Poligrip with Zinc Recalled In Japan. Why Not U.S.?Mar 8, 2010 | Parker Waichman LLP
Following drug maker, GlaxoSmithKline’s, announcement last month that it is no longer making, distributing, or issuing advertisements for its Super Poligrip with zinc, a recall has been issued in Japan, said WFAA. Now, many are wondering why a similar recall is not taking place in the United States and why a complete recall has not been initiated.
We just wrote that the American Dental Association (ADA) issued a statement regarding the health risks associated with zinc-containing denture creams. The ADA statement followed GlaxoSmithKline’s announcement it would voluntarily stop making, distributing, and advertising its Super Poligrip denture creams that contain zinc.
While the human body does need zinc, the mineral is only needed in small amounts. Studies show that consuming at least 50 milligrams of zinc daily for a few months could lead to copper deficiency, which can cause anemia, bone loss, nerve damage, and other problems. Ingesting 80 or 100 milligrams or more for months or even years can lead to irreversible damage.
Compelling and established evidence exists that long-term exposure to the zinc in denture cream can lead to not only irreversible nerve damage, but to disability, as well. In August 2008, the peer reviewed journal Neurology reported on four patients suffering from neuropathy and other neurological symptoms typical of zinc poisoning and copper depletion. The article specifically linked excess zinc in denture cream to “profound neurologic disease” in the patients reviewed.
A GlaxoSmithKline spokesman confirmed the drug maker issued the voluntary recall in Japan, saying that the product has not been recalled outside of Japan because it is safe when used as directed, said WFAA. According to the drug maker, it recently posted a video online that shows consumers how to appropriately use Super Poligrip with zinc; for instance, the video explains, "Do not apply more than once a day without your dentist's advice." To many, these measures are not sufficient given the significantly dangerous outcomes linked to zinc ingestion.
Glaxo has admitted that customers with ill-fitting dentures tend to overuse the dental cream, which sometimes causes them to swallow the excess, which is then absorbed by the body, including zinc, said WFAA. Meanwhile, although the firm has admitted that overuse of dental cream is not uncommon, that such use can result in behaviors that can result in zinc absorption, and that too much zinc can lead to serious health complications, Glaxo has only agreed to an oversees recall.
Glaxo has said it will reformulate Super Poligrip so that future versions will not contain zinc, said WFAA, adding that stores will not restock shelves with the already-manufactured zinc-containing product. The drug maker also wrote to 200,000 doctors and dentists in the United States, advising them about the possible health risks of zinc-containing denture cream and providing a telephone number to report possible cases of denture cream poisoning.
GlaxoSmithKline’s zinc-containing denture cream products—Super Poligrip “Original,” “Ultra Fresh,” and “Extra Care”—will be reformulated, with new zinc-free varieties expected to be available this spring. Despite this, none of these products is being recalled in the United States and those currently in stores continue to remain available for sale.