WASHINGTON, July 29 — Dental fillings that contain mercury are safe, but have been upgraded from low-risk to moderate-risk devices, the FDA said.

In its final rule on dental amalgam, the FDA recommended that product labeling include warnings against use in patients with mercury allergy and that dental professionals use adequate ventilation when handling the product.

The label should also have a statement about the product’s benefits and risks — including those from inhaling mercury vapor, the agency said.

The FDA’s action is the latest development in a long and contentious battle involving the agency, the American dental establishment, and a variety of consumer and environmental groups who argue that mercury-based amalgam fillings are potentially harmful.

The rule was originally proposed in 2002 but received a large number of comments and was investigated further.

A 2006 advisory committee meeting of dental and neurology experts asked that the FDA probe deeper into the scientific literature on dental amalgam before making a final rule. Consumer groups eventually filed a lawsuit to compel the agency to act.

Throughout its review, the agency said it considered 200 scientific studies, reflected in the final rule issued today.

The consumer groups who originally sued the agency expressed anger at the ruling, saying the agency reneged on promises to require tougher warnings about mercury-based amalgam, particularly involving children and pregnant women.

“FDA broke its contract and broke its word that it would put warnings for children and unborn children,” Charles Brown of Consumers for Dental Choice, told the Associated Press. He pledged to go back to court.

Dental amalgam is 50% liquid elemental mercury and 50% powdered metals including silver, tin, and copper.

The FDA considers dental amalgam fillings safe for adults and children age 6 and up. The agency says the amount of mercury in patients with dental amalgam fillings is well below levels associated with adverse health effects.

Dental amalgam is a “pre-amendment device,” meaning it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices.

That law required the FDA to issue regulations classifying pre-amendment devices according to their risk into class I, II, or III.

Amalgam fillings are now Class II devices. Most fillings today are made of a composite of material that matches the color of tooth enamel, but many dentists say that for some applications, amalgam is still the material of choice.

The agency had previously classified the two separate parts of amalgam but had not issued a separate regulation classifying the combination of the two.

The American Pharmacists Association (APhA) advises consumers to take acetaminophen products as recommended on the labeling and seek guidance from pharmacists or other healthcare providers on evaluating medication options. This recommendation comes as the gov/” rel=”nofollow”>Food and Drug Administration (FDA) convened a public advisory committee meeting on June 29 and June 30, 2009 regarding acetaminophen use in both over-the-counter (OTC) and prescription (Rx) products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury.

The committee recommended a range of options for the FDA to consider from putting warning labels on products to pulling certain medicines from the market. The FDA will take the recommendations into consideration before taking any action and is not obligated to follow the recommendations of the advisory committee.

“Acetaminophen is an effective, long utilized medication in relieving patient pain and fever, and is considered safe when used according to the directions on product labeling,” said Ed Hamilton, PharmD, FAPhA, and APhA President. “As the FDA considers the recommendations made by the committee, we urge consumers not to panic, but to take acetaminophen containing products and any other medicines as directed by the product label or prescription label. Consumers are also encouraged to ask questions. Pharmacists are here to answer consumers questions about medications and can help them identify which ones may have acetaminophen.”

What should consumers do?

- If taking acetaminophen containing products (commonly referred to as Tylenol® or APAP), always take according to current directions and dosing instructions.

- Healthy adults should not exceed 4 grams (4000mg) of acetaminophen per day. Others should seek advice from their pharmacist or other health care provider for appropriate dosing limits.

- Always read OTC and Rx medication labels before each use, follow the directions, and if you have questions, ask the pharmacist or other health care provider.

- If a dosing device is included with a specific medication, use only that device for that medication.

- Check the active ingredients of OTC and Rx medications to ensure that multiple products do not contain acetaminophen. Generally, taking multiple products containing acetaminophen is not advisable due to the risk of exceeding the maximum daily dose and liver damage.

- Store all medications appropriately, keep all medications out of the reach of children, and always return medications to a proper storage location following each use.

- Seek medical advice immediately if you or someone you know may have taken too much acetaminophen.

- Advise your health care providers of all Rx, OTC, herbal and dietary supplement products taken regularly or on an as needed basis.

Source
American Pharmacists Association (APhA)