FDA flip flops on amalgam

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Although it’s been about 18 months since they last proclaimed it safe, this week the US Food and Drug Administration (FDA) has been hearing evidence about whether amalgam fillings are safe. The new hearings have come about after four consumer advocacy organisations have mounted a challenge to the FDA’s March 2009 ruling. They cite a range of new studies that point to neurological conditions and even Alzheimer’s disease as consequences of some people’s dental work.

The organisations are asking the FDA’s dental-products panel to, at the very least, reclassify the amalgam to bar its use in pregnant women and children. The organisations, however, have stated publicly they would prefer to see the amalgam banned.

“The agency so far has taken no steps to protect this most vulnerable population,” Sylvia Dove, a member of the group Consumers for Dental Choice, told the panel yesterday.

While no new specific new evidence has emerged about the fillings’ safety or risks, FDA officials are seeking input on how the agency assessed the data and drew its conclusions for its 2009 ruling.

Anthony Watson, head of the FDA’s division that oversees dental devices, said “FDA and other agencies have tried to tackle the safety of dental amalgam for the better part of the last two decades.”

Although FDA earlier said it was not necessarily going to take new regulatory action, Watson told panelists the agency would work with their recommendation: “Obviously everybody in this room wants something to happen quickly and so do we.”

In early discussions, advisers raised questions about older scientific methods used to assess just how much mercury a patient is exposed to through their fillings. They also expressed concern that a number of the studies the FDA weighed in making its 2009 ruling were outdated.

Whatever the case, one month ago The World Health Organisation published a report – Future Use of Materials for Dental Restoration – saying that “dental amalgam remains a dental restorative material of choice, in the absence of an ideal alternative and the lack of evidence of alternatives as a better practice”.

The report was of the meeting of WHOs Oral Health Program held in Geneva last November which assessed the scientific evidence available on dental restorative materials alternative to dental amalgam and the implications to countries of using alternatives to amalgam for dental restorative care.

The report continues: “If dental amalgam were to be banned, a better and more long-lasting replacement would be needed than the materials available to date. The choice of materials may depend on the tooth, site and size of cavity, as well as healthcare financing, patient preference, health care provider preference, technology, cost and environmental factors. While the harmful effects of mercury on health and the environment are recognised, the possible adverse effects of alternative materials require further research and monitoring. Providing the best care possible to meet patients’ needs should be of paramount importance. Variations between countries and challenges faced by middle- and low-income countries are critical. Implications for training of dental personnel and costs to society as well as the individual are significant and need to be taken into consideration”.

The meeting concluded that a complete ban may not be realistic, practical and achievable. The report added: “It may be prudent to consider ‘phasing down’ instead of ‘phasing out’

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