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DRUGS IN PREGNANCY

ANTIBIOTICS IN PREGNANCY

Class B: No risk in controlled animal studies

A. Antifungal Topical Agents


1. Nystatin (Mycostatin)
B. Antiparasitic agents
1. Metronidazole or Flagyl (after first Trimester)
a. Short-term use after first trimester appears safe
b. Avoid single dose therapy (high dose)
c. Avoid long-term use (due to fetal malformation associations)
2. Praziquantel - not in Briggs
3. Permethrin (topical) - not in Briggs (1998)
C. Anti-Tuberculosis agents
1. Ethambutol
2. Didanosine - not in Briggs (1998)
D. Antiviral agents
1. Nelfinavir - not in Briggs (1998)
2. Ritonavir
3. Saquinavir
4. Famciclovir
5. Valacyclovir
E. Antibiotics
1. All Cephalosporin Antibiotics (except Moxalactam)
2. All Erythromycin except Erythromycin Estolate
3. Azithromycin (Zithromax), but not Clarithromycin (see below)
4. All Penicillin Antibiotics
5. Clindamycin
6. Macrodantin (before 36 weeks)
7. Sulfa antibiotics (second trimester only)

Class C: Small risk in controlled animal studies

A. Antifungal agents
1. CDC recommends only Topical Antifungal in pregnancy
a. Avoid Antifungals in first trimester if possible
2. Terbinafine (Lamisil) - not in Briggs (1998)
3. Clotrimazole (Mycelex, Lotrimin)
4. Butoconazole (Femstat)
5. Miconazole (Monistat)
6. Amphotericin B
7. Fluconazole (Diflucan)
a. As of 2016, evidence of Miscarriage risk, with even 1-2 doses
i. Mølgaard-Nielsen (2016) JAMA 315(1):58-67 +PMID:26746458
[PubMed]
b. No fetal adverse effects seen in one study
i. King (1998) Clin Infect Dis 27:1151-60 [PubMed]
8. Itraconazole (Sporanox)
9. Ketoconazole (Nizoral)
a. Teratogenic and Embryotoxic in animals
b. Associated with hepatotoxicity
10. Griseofulvin
a. Teratogenic and Embryotoxic in animals
B. Antimalarial agents
1. Mefloquine (Lariam)
2. Chloroquine
3. Primaquine
C. Antiparasitic agents
1. Albendazole - not in Briggs (1998)
2. Ivermectin - not in Briggs (1998)
3. Mebendazole
4. Pentamidine
5. Thiabendazole
6. Pyrantel
D. Anti-Tuberculosis agents
1. Dapsone
2. Isoniazid (INH)
3. Pyrazinamide
4. Rifampin
E. Antiviral agents
1. Lamivudine
2. Stavudine
3. Zalcitabine
4. Zidovudine
5. Delavirdine - not in Briggs (1998)
6. Nevirapine
7. Indinavir
8. Cidofovir
9. Foscarnet
10. Ganciclovir
11. Acyclovir
12. Amantadine
13. Rimantadine
14. Interferon alpha
F. Antibiotics
1. Imipenem-Cilastin
2. All Fluoroquinolone antibiotics (avoid in pregnancy due to cartilage damage risk)
3. Clarithromycin (Biaxin)
a. Contrast with Erythromycin and Azithromycin which are category B
4. Pediazole - not in Briggs (1998)
5. Sulfisoxazole - not in Briggs (1998)
6. Trimethoprim (Folic Acid antagonist)
a. May be used as part of Trimethoprim-Sulfamethoxazole (Bactrim, Septra) in
second trimester
7. Vancomycin
8. Chloramphenicol
9. Gentamicin

Class D: Strong evidence of risk to the human fetus

A. Antiparasitic agents
1. Metronidazole or Flagyl (First Trimester)
a. Brief use may be safe in first trimester
b. Burtin (1995) Am J Obstet Gynecol 172:525-9 [PubMed]
B. Antibiotics
1. Amikacin (Class D per manufacturer)
2. Kanamycin
3. Streptomycin
4. Tobramycin (Class D per manufacturer)
5. Sulfa (Third Trimester)
6. All Tetracycline antibiotics
a. Tetracycline
b. Minocycline
c. Doxycycline
i. Does not appear to have same adverse effects as other Tetracyclines
ii. May be considered in serious infections without good alternatives
(e.g. Rocky Mountain Spotted Fever)
7. Erythromycin Estolate (llosone)
a. Due to hepatotoxicity in pregnant women
b. McCormack (1977) Antimicrob Agents Chemother 12:630 [PubMed]
8. Macrobid and Nitrofurantoin (Third Trimester)
a. Do not use either of these past 36 weeks
b. Can cause Hemolytic Anemia in newborns
c. Related to immature liver and G6PD Deficiency
C. Vaccines
1. Yellow Fever Vaccine

Class X: Very high risk to the human fetus

A. Antimalarial agents
1. Quinine
B. Antiviral agents
1. Ribavirin
2. Rebetron - not in Briggs (1998)
C. Vaccines
1. MeaslesVaccine
2. Mumps Vaccine
3. RubellaVaccine
4. Small PoxVaccine
5. TC-83 Venezuelan Equine EncephalitisVaccine
6. Varicella Vaccine
a. Risk if vaccinated within 4 weeks of conception
b. Theoretic risk only; not an indication for EAB

Upper Respiratory Medications in Pregnancy


Class B: No risk in controlled animal studies

A. Ammonium Chloride
B. Azatadine
C. Chlorpheniramine (Chlor-Trimeton)
1. Antihistamine of choice in pregnancy (but sedating, limit to night-time)
D. Clemastine (Tavist)
E. Cyproheptadine
F. Diphenhydramine (Benadryl)
1. Oxytocin-like effect at high dose
2. Crosses placenta
G. Doxylamine (Unisom)
H. Loratidine (Claritin)
1. Best to avoid in first trimester
I. Meclizine (Antivert)
J. Intranasal Budesonide (Rhinocort)
1. Safe in pregnancy (but use lowest effective dose)

Class C: Small risk in controlled animal studies

A. Guaifenesin (Robitussin)
1. Early use may be associated with Neural Tube Defects
2. Avoid combination products containing Alcohol
3. Avoid in first trimester
B. Dextromethorphan (Robitussin DM)
1. No increased risk in Collaborative Perinatal Project
C. Intranasal Beconase AQ (beclomethasone)
D. Benzonatate (Tessalon Perles)
E. Codeine
1. Avoid in first trimester
F. Hydrocodone
G. Diphenhydramine (Benadryl)
1. Avoid in first trimester
H. Pseudophedrine (Sudafed)
1. Associated with Gastroschisis, small intestinal atresia and hemifacial microsomia (avoid in
first trimester)
2. Avoid in first trimester
I. Brompheniramine
J. Hydroxyzine (Atarax)
K. Promethazine (Phenergan)
L. Oxymetazoline (Afrin)
1. Avoid in pregnancy (especially in first trimester)
2. Significant absorption from the nasal mucose
M. Cetirizine (Zyrtec)
1. Avoid in first trimester
N. Fexofenadine (Allegra)

Class D: Strong Evidence of Risk to the Human Fetus

A. Terpin Hydrate
B. Iodides

OTC IN PREGNANCY

Upper Respiratory Medications

A. First-generation Antihistamines (Sedating Antihistamines)


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

Analgesics and antipyretics

A. Acetaminophen
1. Crosses the placenta
2. FDA Category B (first-choice agent)
B. 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)
C. 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)

Gastrointestinal medications

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

A. Herbal agents that appear safe in pregnancy


1. Echinacea
2. Glucosamine
a. Used for Joint Pain
3. Ginger
a. Appears effective for Morning Sickness
b. Appears safe in pregnancy
i. Early reports of Spontaneous Abortion and Preterm Labor were not
found in larger trials
B. 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
C. Herbal agents that are considered unsafe in pregnancy (avoid)
1. St. John's Wort
a. Lack of safety data
2. Feverfew
a. Inhibits platelet aggregation
b. Inhibits prostglandin production
3. Ephedra
a. Anencephaly risk
b. Transposition of the Great Vessels risk
c. Aortic Stenosis risk

Topical Dermatologic Preparations

A. Topical Antifungal agents


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

CARDIOVASCULAR DRUGS IN PREGNANCY

Class B: No risk in controlled animal studies

A. Anticoagulants
1. Enoxaparin (Lovenox)
2. Dalteparin (Fragmin)
3. Danaparoid (Orgaran)
4. Heparin
B. Antihypertensives
1. Methyldopa (Aldomet)
2. Acebutolol (first trimester only)
3. Pindolol (first trimester only)
C. Antiarrhythmic
1. Encainide
2. Sotalol (Betapace) - first trimester only
D. Diuretics
1. Torsemide (Demadex) - not in Briggs (1998)
2. Amiloride
E. AntiHyperlipidemic
1. Cholestyramine
2. Colestipol

Class C: Small risk in controlled animal studies

A. Antiplatelet Medications
1. Clopidogrel (Plavix) - not in Briggs (1998)
2. Dipyridamole (Persantine)
3. Ticlopidine (Ticlid) - not in Briggs (1998)
B. Antiarrhythmic
1. Atropine
2. Digoxin
3. Disopyramide (Norpace)
4. Lidocaine
5. Procainamide
6. Quinidine
7. Amiodarone
a. Neonatal Hypothyroidism
b. Intrauterine Growth Retardation
c. Cardiac disturbance
C. Antihypertensive
1. Hydralazine
2. Diazoxide
3. Clonidine
4. Nitroprusside (Nipride)
5. Prazosin
6. Reserpine
7. All Calcium Channel Blockers
a. Nifedipine XL (is a drug of choice for severe Hypertension in Pregnancy)
b. Avoid other Calcium Channel Blockers in pregnancy
8. Most Beta Blockers (first trimester only)
a. Labetolol (drug of choice for severe Hypertension in Pregnancy)
b. Metoprolol
c. Nadolol
d. Propranolol
e. Timolol
f. Esmolol (Class C in all trimesters)
D. Diuretics
1. Acetazolamide (Diamox)
2. Furosemide (Lasix)
3. Mannitol
E. Lipid lowering medications
1. Niacin
2. Gemfibrozil (Lopid)

Class D: Strong evidence of risk to the human fetus

A. Anticoagulants
1. Coumadin (Warfarin)
2. Dicumarol
B. Antihypertensive
1. ACE Inhibitors
2. Angiotensin II Antagonists
3. Most Beta Blockers (second and third trimester)
a. Associated with Intrauterine Growth Retardation
b. Metoprolol
c. Nadolol
d. Propranolol
e. Timolol
f. Acebutolol (second and third trimester)
g. Pindolol (second and third trimester)
h. Atenolol
C. Diuretics
1. Ethacrynic Acid
2. Triamterene (Class B per manufacturer)
3. Bumetanide (Bumex)
4. Hydrochlorothiazide
5. Spironolactone

Class X: Very high risk to the human fetus

A. HMG CoA Reductase Inhibitors (Statins)


1. Fluvastatin
2. Lovastatin
3. Pravastatin
4. Simvastatin
Gastrointestinal Medications in Pregnancy
Class A: No risk in controlled human studies

A. Pyridoxine (Vitamin B6)

Class B: No risk in controlled animal studies

A. Milk of Magnesia
B. Doxylamine
C. Metoclopramide
D. Calcium Carbonate (Tums)
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
5. May interfere with iron absorption
E. Aluminum hydroxide (Maalox, Mylanta)
1. Pregnancy risk class is unknown, but appears safe in pregnancy
2. May interfere with iron absorption
3. Neurotoxicity and fetal malformation risk at high dose
F. Magnesium Hydroxide or Magnesium carbonate (Maalox, Mylanta)
1. Pregnancy risk class is unknown, but appears safe in pregnancy
2. May interfere with iron absorption
G. Kaolin-pectin (Kaopectate)
1. Previously considered antidiarrheal of choice in pregnancy but now contains bismuth
and Aspirin
2. Not absorbed but risk of Iron Deficiency Anemia
H. Sucralfate
I. Meclizine (Antivert)
J. Mesalamine
K. Ranitidine (Zantac)
1. Crosses placenta but considered safe
2. Used as second line after maalox, mylanta or tums
L. Cimetidine (Tagamet)
1. Crosses placenta but considered safe
2. Used as second line after maalox, mylanta or tums
3. Ranitidine may be preferred over Cimetidine for longer term use
M. Famotidine (Pepcid)
1. Limited human data
2. Crosses the placenta
N. Lactulose
O. Simethicone
1. Not absorbed and does not cross the placenta, so considered safe in pregnancy
P. Proton Pump Inhibitors
1. Cross 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, but appears safe in
pregnancy and is best studied of the PPI agents (see below)

Class C: Small risk in controlled animal studies


A. Hydroxyzine (Vistaril)
B. Prochlorperazine (Compazine)
C. Droperidol (Inapsine)
D. Metamucil
E. Bismuth Subsalicylate (Pepto Bismol)
1. Risk of Salicylate absorption
2. Not recommended in pregnancy (especially in second and third trimester due
to Aspirin component)
F. Loperamide (Imodium)
1. Possible associations with fetal cardiovascular defects
2. Avoid in first trimester
G. Atropine-Diphenoxylate (Lomotil)
1. Class D in third trimester
2. Not recommended in pregnancy
H. Nizatidine (Axid)
1. Avoid in pregnancy
2. IUGR, fetal death and abortion seen in rabbit studies
I. Docusate Sodium (Colace)
J. Promethazine (Phenergan)
K. Senna
L. Polyethylene glycol 3350 (Miralax)
1. Preferred Laxative for Constipation in Pregnancy
M. Omeprazole
1. FDA Category C for Omeprazole (Prilosec) based on animal studies
2. However appears safe in pregnancy and is best studied of the PPI agents
N. Mineral Oil
1. Not absorbed (and does not cross the placenta)
2. Avoid in pregnancy
3. Risk of fat soluble Vitamin Decreased absorption (risk of neonatal coagulopathy and
bleeding complications)

Class X: Very high risk to the human fetus

A. Misoprostol
B. Bismuth Subsalicylate (Pepto Bismol) in trimester 3
C. Castor oil

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