Over-The-Counter Medications in Pregnancy

Aka: Over-The-Counter Medications in Pregnancy, OTC Medications in Pregnancy, Herbals in Pregnancy

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II. 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

III. Preparations: Upper Respiratory Medications

  1. See Upper Respiratory Medications in Pregnancy
  2. First-generation Antihistamines (Sedating Antihistamines)
    1. Diphenhydramine (Benadryl)
      1. FDA Category B
      2. Crosses placenta
      3. Risk of Oxytocin-like effects at high dose
    2. Brompheniramine
      1. FDA Category C
    3. Chlorpheniramine
      1. FDA Category C
      2. Considered as a first-choice Sedating Antihistamine in pregnancy
    4. Pheniramine
      1. FDA Category C
  3. Second-generation Antihistamines (Non-Sedating Antihistamines)
    1. Cetirizine (Zyrtec)
      1. FDA Category B
    2. Loratadine (Claritin)
      1. FDA Category B
    3. Fexofenadine (Allegra)
      1. FDA Category C
  4. Decongestants
    1. Phenylephrine
      1. FDA Category C
      2. Crosses placenta (avoid in first trimester)
    2. Pseudoephedrine
      1. FDA Category C
      2. Associated with Gastroschisis, small Intestinal Atresia and hemifacial microsomia (avoid in first trimester)
  5. Expectorants
    1. Guaifenesin
      1. FDA Category C
      2. No safety data available (avoid in first trimester)
  6. Cough Suppressants
    1. Dextromethorphan
      1. FDA Category C

IV. Preparations: Analgesics and antipyretics

  1. Acetaminophen
    1. Crosses the placenta
    2. FDA Category B (first-choice agent)
  2. Aspirin
    1. Crosses the placenta
    2. Avoid in pregnancy overall unless specifically indicated (e.g. Preeclampsia Prevention)
    3. FDA Category C in first and second trimester
    4. FDA Category D in third trimester (avoid)
  3. NSAIDS (Naproxen, Ibuprofen)
    1. Crosses the placenta
    2. Avoid in first trimester due to risk of orofacial clefts (Naproxen), cardiac defects and Transposition of the Great Vessels
    3. FDA Category C in first and second trimester
    4. FDA Category D in third trimester (avoid due to premature ductus arteriosus closure and oligohydramnios risk)

V. Preparations: Gastrointestinal medications

  1. Antacids
    1. Cimetidine (Tagamet)
      1. FDA Category B
      2. Crosses the placenta
      3. Weak Androgenic Activity in animal studies
      4. Zantac may be preferred for longerterm use
    2. Famotidine (Pepcid)
      1. FDA Category B (based on limited human data)
      2. Crosses the placenta
    3. Nizatidine (Axid)
      1. Crosses the placenta
      2. Avoid in pregnancy
      3. Risk of IUGR, fetal death and abortion seen in rabbit studies
    4. Ranitidine (Zantac)
      1. FDA Category B
      2. Crosses the placenta
    5. Proton Pump Inhibitors
      1. Crosses the placenta
      2. FDA Category B as a class including Esomeprazole (Nexium), Rabeprazole (Aciphex) and Lansoprazole (Prevacide)
      3. FDA Category C for Omeprazole (Prilosec) based on animal studies
        1. However, appears safe in pregnancy and is best studied of the PPI agents
    6. Aluminum hydroxide
      1. Pregnancy risk class is unknown, but appears safe in pregnancy
      2. Neurotoxicity risk at high dose
    7. Calcium Carbonate
      1. Pregnancy risk class is unknown, but appears safe in pregnancy
      2. First choice agent of the Antacids in pregnancy
      3. Crosses the placenta
      4. Risk of Milk-Alkali Syndrome at high dose
    8. Magnesium Hydroxide (or Magnesium carbonate)
      1. Pregnancy risk class is unknown, but appears safe in pregnancy
  2. Anti-gas agents
    1. Simethicone
      1. FDA Category B
      2. Not absorbed and does not cross the placenta, so considered safe in pregnancy
  3. Anti-Diarrheals
    1. Bismuth Subsalicylate (Pepto-Bismol)
      1. FDA Category C
      2. Avoid in pregnancy (especially second and third trimester due to Aspirin component)
    2. Loperamide (Imodium)
      1. FDA Category C
      2. Possible associations with cardiovascular defects
  4. Laxatives
    1. Mineral Oil
      1. FDA Category C
      2. Not absorbed (and does not cross the placenta)
      3. Avoid in pregnancy
      4. Risk of fat soluble Vitamin Decreased absorption (risk of neonatal Coagulopathy and bleeding complications)
    2. Castor Oil
      1. FDA Category X (absolutely contraindicated in pregnancy)
      2. Avoid in pregnancy due to risks to both mother and child
    3. Polyethylene Glycol 3350 (Miralax)
      1. FDA Category C
      2. Preferred Laxative for Constipation in Pregnancy

VI. Preparations: Herbals

  1. Herbal agents that appear safe in pregnancy
    1. Echinacea
    2. Glucosamine
      1. Used for Joint Pain
    3. Ginger
      1. Appears effective for Morning Sickness
      2. Appears safe in pregnancy
        1. Early reports of Spontaneous Abortion and Preterm Labor were not found in larger trials
  2. Herbal agents that may result in Miscarriage via uterine stimulation (avoid)
    1. Mugwort
    2. Blue Cohosh
    3. Black Cohosh
    4. Goldenseal
    5. Juniper berry
    6. Chaste berry
    7. Rue
    8. Pennyroyal oil
  3. Herbal agents that are considered unsafe in pregnancy (avoid)
    1. St. John's Wort
      1. Lack of safety data
    2. Feverfew
      1. Inhibits Platelet aggregation
      2. Inhibits prostglandin production
    3. Ephedra
      1. Anencephaly risk
      2. Transposition of the Great Vessels risk
      3. Aortic Stenosis risk

VII. Preparations: Topical Dermatologic Preparations

  1. Topical Antifungal agents
    1. Topical Imidazoles (Miconazole, Clotrimazole)
      1. Absorption varies depending on concentration
      2. Well studied and appear safe in pregnancy
    2. Topical Nystatin
      1. Minimal absorption
      2. Well studied and appears safe in pregnancy
    3. Topical Terbinafine (Lamisil)
      1. Topical Terbinafine has not been studied, but oral Terbinafine is FDA Catetegory B
  2. Topical Corticosteroids
    1. Hydrocortisone 1%
      1. Absorption varies to a maximum of 7%
      2. Appears safe in pregnancy, but limit to smallest area of needed application, and shortest duration of use
  3. Topical Antibiotics
    1. Topical Bacitracin
      1. Appears safe in pregnancy
  4. Topical acne agents
    1. Topical Benzoyl Peroxide
      1. Appears safe in pregnancy (despite low levels of absorption up to 5%)

VIII. References

  1. Briggs (2008) Drugs in Pregnancy and Lactation, Lippincott Williams and Wilkins, Philadelphia, PA
  2. Servey (2014) Am Fam Physician 90(8): 548-55 [PubMed]

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