FDA says mercury fillings are safe
Retracts warning for some patients
WASHINGTON - The Food and Drug Administration said yesterday that silver-colored dental fillings that contain mercury are safe for patients, reversing an earlier caution against their use in certain patients, including pregnant women and children.
“While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients,’’ the FDA said, citing an agency review of roughly 200 scientific studies.
Still, in final regulations issued yesterday as part of an earlier legal settlement, it said the fillings were now considered “moderate risk’’ devices and will include details about the risks and benefits of the products. They will also carry warnings against their use in patients with mercury allergies or in poorly ventilated areas.
Millions of Americans have such fillings to patch cavities in their teeth, and the FDA said it does not recommend patients have them removed. The fillings, also known as amalgams, are a combination of other metals and mercury, which at certain levels has been linked to brain and kidney damage.
In 2006, Moms Against Mercury and three other groups sued the FDA to have mercury fillings removed from the US market. Later that year, an FDA panel of outside experts said most people would not be harmed but that more information was needed.
Mercury - whether in dental, vaccines, fish, or other products - has generated much controversy. Some consumer groups contend the fillings can trigger a range of health problems such as multiple sclerosis and Alzheimer’s disease.
Part of the problem is that while much is known about high exposures to heavy metals, questions remain about “what is happening at chronic low-level exposure over a lifetime,’’ said Urvashi Rangan, the director of technical policy for Consumer Reports, whose group was not part of the initial lawsuit.
But Susan Runner, acting director for the FDA division that oversees dental devices, said there is no “causal link’’ between amalgam fillings and health problems.
“The best available scientific evidence supports the conclusion that patients with dental amalgam fillings are not at risk,’’ she told reporters.