Download Pregnancy Categories and Prescribing Practices

Medication Use During Pregnancy
Medication use in pregnancy is complicated by the risk of harm to the fetus. To guide the physician
in the decision making process, the FDA created categories to assess the fetal risk when medications
must be used by during pregnancy. Since high-quality randomized controlled clinical trials are lacking in
this area, information in each category is based on case reports and conventional knowledge.
Pregnancy Risk Factor Categories:
 Category A
o Controlled studies show no risk of fetal abnormalities in humans.
 Category B
o No adequate evidence in humans and animal trials have demonstrated no risk of harm to
the fetus or animal studies have shown an adverse effect but human trials have failed to
demonstrate risk.
 Category C
o Animal studies have shown adverse fetal effects or there are no adequate and well
controlled studies in humans therefore the drug should be used only if the benefit
outweighs the risk.
 Category D
o Clear evidence of risk in humans however benefits may outweigh the risks.
 Category X
o Contraindicated in pregnancy.
Medications that are generally considered safe to use in pregnancy:
Acetaminophen (Tylenol®)
Amoxicillin and Augmentin®
Calcium Carbonate (Tums®)
Docusate (Colace®)
Folic Acid
H2 antagonists
Medications you may encounter in family medicine which may cause harm to the fetus:
o ACE-inhibitors (X)
o Anticonvulsants: Phenytoin,
o Coumadin (X)
Valproic Acid (D)
o HMG-CoA reductase
o Retinoids (X)
inhibitors (“statins”) (X)
o Tetracyclines (D)
o Live vaccines: varicella,
o Ergotamine (X)
MMR, Small-pox (X)
o Contraceptives (D or X)
Remember: The risk of harm for the fetus is generally greatest during the first trimester. If your
patient desires to become pregnant and is taking a medication that is likely to harm the fetus, switch
your patient to an alternative agent that is considered safe during pregnancy.
**These categories are for pregnancy only and should not be considered when managing a patient
who has questions regarding medication use while breastfeeding.
Erin Cantrell PharmD Candidate 2011 Ohio Northern University and Stephanie Gibson, PharmD, BCPS
Medications in Pregnancy:Weighing the Risks vs. Benefits of Treatment Options, Volume II. Walgreens Health Initiative. Available from
http://www.MyWalgreensCE.com
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 6 th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2002.