has been claimed that long-term use of popular brands such as Poligrip Ultra and Poligrip Total Care has been linked to neurological damage.
It comes as hundreds of lawsuits in America 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 paralysed.
The company, which said it was a precautionary and voluntary decision, said the products were safe when used as directed.
It warned that some people used extra cream to correct ill-fitting dentures and urged customers who have done so to seek medical advice.15 Feb 2010
For example, a 40g tube of the adhesive should last up to six weeks, but because of their ill fitting dentures applied it more regularly.
Zinc only enters the body when swallowed and is not absorbed in the mouth.
The company, which is reformulating all of its adhesive products to be zinc-free – which will be clearly labelled on packaging – sold about £336m ($US525m) worth of denture adhesive products last year.
When asked if Glaxo’s move was a response to that litigation, Jo Revill, a company spokeswoman replied: “We’re doing this as a precautionary measure to minimise the risk to consumers.”
Earlier in a statement, Dr Howard Marsh, chief medical officer of GSK Consumer Healthcare, said the company last year received an increased number of “adverse event reports”.
“It is important for consumers to know that Poligrip Ultra and Poligrip Total Care remain safe to use as directed on the product label,” he said.
“We are taking this voluntary action because we have become aware of potential health problems associated with the long-term excessive use of our zinc-containing denture adhesive products.
“These reports are very rare, given that several million people worldwide are users of the products.”
He added: “If anyone is concerned that they may have been using the product in excess they should stop using it, talk to their doctor and switch to a zinc-free alternative.”
The company added: “Together with published literature, these suggest that excessive use of these products, typically for several years, may lead to the development of high levels of zinc in the body which are associated with neurological symptoms such as numbness, tingling or weakness in the arms and legs, difficulties with walking and balance and blood problems such as anaemia.”
Procter & Gamble said it does not plan any changes to the formula for Fixodent, a competing adhesive.
“The levels of zinc in Fixodent are half that used in Super Poligrip,” said company spokeswoman Michelle Vaeth.
“Fixodent formulations have been safely marketed for 20 years.”
Ms Vaeth said the amount of zinc a consumer would ingest from normal daily use of Fixodent is less than the amount of zinc in most daily multivitamins and comparable to the zinc in six ounces of ground beef.
Researchers at the University of Texas first raised the possibility of a link between denture cream and nerve damage two years ago.
August 2, 2010 — GlaxoSmithKline (GSK) plans to settle “the vast majority” of several hundred lawsuits that allege consumers suffered zinc poisoning and neurological disabilities after using GSK Super Poligrip denture adhesives.
“With respect to the Poligrip product liability litigation, the Group has reached agreement in principle to settle the vast majority of cases,” the company stated on page 26 of a 36-page summary of its second-quarter financial results, released July 21.
When contacted by DrBicuspid.com, GSK declined to comment further at this time because ongoing litigation is involved. The company did not disclose the number of Super Poligrip lawsuits settled or the amount of money GSK will pay as part of the settlement.
Hundreds of lawsuits have been filed against GSK and Procter & Gamble (which manufactures Fixodent) by individuals who claim they suffered zinc poisoning and neurological injuries after using the products. The lawsuits allege that the manufacturers:
- Failed to inform consumers that the denture creams contain zinc
- Failed to warn consumers about the potential health risks if too much of the adhesive is consumed
GSK has contended that the products are safe when used as directed, but that some consumers apply more adhesive than directed and use it more than once per day.
Even so, the company announced earlier this year that it would stop manufacturing the Poligrip products and replace them with zinc-free alternatives. In an advisory issued February 18, the company warned consumers about the potential health risks associated with long-term excessive use of zinc-containing denture adhesives, including Super Poligrip Original, Super Poligrip Ultra Fresh, and Super Poligrip Extra Care.
And in March the company announced that it would recall all zinc-containing Poliggrip products currently on the Japanese market.
On July 27, a motion was filed in federal court to establish a fund to satisfy claims involving some of the Poligrip lawsuit clients while the allocation and final disbursement of the monies is finalized, according to a story on aboutlawsuits.com.