Pregnant Women, Children Cautioned on Dental Mercury (Update1)
By Avram Goldstein

June 5 (Bloomberg) -- The mercury in dental fillings may have toxic effects on fetuses and young children, U.S. regulators said for the first time as part of a legal settlement.

After decades of debate about the safety of mercury amalgam dental fillings, the Food and Drug Administration added the statement on ``safety concerns'' to its Web site this week, said agency spokeswoman Peper Long in a telephone interview today. The FDA agreed to post the warning about the dangers for developing human brains to settle a lawsuit by a collection of environmental groups, consumers and state officials.

In the settlement, the FDA agreed to bring to a conclusion by July 2009 a regulatory review of mercury in fillings that began in 2002. The process could result in a requirement that prescribing information warn dentists and pregnant women of nervous system dangers to fetuses and young children with developing brains, Long said.

``Gone are all of FDA's claims that no science exists that amalgam is unsafe,'' said Michael Bender of Vermont, a plaintiff in the lawsuit, in a statement today on PR Newswire. ``The 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.''

Mercury is a neurotoxin that can interfere with brain growth and has been shown to affect cognitive and motor-skill development, according to the Environmental Protection Agency.

Dental Association

The American Dental Association, the largest group of U.S. dentists, said the settlement amounts to little because it doesn't change the current use of mercury. Cavities are filled with the amalgam, made of mercury and a powder containing silver, tin, copper, zinc and other metals. Dentists have used it for more than 100 years.

``Dental amalgam remains a safe, affordable and durable cavity-filling choice for dental patients,'' the dental group said in a statement today on PR Newswire. That belief, the group said, is based on ``extensive studies and scientific reviews of dental amalgam by government and independent organizations worldwide.''

An FDA panel of independent advisers voted 13 to 7 in 2006 to reject the agency's conclusion that the available literature supports continued use of mercury in fillings. The agency had said it reviewed 34 studies and found no evidence the metal releases harmful mercury vapors in the mouth from chewing or during dental procedures.

Data Sought

Many members of the panel, which included doctors and dentists, said the risks associated with mercury fillings can't be quantified without better data on short-term exposure and certain patient groups. About 30 percent of the more than 150 million fillings placed in the U.S. each year are made of amalgam.

Patient advocates urged the panel to recommend that the FDA ban amalgam in favor of tooth-colored composite resins, which they said are safer and just as effective.

Dentists argued that fillings containing mercury are stronger, cheaper and more durable, and said the amount of mercury exposure from fillings is minuscule when compared with fish and other dietary sources.

The lawsuit was filed in December in U.S. District Court in Washington and then assigned by a federal trial judge to a magistrate who served as a mediator, Long said. FDA officials added the cautionary language to the agency Web site on June 3 with ``uncharacteristic speed,'' Bender said.

The case is: Moms Against Mercury v. Eschenbach, 07cv2332, U.S. District Court for the District of Columbia.