The government is warning that amalgam—the silver colored dental fillings which contain mercury—may pose a safety concern for pregnant women and young children. The Food and Drug Administration (FDA) posted this precaution on its Website earlier this month, following the settlement of a lawsuit. The warning is aimed at the two groups, which are already urged to limit mercury from seafood over concerns that too much mercury can harm a developing brain. The FDA posting reads that dental amalgams, “contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.” The FDA is also determining if the mercury vapor released when chewing and brushing can also cause neurologic disorders or other problems in young children.
This spring, the FDA alerted dentists that it is considering additional controls, which include requiring warnings to alert consumers of the mercury in amalgams before having cavities filled or restricting mercury-containing amalgam fillings in small children and certain other patients. The FDA is accepting public comments until July 28 with a final ruling expected a year later, by July 28, 2009, all imposed as part of the legal settlement. “It’s an open question what we will do,” FDA Deputy Commissioner Randall Lutter told The Associated Press; however, “what this says is there’s a clear intent on our part on labeling for sensitive subpopulations.” “It’s a watershed moment,” said Michael Bender of the Mercury Policy Project, who—with other advocacy groups—sued the FDA in hopes of forcing restrictions on amalgams.
Amalgams cost about $100 versus about $150 or more for tooth-colored composites. Amalgam fillings are about 50 percent mercury and are alloyed with silver, copper, and tin and are made by mixing liquid mercury with powdered ingredients. This all requires safety steps and filters to limit waste seeping back into the environment. Used since the 1800s, amalgams’ popularity is dropping, in part due to concerns over mercury, accounting for about 30 percent of US fillings. Several other countries limit amalgams, either as a precaution in pregnant women and small children or because of environmental concern.
As part of the settlement with several consumer advocacy groups, the FDA agreed to alert consumers about the potential risks on its website and to issue a more specific rule next year for fillings that contain mercury, FDA spokeswoman Peper Long said. Such a rule could impact makers of metal fillings, which include Dentsply International Inc and Danaher Corp unit Kerr. The new rule allows the FDA to utilize “special controls (that) can provide reasonable assurance of the safety and effectiveness of the product,” Long added.
While the FDA previously said various studies showed no harm from mercury fillings, some consumer groups contend the fillings can trigger a range of health problems such as multiple sclerosis and Alzheimer’s disease. In 2006, an FDA advisory panel of outside experts said most people would not be harmed by them, but said the FDA required more information.
Mercury has long been linked to brain and kidney damage at certain levels.
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