Drug pregnancy categories

(Redirected from Drug Ratings in Pregnancy)

This categorization system has been superseded by the 2015 FDA Pregnancy and Lactation Labeling Rule

Background

  • The FDA previously assigned letter categories to medications based on their potential for risk to the fetus
  • New drugs approved after the 2015 PLLR will not be assigned a pregnancy category.

Table

Category Interpretation Details
A Human studies show no risk Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy
B No evidence of risk in studies Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
C Risk cannot be ruled out Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
D Positive evidence of risk Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.
X Contraindicated in pregnancy Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant.

Category A Drugs

Category B Drugs

Antibiotics

Other Antimicrobials

Antiemetics and other GI medications

Analgesics and other neuro/psych meds

Cardiovascular Medications

Antiplatelet and Anticoagulants

Antidotes

Miscellaneous

Category C Drugs

Includes most medications not listed elsewhere here

Category D Drugs

Antimicrobials

AEDs and other neuro/psych meds

Cardiovascular

Miscellaneous

Category X Drugs

See Also

External Links

References