Pregnancy Drug Labeling Could Lead to Inconsistent Decisions, ASHP Warns FDA

9/17/2008

ASHP recently voiced its concern that proposed changes to the Food and Drug Administration (FDA) requirements for pregnancy and lactation prescription medication labeling fail to create a consistent and useful format for medical decision-making and could compromise patient safety.

The Society recently submitted comments on the FDA’s proposed rule on pregnancy and lactation medication labeling. The rule would eliminate pregnancy categories A, B, C, D, and X, which identify risks of reproductive and developmental adverse effects from medication use. Under the rule, the labels would require a fetal risk summary and statement about the background risk of fetal developmental abnormalities, among other requirements, according to the proposed rule.

ASHP recommended the FDA not eliminate the categories and should develop a clinically-tested, standardized schema to represent the risk continuum in pregnancy and lactation medication labeling. The Society noted that without standardized labeling requirements, the private sector could conduct narrative discussions about risk and develop a wide array of schema and rules to support pregnancy risk decisions for patient medication use that are not useful. Such discussions could lead to differing interpretations of risk assessment.

ASHP also encouraged the agency to include pharmacists in focus groups before implementing new regulations for pregnancy and lactation labeling. Previous groups did not include pharmacists.

Click here to read ASHP’s letter.