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 listed, they are included here
- As of 2018, succinct guidance (to replace ABCDX) on specific drugs in pregnancy is lacking
III. Approach: General Recommendations
- Avoid medications if possible in first trimester
- Limit use to safe, short-acting, non-combination drugs
- Some OTC Medications may be used safely in any trimester (but avoid overuse, esp. in first trimester)
- Topical Medications are preferred over systemic agents
- Use the lowest effective dose of a medication
- Birth defects occur in 3% of pregnancies even without Teratogen Exposure
- Balance medication benefits versus risks in pregnancy
- Untreated serious conditions (e.g. Asthma, Seizure Disorder, Diabetes Mellitus) are associated with birth defects
- Uncontrolled Diabetes Mellitus with Hemoglobin A1C of 10% is associated with a birth defect risk up to 25%
- References
- (2018) Presc Lett 25(10): 56
IV. Preparations: Class A
- No risk in controlled human studies
- Examples
V. Preparations: Class B
- No risk in controlled animal studies
- Examples
VI. Preparations: Class C
- Small risk in controlled animal studies
- Examples
VIII. Preparations: Class X (Never to be used in Pregnancy)
IX. Resources
- CDC Medications in Pregnancy
- Vaccines and Medications in Pregnancy Surveillance System (VAMPSS)
- MotherToBaby Fact Sheets (from Organization of Teratology Information Specialists or OTIS)
X. References
- Briggs (1998) Drugs in Pregnancy and Lactation, 5th ed
- Larimore (2000) Prim Care 27(1):35-53 [PubMed]