Approximately 35 million people use denture adhesives called denture creams, typically when they wake up and after they eat. Ingestion of denture cream is a known cause of zinc-induced copper deficiency resulting in neurological problems. Zinc is very common and an important dietary requirement. Humans typically ingest between eight and eleven milligrams per day (often through red meat, nuts and grains).
However, lawsuits alleging zinc toxicity of denture creams are showcasing how too much of a good thing can be harmful. Some consumers who used denture cream were exposed to at least 330 milligrams of zinc daily, far more than the recommended daily intake of 40 milligrams.
Denture creams 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.
Zinc in denture cream is absorbed through the gums. High levels of zinc inhibit copper absorption, which can cause a copper deficiency and anemia. It can also reduce the function of the immune system. One of the most disabling side effects of zinc poisoning are called “neuropathies.” There are more than 100 different kinds of neuropathy, although peripheral neuropathy is the most common form. According to The Neuropathy Association, peripheral neuropathy is “the result of damage caused to the nerves, which disrupts the body’s ability to communicate with its muscles, skin, joints, or internal organs.” Symptoms include numbness or tingling in the extremities, abnormal sensations, foot pain, loss of balance, and inability to hold objects.
Though reducing zinc intake to normal levels can help, oftentimes the damage is not reversible, and there is no cure. Victims injured by denture cream may have extensive medical and other needs, which they cannot afford on their own.
There are several lawsuits filed against GlaxoSmithKline and Proctor and Gamble for their denture cream products–Poligrip and Fixodent. The lawsuits allege that the denture cream manufacturers failed to warn consumers about the risks of zinc toxicity.
“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).”