FDA Advisors Find Holes in Report on Dental Fillings

Government health advisors Thursday rejected a federal report that concluded dental fillings used by millions of patients are safe, saying further study of the mercury-laden amalgam is needed.

A joint panel of Food and Drug Administration advisors did not declare the so-called silver fillings unsafe. But in a 13-7 vote Thursday, the advisors said the federal report did not objectively and clearly present the current state of knowledge about the fillings.

In a second 13-7 vote, the panelists said the report’s conclusions about safety were not reasonable, given the quantity and quality of information available.

The FDA had asked the panel of outside advisors to weigh the report, a review of 34 recent research studies.

The report had found “no significant new information” that would change the FDA’s earlier determination that mercury-based fillings don’t harm patients, except in rare cases where they have allergic reactions.

“For the general population, amalgams are safe. There is evidence of that,” said Dr. Karl Kieburtz, a University of Rochester professor and chairman of one of the two panels. Still, Kieburtz and other panelists said remaining uncertainties about the risk the fillings may pose to some groups demanded further study.

In particular, they said, research is needed on the effect of dental mercury on children; on the fetuses of pregnant women with fillings; and on others whose bodies may absorb, distribute, process and eliminate mercury differently.

“There are too many things we don’t know, too many things that were excluded,” said Michael Aschner, a professor of pediatrics and pharmacology at Vanderbilt University and a panel consultant. He cast two “no” votes.

Panelists also said more study was needed on whether mercury fillings give off more vapors when they are being placed or removed.