FDA changes stance on dental amalgam
WHITE OAK, Md., U.S.: The U.S. Food and Drug Administration (FDA) has updated its guidance for the use of dental amalgam in tooth restorations. The agency said in September that the use of dental amalgam should be avoided whenever possible in certain groups, such as in pregnant women, women who are planning to become pregnant, in children and in people with certain preexisting neurological diseases.
The use of dental amalgam has remained widespread in the U.S., despite its use being phased out or banned in certain groups in a number of countries. Until its recent announcement, the FDA had considered dental amalgam restorations to be safe for adults and children over the age of 6.
As detailed in its September statement, the FDA’s new position on the use of dental amalgam is that its use may pose a greater risk for potential harmful health effects for certain groups, and it therefore recommends that its use in these groups be avoided “whenever possible and appropriate”.
These groups are:
pregnant women and their developing fetuses;
women who are planning to become pregnant;
nursing women and their newborns and infants;
children, especially those younger than 6 years of age;
people with preexisting neurological disease such as multiple sclerosis, Alzheimer’s disease and Parkinson’s disease;
people with impaired kidney function; and
people with known heightened sensitivity (allergy) to mercury or other components of dental amalgam.
As pointed out by Multiple Sclerosis News Today, the agency has not banned the use of dental amalgam, or explicitly stated that it should not be used, but has updated its guidance and published a new information brochure on its use and removal in tooth restorations. The FDA does not recommend the removal or replacement of dental amalgam restorations that are in good condition.
The agency’s brochure states that “studies on people with dental amalgam do not show conclusive evidence that dental amalgam causes harmful health effects in the general population.”
It has been argued within the international medical and scientific community that there is evidence of a causal link between the use of dental amalgam in tooth restorations and the incidence of neurological conditions such as multiple sclerosis. The International Academy of Oral Medicine & Toxicology has compiled a summary of research related to mercury exposure and the incidence of multiple sclerosis, and this can be accessed together with additional resources on the academy’s website.
Dental Tribune International reported in May that 9,287 pounds (4,212 kg) of mercury was used for dental amalgam in the U.S. in 2018. According to the U.S. Environmental Protection Agency, this accounted for 46.8% of the total elemental mercury that was used to make products in the country in that year.