FDA Update: Recommendations About the Use of Dental Amalgam

The FDA has recently been made aware of potential adverse health effects of mercury exposure with the use of dental amalgam to certain groups. This is due to the mercury vapor (gas) released from the dental amalgam fillings. These groups include:

• Pregnant women and their developing fetuses;
• Women who are planning to become pregnant;
• Nursing women and their newborns and infants;
• Children, especially those younger than six years of age;
• People with pre-existing neurological disease;
• People with impaired kidney function;
• People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam

The FDA recommends, if you are an individual in one of these groups, that alternative, non-mercury materials such as composite resins or glass ionomer cements be used when possible and appropriate as well as:

• Be aware the durability of any tooth restoration (filling) depends on many factors besides dental filling material. To help your teeth and fillings last as long as possible, you should maintain a healthy diet, proper oral hygiene, and regular dental checkups.
• You should discuss treatment options, including the associated benefits and risks of using dental amalgam or an alternative non-mercury filling material, with your dentist. View the FDA’s informational brochure for patients and talk with your dentist if you have additional questions.

Mercury is a known toxicant to the nervous system and long-term exposure to high mercury doses can lead to signs or symptoms such as:

• Mood disorders
• Sleep difficulties or disturbances
• Fatigue
• Memory troubles or disturbances
• Tremors
• Difficulties with coordination
• Visual changes
• Changes in hearing
• Kidney damage

Included in this update are recommendations for Dental Health Care Providers about the use of dental amalgam as well as the use of dental amalgam versus resin-based composites. The FDA encourages consumers, if you have had an allergic or other reaction with relation to dental amalgam, to report the problem through the MedWatch Voluntary Reporting Program. 

To read the full update, please visit the FDA’s website.

For any questions about this update or about reporting adverse events to the FDA, please email mdi Consultants at [email protected] RE: MedWatch.