The FDA announced earlier this year that they will be reviewing dental amalgam yet again for its safety, mostly in pregnant women, fetuses, and young children. Several citizen petitions for the FDA’s reconsideration of dental amalgam have prompted this review. In July 2009, amalgam was reclassified by the FDA from a Class I substance to Class II, meaning it was given a status of “more risk.” In the past, many studies have been done to prove amalgam’s safety. The available studies, however, only show that dental amalgam does not cause adverse health effects in adults and children over the age of six. Since not much information is available on younger children, fetuses, and pregnant women, the FDA has chosen to conduct this study. As dental professionals it is important that we are aware of the most up to date information in the ongoing discussion of dental amalgam. It is our job, of course, to provide the best care for our patients, but also to educate them on the scientific facts. Thus far dental amalgam has been proven a safe and effective restorative material, and we will all wait with anticipation for the FDA’s decision on its safety in these more vulnerable populations.
The links below provide more information on the upcoming FDA review of dental amalgam:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm215061.htm
Also, below are several journal articles listed in the FDA’s Appendix I : Summary of Changes to the Classification of Dental Amalgam and Mercury reporting the results from clinical trials on the safety of amalgam in adults and children over age of six.
De Rouen, T. et al., “Neurobehavioral Effects of Dental Amalgam in Children, A Randomized Clinical Trial,” Journal of the American Medical Association, Vol. 295, 1784-1792,No. 15, April, 19, 2006.
Bellinger, D.C. et al., “Neuropsychological and Renal Effects of Dental Amalgam in Children: A Randomized Clinical Trial,” Journal of the American Medical Association, Vol. 295, No. 15, April 19, 2006, 1775-1783, 2006.
Barregard, L. et al., “Renal Effects of Dental Amalgam in Children: The New England Children’s Amalgam Trial,” Environmental Health Perspectives, Volume 116, 394-399,,No. 3, March 2008.
Woods, J.S. et al., “Biomarkers of Kidney Integrity in Children and Adolescents with Dental Amalgam Mercury Exposure: Findings from the Casa Pia Children’s Amalgam Trial,” Environmental Research, Vol. 108, pp. 393-399, 2008.
Lauterbach, M. et al., “Neurological Outcomes in Children with and Without Amalgam-Related Mercury Exposure: Seven Years of Longitudinal Observations in a Randomized Trial,” Journal of the American Dental Association, Vol. 139, 138-145, February 2008.
~Sara Twardy, Alabama ’11, Editor-in-Chief
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