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*÷ºÎ 2

Updated 12/31/2002
FDA Consumer Update: Dental Amalgams

FDA and other organizations of the U.S. Public Health Service
(USPHS) continue to investigate the safety of amalgams used in dental
restorations (fillings). However, no valid scientific evidence has shown
that amalgams cause harm to patients with dental restorations, except
in the rare case of allergy.

The safety of dental amalgams has been reviewed extensively over the
past ten years, both nationally and internationally. In 1994, an
international conference of health officials concluded there is no
scientific evidence that dental amalgam presents a significant health
hazard to the general population, although a small number of patients
had mild, temporary allergic reactions. The World Health Organization
(WHO), in its Consensus Statement on Dental Amalgam reached a
similar conclusion. They wrote: "Amalgam restorations are safe and
cost-effective¡¦Components in dental restorative materials, including
amalgam, may, in rare instances, result in local side-effects or allergic
reactions. The risk of adverse side-effects is very low for all types of
restorative materials, including amalgam and all resin-based materials.¡±
Similar conclusions were reached by the USPHS, the European
Commission, the National Board of Health and Welfare in Sweden, the
New Zealand Ministry of Health, Health Canada and the province of
Quebec.

In January 1993, the USPHS published a broad scientific report about
the safety and use of dental amalgam and other materials commonly
used to fill dental cavities. USPHS reaffirmed these conclusions in 1995
and 1997. Since then, the National Institutes of Health (NIH), the
Centers for Disease Control and Prevention (CDC), and the Food and
Drug Administration (FDA) have continued to study the issue. The
National Institute of Dental & Craniofacial Research at NIH has also
provided money to study the safety of dental amalgams and to develop
non-mercury alternatives. This effort includes research and clinical
studies of dental amalgam use in children. These studies are ongoing
and will require several years of follow-up in order to detect any subtle
and long-range health effects.

Also, USPHS scientists analyzed approximately 175 peer-reviewed
studies submitted in support of three citizen petitions received by FDA
after the 1993 report. The USPHS concluded that data in these studies
did not support claims that individuals with dental amalgam restorations
will experience problems, including neurologic, renal or developmental
effects, except for rare allergic or hypersensitivity reactions.

Although there is international agreement that the scientific data do not
confirm the presence of a significant health hazard, several countries
restrict the use of dental amalgams or have recommended limitations on
their use. For example, Health Canada recommended that dental
amalgam be avoided in people allergic to mercury or with impaired
kidney function; if possible, to avoid its placement or removal in the
teeth of pregnant women; and to consider the use of alternatives in the
primary teeth of children. Some manufacturers now include these
"contraindications" (against using) in their labeling of dental amalgams
sold in those countries. If a manufacturer wishes to make a similar
labeling change in its dental amalgam sold in the United States, FDA
will require the manufacturer to submit a new marketing application
with data supporting the change.

FDA is examining its regulation of dental amalgam alloy, and
pre-encapsulated dental amalgam. To reduce possible allergic reactions
from restorative materials, FDA is proposing in labeling guidance that
the product's labeling list the ingredients in descending order of weight
by percentage and include lot numbers, appropriate warnings and
precautions, handling instructions and expiration dating. The labeling
guidance will be most useful with new restorative materials.

While research, regulatory changes, and educational efforts are
underway, the use of dental amalgams in the U.S. is declining. Pediatric
dentists, in particular, are using resin (plastic) FDA cleared
tooth-colored materials that are bonded to the tooth. They may release
fluoride and are mercury-free. Other reasons for the decline in amalgam
use include increasing use of sealants and community fluoridation, an
expanding selection of fluoride-containing dental products, improved oral
hygiene practices, and greater access to dental care. With the
improvement of alternative restorative materials over the past few
years, dentists increased their use of these products.

The USPHS will continue to gather data about possible risks of dental
amalgams and other restorative products and to pursue new methods of
dental treatment and oral health. As an important part of this plan,
USPHS will continue working with the dental profession to bring about
changes in the delivery of oral healthcare based on valid scientific
research.

=====================

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