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Some ophthalmic drugs not safe for use in lactating or pregnant women
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The U.S. Food and Drug Administration assigns all drugs into one of five safety categories according to its “use-in-pregnancy rating system.” This system analyzes available human and animal clinical data and determines the degree of risk for teratogenic effects on the fetus.
Category A medications have proven safety (possibility of fetal harm appears remote); Category B drugs have presumed safety; Category C drugs have uncertain safety; and Category D medications are unsafe, although their benefits may be acceptable in certain situations despite the risk. Category X drugs are unsafe and contraindicated in women who are or may become pregnant; that is, the risk of using these medications outweighs any potential benefits.
Little human data exists with regard to topical ophthalmic medications. However, concerns arise because pharmaceuticals may be absorbed systemically through the lacrimal mucosa. Therefore, subsequent drug passage through the placental barrier (initial organ system differentiation occurs during the first trimester), effects on labor and delivery and breast milk excretion must be considered. Category C drugs and lower (D and X) are not recommended during pregnancy.
Topical ophthalmic dyes and anesthetics are generally considered safe in both pregnant and breastfeeding women. Mydriatic agents, however, should be used only when necessary during pregnancy and not at all during lactation. Dilation should not be routinely performed, but rather used only when individuals have a pre-existing condition such as diabetic retinopathy or signs and symptoms warrant such examination. Cycloplegics should not be used diagnostically and should be used with caution when necessary for therapeutic purposes. Mydriatic reversal agents are not essential and should not be administered.
Brimonidine carries a Category B rating and appears as one of the safer glaucoma medications to use during pregnancy. It should not be used during lactation, however, as its use has been associated with infant and neonatal central nervous system depression. Erythromycin ophthalmic ointment is the only antibiotic classified as Category B.
After any eye drop is instilled, whether in the office or at home, lacrimal sac compression and eye drop closure techniques should be used. Patients should be instructed to close their eyes while the lacrimal sac is compressed for 2 to 3 minutes. Removal of excess medication and tears with an absorbent tissue also limits systemic absorption and should be performed.
Many oral antibiotics are Category B and relatively safe, with exceptions.
When therapeutic intervention is necessary, the practitioner should ensure that the medication poses minimal risk to the mother/fetus and provides maximum therapeutic benefit at the lowest possible dose. It is also recommended that the eye care practitioner always contact the patient’s obstetrician/physician when either topical or oral therapy is contemplated.
| Dr. Trad’s guide to using ophthalmic agents during pregnancy and lactation | ||
| Category | FDA rating | Use during lactation, other comments |
| TOPICAL AGENTS | ||
| Anesthetics | C | Use with caution |
| Dyes/stains | C | Use with caution |
| Mydriatic reversal agent: dapiprazole | B | Unnecessary to use |
| Mydriatics/cycloplegics: tropicamide, cyclopentolate, atropine, hydroxyamphetamine/tropicamide | C | Use with caution/routine dilation not advised |
| Hyperosmolar agents | C | Use with caution |
| Antibiotics: gatifloxacin, moxifloxacin, levofloxacin, ofloxacin, norfloxacin, ciprofloxacin, gentamicin, sulfacetamide, trimethoprim/ polymyxin B, bacitracin, neomycin | C | Discontinue drug or nursing |
| Antibiotics: erythromycin | B | Use with caution/Good safety profile in pregnancy |
| Antibiotics: tobramycin | D | Discontinue drug or nursing/Do not use in pregnant women |
| Allergy mediciations: antazoline, naphazoline, pheniramine, oxymetazoline, tetrahyrdozoline, zinc sulfate, olopatadine, pemirolast, ketotifen, epinastine, azelastine | C | Use with caution |
| Allergy medications: emedastine, lodoxamide, nedocromil, cromolyn | B | Use with caution |
| Anifungals: natamycin | C | Use with caution/Infant risk cannot be ruled out |
| NSAIDs: Ketorolac tromethamine, diclofenac, Nevanac (nepafenac 0.1%, Alcon), Xibrom (bromfenac 0.09%, Ista) | C | Use with caution/Avoid during late pregnancy (third trimester) due to potential effects on fetal cardiovascular system |
| Antivirals: trifluridine | C | Discontinue drug or nursing |
| Antivirals (off-label): povidone-iodine | C | Use with caution/Potential off-label use for acute adenoviral infection |
| Dry eye: cyclosporine | C | Use with caution |
| Steroids: rimexolone, loteprednol, prednisolone, fluorometholone, dexamethasone | C | Use with caution/Best to discontinue drug or nursing |
| Glaucoma: brimonidine | B | Discontinue drug or nursing |
| Glaucoma (beta-blockers): timolol, betaxolol, levobunolol | C | Use with caution/It is best to avoid beta-blockers during the first trimester. If necessary during the last two trimesters, use a 0.25% concentration. Beta-blockers should be discontinued at least 48 to 72 hours prior to delivery. Infants of nursing mothers must be observed for signs of beta blockade (apnea, bradycardia). |
| Glaucoma: latanoprost, travopost, bimatoprost | C | Use with caution |
| Glaucoma: pilocarpine | C | Use with caution |
| Glaucoma: dorzolamide, brinzolamide | C | Use with caution |
| ORAL AGENTS | ||
| Antibiotics: erythromycin, azithromycin, cefadroxil, amoxicillin, amoxicillin/clavulanate, cephalexin, cefaclor | B | Use with caution/Infant risk cannot be ruled out |
| Antibiotics: levofloxacin, clarithromycin | C | Use with caution/Infant risk cannot be ruled out |
| Antibiotics: sulfamethoxazole/trimethoprim | C | Not recommended for use as potentially nephrotoxic |
| Antibiotics: tetracycline | Unknown | Contraindicated in pregnant and nursing mothers due to abnormal bone development in the fetus and infant |
| Antibiotics: doxycycline | D | See “tetracycline” |
| Analgesics: acetaminophen | Unknown | Risk cannot be ruled out, although found to be largely compatible with lactation |
| Analgesics: ibuprofen, aspirin | D | Avoid use in nursing mothers/Infant risk cannot be ruled out |
| Antivirals: acyclovir, famciclovir, valacyclovir | B | Infant risk appears minimal |
| Steroids: prednisone, methylprednisolone | Unknown | Use with caution/Infant risk cannot be ruled out |
| Carbonic anhydrase inhibitors: acetazolamide | C | Use with caution/Infant risk cannot be ruled out |
| Author’s disclosure: The author has attempted, to the best of his knowledge, to present the most accurate available information. However, the author assumes neither responsibility nor liability for incorrect information, changes in drug categorization or practitioner’s prescribing habits. It is the responsibility of each prescriber to personally and independently verify any and all information. Source: MJ Trad | ||
For more information:
Michael J. Trad, OD, practices at the Marshfield Clinic in Marshfield, Wis., and may be contacted at trad.mike@hotmail.com.