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I. Pregnancy category
In 1979, the FDA introduced the pregnancy category classification of fetal risks. Unfortunately, it does not indicate
any risks associated with lactation.
Pregnancy Category A: Clinical implication: no risk to the fetus.
Pregnancy Category B: Clinical implication: no evidence of risk.
Pregnancy Category C: Clinical implication: Risk to the fetus cannot be ruled out.
Pregnancy Category D: Clinical implication: Risk to the fetus, but benefits may outweigh risk.
Pregnancy Category X: Clinical implication: Definite risk, avoid.
II. Fetal risk
A. From conception to two weeks, there is an “all or none” effect. The zygote dies from exposure or remains
unaffected.
B. Weeks 4 through 10 is the most likely time for congenital malformations to occur.
C. During the second and third trimester, drugs are may influence processes such as neurologic or mental development.
III. Tips and hints
A. 6.4 million pregnant women in 2000
B. Nasolacrimal occlusion minimizes systemic drug absorption. Some experts always recommend nasolacrimal
occlusion for all pregnant patients.
C. Eyelid closure after installation increases ocular efficacy and decreases systemic absorption.
D. Use minimally effective doses
E. Shorter duration of treatment
Remember: Highest risk of fetal dysmorphosis is around first four to ten weeks Whenever possible, nonpharmacologic
intervention may be more prudent.
IV. The drugs
A. Antimicrobials
Zymar (Pregnancy Category C): Excreted in the breast milk of rats. Unknown if excreted in human milk.
Vigamox (Pregnancy Category C): Excreted in the breast milk of rats. May be excreted in human milk.
Erythromycin (Pregnancy Category B): Excreted in breast milk with delayed release capsules. Unknown if excreted in
human milk with topical.
Tobramycin (Pregnancy Category B): Potential for adverse reactions in nursing infants.
Note: Erythromycin and Tobramycin are both Pregnancy Category B. They can be considered useful antibiotic
alternatives when appropriate.
Doxycycline (Pregnancy Category D): Excreted in human milk.
Tetracycline (Pregnancy Category D): Excreted in human milk.
Note: Although doxycycline and tetracycline are not a topical medications, they are commonly prescribed for lid
disease and meibomian gland dysfunction. Unfortuntately, both are Pregnancy Category D.
Neomycin (Pregnancy Category D): Unknown if excreted in human milk but excreted in cow milk. Other
aminoglycosides have been shown to be excreted in human milk.
B. Dry eyes
Restasis (Pregnancy Category C): Excreted in human milk after systemic administration but excretion in human milk
after topical not investigated. Blood concentrations are undetectable with Restasis.
C. Corticosteroids: Alrex and Lotemax (Pregnancy Category C): Unknown if excreted in human milk. Systemic
steroids appear in human milk.
D. Combination antibiotic and steroid
Zylet (Pregnancy Category C): Unknown if excreted in human milk. Systemic steroids appear in human milk.
Tobradex (Pregnancy Category C): Systemic steroids appear in human milk. Unknown if topical produces detectable
quantities in human milk.
E. Allergy medications
Patanol (Pregnancy Category C): Identified in the milk of nursing rats with oral. Unknown if topical produces
detectable quantities in the human breast milk.
Elestat (Pregnancy Category C): Lactating rats revealed excretion in the breast milk.
Zaditor (Pregnancy Category C): Identified in breast milk in rats with oral.
Alocril (Pregnancy Category B): Unknown if excreted in human milk.
Emadine (Pregnancy Category B): Identified in breast milk in rats with oral.
Alomide (Pregnancy Category B): Unknown if excreted in human milk.
F. Diagnostics
Cyclopentolate (Pregnancy Category C): Use with caution in infants; increased susceptibility
Tropicamide (no Category listed): better choice than cyclopentolate.
Proparacaine (Pregnancy Category C): fetal harm and excretion not known.
Note: diagnostics are usually not for long term use; low risk.
G. Glaucoma
One of our greatest clinical challenges may be prescribing for pregnant patients.
Humorsol (Demecarium Bromide) for glaucoma (Pregnancy Category X): Contraindicated for pregnant women.
Potential hazard to the fetus.
Beta blockers (Pregnancy Category C): Excretion into human milk detected.
Latanaprost (Pregnancy Category C): 25% had no viable fetuses in rabbits with oral doses; excretion in human milk
unknown.
Brimonidine (Pregnancy Category B): excreted into milk animal studies.
Notes: Use clinical judgement. Stop meds in first trimester when fetal risk is highest. Use punctal occlusion. Consider
Alphagan P. Laser trabeculoplasty can be performed during first trimester. Trabeculectomy safest in second trimester.
Most glaucoma meds are excreted, nursing not recommended.