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Medications in Pregnancy

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Medications in Pregnancy, FDA Pregnancy Categories

  • Background
  1. Pregnancy Categories will be replaced on medication bottles with specific warnings and precautions by 2020 in U.S.
    1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm
    2. Although FDA Pregnancy Categories are no longer listed, they are included here
      1. As of 2018, succinct guidance (to replace ABCDX) on specific drugs in pregnancy is lacking
  • Approach
  • General Recommendations
  1. Avoid medications if possible in first trimester
  2. Limit use to safe, short-acting, non-combination drugs
  3. Topical medications are preferred over systemic agents
  4. Use the lowest effective dose of a medication
  5. Birth defects occur in 3% of pregnancies even without Teratogen Exposure
  6. Balance medication benefits versus risks in pregnancy
    1. Untreated serious conditions (e.g. Asthma, Seizure disorder, Diabetes Mellitus) are associated with birth defects
    2. Uncontrolled Diabetes Mellitus with Hemoglobin A1C of 10% is associated with a birth defect risk up to 25%
  7. References
    1. (2018) Presc Lett 25(10): 56
  • Preparations
  • Class A
  1. No risk in controlled human studies
  2. Examples
    1. Acetaminophen (Tylenol)
    2. Pyridoxine (Vitamin B6)
  • Preparations
  • Class B
  1. No risk in controlled animal studies
  2. Examples
    1. Amoxicillin
    2. Cephalosporin antibiotics
  • Preparations
  • Class C
  1. Small risk in controlled animal studies
  2. Examples
    1. Codeine
    2. Dicloxacillin
  • Preparations
  • Class D
  1. Strong evidence of risk to the human fetus
  2. Examples
    1. Coumadin
    2. Valium
  • Preparations
  • Class X (Never to be used in Pregnancy)
  1. Very high risk to the human fetus
  2. Examples
    1. Xanax
    2. Accutane
  • Resources
  1. CDC Medications in Pregnancy
    1. http://www.cdc.gov/pregnancy/meds/index.html
  2. Vaccines and Medications in Pregnancy Surveillance System (VAMPSS)
    1. http://www.aaaai.org/about-the-aaaai/strategic-relationships/vampss/vampss-consumer.aspx
  3. MotherToBaby Fact Sheets (from Organization of Teratology Information Specialists or OTIS)
    1. http://www.mothertobaby.org/fact-sheets-s13037
  • References
  1. Briggs (1998) Drugs in Pregnancy and Lactation, 5th ed
  2. Larimore (2000) Prim Care 27(1):35-53 [PubMed]