FDA Wants New Drug Classification System for Pregnant Women

May 2008

Women and their doctors may soon be better informed about the safety of drugs that are taken during pregnancy and breastfeeding. The U.S. Food and Drug Administration (FDA) has proposed a new system for classifying drugs that will provide more detailed information about a medication’s health risks.

Pregnant women take an average of three to five medications during pregnancy and more than 90 percent of women take drugs during the first week after delivery while they are nursing. Experts say that many doctors and patients find the current drug classification system confusing and do not understand that drugs in the same class may have different safety risks. The FDA says that under the newly proposed system, drug labels would provide comprehensive information about the risks of a medication to a woman and her child during pregnancy and breastfeeding.

The FDA has been working on the proposal since 1997. The new system would also call for companies to keep drug labels up to date. Although drug manufacturers are currently required to update their labels about newly discovered adverse side effects and health risks, the companies do not have to notify the FDA if they learn drugs are safer than once thought. This can prevent doctors from prescribing drugs to their patients.