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FDA issues rule on prescription drug labels

May 18, 2015

by Michelle Manchir

A final rule from the U.S. Food and Drug Administration that sets new standards for information regarding risks and benefits for drugs and biological products used during pregnancy and breastfeeding goes into effect on June 30.

The new rule applies to all new drug and biological product applications approved by the FDA as of June 30 and thereafter gradually to previously approved products subject to the Physician Labeling Rule.

The rule will likely result in increased access to information for health care providers, including dentists, who prescribe drugs or biological products to pregnant or breastfeeding women.

The new rule requires the use of subsections in the label titled “Pregnancy,” “Lactation” and “Females and Males of Reproductive Potential.” Within the subsections, manufacturers must include a summary of the risks of using a drug during pregnancy and breastfeeding, a discussion of the data supporting the summary and relevant information to help health care providers make prescribing and counseling decisions, according to the FDA.

Pregnant women take an average of three to five prescription drugs during pregnancy, according to the FDA, and there are over six million pregnancies in the U.S. every year.

The ADA urges all pregnant women and women of child-bearing age to have regular dental examinations. The ADA acknowledges that preventive, diagnostic and restorative dental treatment to promote health and eliminate disease is safe throughout pregnancy and is effective in improving and maintaining the oral health of the mother and her child.

Dentists can refer patients who are pregnant to ADA’s consumer website,, for information about how to maintain oral health during pregnancy.

More information about the new FDA guidelines can be found at by searching for “pregnancy labeling information.”