Regulators eye link between denture cream
and zinc toxicity
Regulatory authorities and dental
associations are examining reports that overuse of zinc-based denture adhesives
may cause neurological damage. While a direct causal link has not yet been
established, dentists are being advised to counsel denture-wearing patients to
ensure they aren't using too much adhesive.
The issue has been percolating for several
years, but received renewed attention this month following a segment that
appeared May 5 on "Good Morning America." In addition, the U.S. FDA
has received adverse event reports claiming that cases of zinc toxicity were
caused by denture cream overuse, and the agency has confirmed that it has
formed a working group to examine the issue.
At issue is the effect that excessive
ingestion of zinc over a long period of time can have in depleting the amount
of copper in the human body, as copper deficiency can lead to the impairment of
various neurological processes. In fact, copper deficiency is a
well-established and increasingly recognized cause of neurologic and
hematologic disease, and excess zinc has been identified as a source of copper
deficiency (Journal of Neurology, January 2004, Vol. 251:1, pp. 111-114).
This is where denture adhesives come in --
some, anyway. While not all denture creams contain zinc, two of the most
popular are GlaxoSmithKline's (GSK) Super PoliGrip and Procter and Gamble's
(P&G) Fixodent, both of which are zinc-based (GSK also offers a zinc-free
version of PoliGrip). The zinc acts as a binding agent that increases the
product's hold, according to Jennifer May, a spokesperson for over-the-counter
products at GSK.
While zinc is an essential mineral naturally
present in many protein-rich foods such as beef, chicken, and nuts, and many
supplements and other over-the-counter products such as Zicam (a cold
medicine), there are limits to how much a person should ingest on a daily
basis, especially with long-term use. The acceptable daily intake is 8 mg for
women and 11 mg for men, and more than 40 mg constitutes zinc poisoning,
according to the U.S. National Academy of Sciences.
A 2.4 oz (68 gram) tube of Super PoliGrip
contains 38 mg of zinc per gram of product, and GSK recommends that a single
tube should last approximately six weeks. According to the company's Web site:
You should not use more than the indicated
quantity of Super PoliGrip, or use it more often than once per day, to
compensate for poorly fitting dentures. You should consult your dentist
regularly to maintain proper-fitting dentures.
The Super PoliGrip packaging carries these
same recommendations, along with the list of ingredients (topping the list is
"poly(methylvinylether/maleic acid) sodium-magnesium-zinc mixed partial
salt").
Language on the Fixodent packaging is less
explicit; under "Helpful Hints," a highlighted section reads
"Don't use too much product at first. It may take a few tries to find the
right amount for you!" and "Consult your dentist regularly to ensure
proper fitting dentures." There is no list of ingredients on either the
Fixodent box or tube; because the FDA has classified denture cream as a Class I
device, the manufacturers are not required to list the ingredients.
However, the Fixodent Web site does feature
a letter from J. Leslie Winston, D.D.S., Ph.D., P&G's director of
professional and scientific relations for North America, which states in part:
A small amount of zinc is used in Fixodent
to provide denture hold. This helps the denture stay in place securely so our
consumers can eat, chew, and talk more confidently. All Fixodent products
undergo rigorous scientific evaluations and safety testing before appearing on
shelf and we continue to monitor them once in market. ... The average amount of
zinc an average denture adhesive user would ingest from daily usage of Fixodent
is less than the amount of zinc in most daily multivitamins and comparable to 6
ounces of ground beef.