II. Background
- Pregnancy Categories will be replaced on medication bottles with specific warnings and precautions by 2020 in U.S.
- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm
- Although FDA Pregnancy Categories are no longer FDA designated, they are included here
- As of 2018, succinct guidance (to replace ABCDX) on specific drugs in pregnancy is lacking
III. Class B: No risk in controlled animal studies
- Antifungal Topical Agents
-
Antiparasitic Agents
- Metronidazole or Flagyl (after first Trimester)
- Short-term use after first trimester appears safe
- Avoid single dose therapy (high dose)
- Avoid long-term use (due to fetal malformation associations)
- Praziquantel - not in Briggs
- Permethrin (topical) - not in Briggs (1998)
- Metronidazole or Flagyl (after first Trimester)
- Anti-Tuberculosis agents
- Ethambutol
- Didanosine - not in Briggs (1998)
-
Antiviral Agents
- Nelfinavir - not in Briggs (1998)
- Ritonavir
- Saquinavir
- Famciclovir
- Valacyclovir
-
Antibiotics
- All CephalosporinAntibiotics (except Moxalactam)
- All Erythromycin except Erythromycin Estolate
- All PenicillinAntibiotics
- Clindamycin
- Macrodantin (before 36 weeks)
- Sulfa Antibiotics (second trimester only)
IV. Class C: Small risk in controlled animal studies
-
Antifungal agents
- CDC recommends only Topical Antifungal in pregnancy
- Avoid Antifungals in first trimester if possible
- Terbinafine (Lamisil) - not in Briggs (1998)
- Clotrimazole (Mycelex, Lotrimin)
- Butoconazole (Femstat)
- Miconazole (Monistat)
- Amphotericin B
- Fluconazole (Diflucan)
- As of 2016, evidence of Miscarriage risk, with even 1-2 doses
- No fetal adverse effects seen in one study
- Itraconazole (Sporanox)
- Ketoconazole (Nizoral)
- Griseofulvin
- CDC recommends only Topical Antifungal in pregnancy
- Antimalarial agents
-
Antiparasitic Agents
- Albendazole - not in Briggs (1998)
- Ivermectin - not in Briggs (1998)
- Mebendazole
- Pentamidine
- Thiabendazole
- Pyrantel
- Anti-Tuberculosis agents
- Antiviral Agents
-
Antibiotics
- Imipenem-Cilastin
- All FluoroquinoloneAntibiotics (avoid in pregnancy due to cartilage damage risk)
- Macrolides in general (including Azithromycin)
- May increase heart defects with first trimester exposure of 5-7 days
- Previously only Clarithromycin was considered a potential Teratogen (Cleft Lip association)
- Fan (2020) BMJ 368: m331 +PMID:32075790 [PubMed]
- Pediazole - not in Briggs (1998)
- Sulfisoxazole - not in Briggs (1998)
- Trimethoprim (Folic Acid Antagonist)
- Vancomycin
- Chloramphenicol
- Gentamicin
V. Class D: Strong evidence of risk to the human fetus
-
Antiparasitic Agents
- Metronidazole or Flagyl (First Trimester)
- Brief use may be safe in first trimester
- Burtin (1995) Am J Obstet Gynecol 172:525-9 [PubMed]
- Metronidazole or Flagyl (First Trimester)
-
Antibiotics
- Amikacin (Class D per manufacturer)
- Kanamycin
- Streptomycin
- Tobramycin (Class D per manufacturer)
- Sulfa (Third Trimester)
- All Tetracycline Antibiotics
- Tetracycline
- Minocycline
- Doxycycline
- Does not appear to have same adverse effects as other Tetracyclines
- May be considered in serious infections without good alternatives (e.g. Rocky Mountain Spotted Fever)
- Erythromycin Estolate (llosone)
- Due to hepatotoxicity in pregnant women
- McCormack (1977) Antimicrob Agents Chemother 12:630 [PubMed]
- Macrobid and Nitrofurantoin (Third Trimester)
- Do not use either of these past 36 weeks
- Can cause Hemolytic Anemia in newborns
- Related to immature liver and G6PD Deficiency
- Vaccines
VI. Class X: Very high risk to the human fetus
- Antimalarial agents
-
Antiviral Agents
- Ribavirin
- Rebetron - not in Briggs (1998)
-
Vaccines
- MeaslesVaccine
- Mumps Vaccine
- RubellaVaccine
- Small PoxVaccine
- TC-83 Venezuelan Equine EncephalitisVaccine
- Varicella Vaccine
- Risk if vaccinated within 4 weeks of conception
- Theoretic risk only; not an indication for EAB
VII. References
- (2017) Presc Lett 24(5): 26
- Briggs (1998) Drugs in Pregnancy and Lactation, 5th ed
- Black (2003) Am Fam Physician 67(12):2517-24 [PubMed]
- Larimore (2000) Prim Care 27(1):35-53 [PubMed]