Food and Drug Administration pregnancy categories

Category	Animal studies	Human data	Benefit may outweigh risk
A	Negative*	Studies^¶ negative	Yes
B	Negative	Studies not done	Yes
B	Positive^Δ	Studies negative	Yes
C	Positive	Studies not done	Yes
C	Not done	Studies not done	Yes
D	Positive or negative	Studies or reports positive	Yes
X^◊	Positive	Studies or reports positive	No

In 2015, the US Food & Drug Administration (FDA) began overseeing the phase-out of pregnancy risk categories (A, B, C, D, and X) from prescription drug labeling and began requiring information from available human and animal studies of (1) known or potential maternal or fetal adverse reactions, and (2) dose adjustments needed during pregnancy and the postpartum period. Additional information is available at the FDA website: Pregnancy and Lactation Labeling Final Rule.

* No teratogenicity demonstrated
¶ Adequate and well-controlled studies in pregnant women (Fed Reg 1979; 44:37461)
Δ Teratogenicity demonstrated
◊ Drug is contraindicated in pregnancy

Reproduced with permission from: Schatz M, Hoffman CP, Zeiger RS, et al. The course and management of asthma and allergic diseases during pregnancy. In: Allergy: Principles and Practice, Middleton E, Reed CE, Ellis EF, et al (Eds), St. Louis, Mosby, 1998. Copyright © 1998 Mosby.

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Food and Drug Administration pregnancy categories