Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit.
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.
Millions of Americans have the fillings, or amalgams, to patch cavities in their teeth.
“Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses,” the FDA said in a notice on its Web site.
“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 agency said.
The FDA said it did not recommend that people who currently have mercury fillings get them removed.
The FDA must issue the new rules in July 2009, Long said.
Such a rule could impact makers of metal fillings, which include Dentsply International Inc and Danaher Corp unit Kerr.
The new rule will give the agency “special controls (that) can provide reasonable assurance of the safety and effectiveness of the product,” Long said.
The lawsuit settlement was reached on Monday with several advocacy groups, including Moms Against Mercury, which had sought to have mercury fillings removed from the U.S. market.
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 agency needed more information.
Mercury has been linked to brain and kidney damage at certain levels. Amalgams contain half mercury and half a combination of other metals.
Charles Brown, a lawyer for one of the groups called Consumers for Dental Choice, said the agency’s move represented an about-face. “Gone, gone, gone are all of FDA’s claims that no science exists that amalgam is unsafe,” he said in a statement.
J.P. Morgan Securities Inc. analyst Ipsita Smolinski said the FDA is not likely to outright ban the fillings next year but will probably call for restrictions.
“We do believe that the agency will ask for the label to indicate that mercury is an ingredient in the filling, and that special populations should be exempt from such fillings, such as: nursing women, pregnant women, young children, and immunocompromised individuals,” Smolinski wrote in a research note on Wednesday.
Fewer patients have been opting for mercury fillings in recent years, instead choosing lighter options such as tooth-colored resin composites.
Only 30 percent of fillings given to patients were mercury-filled ones as of 2003, according to the American Dental Association (ADA). Other options include glass cement and porcelain as well as other metals such as gold, but they cost more and are less durable, the group has said.
By Susan Heavey