Following the settlement of a lawsuit earlier this week, the US Food and Drug Administration (FDA) has updated its consumer advice on mercury amalgam to say that it poses health risks to pregnant women, children, and the unborn.
The updated consumer advice, which is in the FDA’s Center for Devices and Radiological Health (CDRH) section of the website (web address given at the end of this article), now states that:
“Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetus.”
“Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner.”
The update follows a lawsuit brought against the FDA by a team of four non profit groups (including Moms against Mercury), two public officials, three dental experts, and two consumers describing themselves as “victims”. One of the plaintiffs, mercury expert Michael Bender, said in a statement issued via PR Newswire in Washington yesterday, 5th June, that:
“After 32 years of delay, the Food and Drug Administration has finally agreed to comply with the law and set a date to classify mercury amalgam as a substance that poses a health risk to pregnant women and unborn babies, and children.”
“The FDA must now finish classification within one year of the close of the public comment period on its amalgam policy, that is, by July 28, 2009,” added Bender.
Bender said the federal regulator has now distanced itself from previous claims that “no science exists that amalgam is unsafe”, or that its own advisory panel said two years ago that it was safe, and that other countries acted for “environmental reasons only”.
Instead, said Bender:
“FDA has moved to a more neutral course, while still recognizing the serious health risks posed by amalgam in particular for children and unborn children, for pregnant women, and for those with mercury immuno-sensitivity.”
In addition to drawing conclusions as a joint committee when they met in September 2006, members of the FDA’s advisory panel on mercury and amalgam issued personal statements that said, among other things, the agency should consider introducing a practice of informed consent for patients receiving amalgam, and that the labelling should be changed to restrict use of amalgam in pregnant women and children.
According to an editorial in the Journal of the American Medical Association in April 2006 (an issue that also contained a report on controlled trials of amalgam), dental amalgam contains at least 50 per cent mercury by weight and has been used for the last 150 years. The mercury from the amalgam (used in fillings) enters the bloodstream, and a “number of investigations suggest that this has toxic consequences”.
Sources: FDA, PR Newswire, JAMA April 2006.
Written by: Catharine Paddock, PhD