drugs and pregnancy adrea r. benkoff, m.d.. diagnostic ophthalmic drugs therapeutic ophthalmic drugs...
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DRUGS AND PREGNANCYAdrea R. Benkoff, M.D.
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Diagnostic Ophthalmic DrugsTherapeutic Ophthalmic Drugs
Relative Benefit to MotherSide Effects in Pregnant Patients
Potential Risk to FetusStructural or Visceral AbnormalitiesAltered Physiologic Function of Nursing Baby
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TERATOGEN
An Agent That By Acting During the
Embryonic or Fetal Period Produces
Morphologic or Functional Malformations
That Become Apparent Postnatal
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SOURCES
Case Reports
Individual Experience
Animal Studies
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SYSTEMIC EFFECTS
Oral Medications
Topical MedicationsAbsorbed Systemically by Drainage
Through Nasopharyngeal MucosaSecreted in Breast Milk
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FDA CATEGORIES FOR DRUG USE IN PREGNANCY
Category A--- Adequate and well controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Category B--- Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Category C--- Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category D--- There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category X--- Studies in animals or humans have demonstrated fetal abnormalities and /or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
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DIAGNOSTIC AGENTSTOPICAL ANESTHETICS
No Teratogenic Effects
MYDRIATIC/CYCLOPLEGIC AGENTSNo Animal Studies on DropsSystemic Use of Atropine, Epinephrine,
Homatropine or PhenylephrineMinor, Non-Life-Threatening Malformations
Systemic ScopalamineFetal Tachycardia and Heart Rate Variability
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DIAGNOSTIC AGENTSSystemic Phenylephrine
Fetal Hypoxia and Bradycardia
Unknown if Excreted in Breast MilkLow Weight Infants are Susceptible to Systemic
Hypertension with 2.5% or 10% Phenylephrine Drops
Avoid Use in Nursing Mothers
All Mydriatic/Cycloglegic Drops – Category CRelatively Contraindicated Due to Fetal Hypoxia in
Late Pregnancy and Delivery
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DIAGNOSTIC AGENTSFLUORESCEIN DYE
Crosses PlacentaEnters Fetus in Humans and Animals
No Adverse Effects Reported in HumansCategory C Rating
Avoid Angiography on Pregnant Patients Especially Those in the First Trimester
Detected in Breast MilkStop Breastfeeding for Hours or Days if Used
Topically or by IV
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DIAGNOSTIC AGENTS
INDOCYANINE GREEN DYEUsed Non-Ophthalmically in Pregnant Women for
Measuring Hepatic Blood FlowNo Adverse Effects on Mother or Fetus
Does Not Cross PlacentaNot Known if Present in Breast MilkPregnancy Category C Rating
Use Only if Clearly Indicated
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GLAUCOMA MEDICATIONS
INCIDENCE OF GLAUCOMALow in Women of Child-Bearing Age
DISEASE SEVERITYYoung Mothers May Tolerate Small Increases in
IOP During PregnancyDecrease or Hold Treatment to Limit Risk to Fetus
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Beta-Adrenergic Antagonists
Topical Medications Include: Betagan, Betimol, Istalol, Ocupress, and Timoptic
Systemic Side Effects in GeneralRespiratory Distress, Bradycardia, Heart Failure,
Fatigue, DepressionTopical Medications Bypass Hepatic Metabolism
and Are Not Inactivated (unlike oral beta-blockers)Despite Low Dosage In Children: Bradycardia & Apnea
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Beta-Adrenergic Antagonists
Systemic Therapy Effects in PregnancyApnea Intrauterine Growth RetardationNeonatal Depression at Birth (Low APGAR)Postnatal HypoglycemiaBradycardia
Effects of Topical Use in PregnancyCase Reports of Timolol Show Both No Effects and
Adverse EffectsCase Report: Decrease Concentration From 0.5%
to 0.25% Decreased Fetal Arrythmia
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Beta-Adrenergic Antagonists
Beta-Blockers and Breast FeedingSecreted and Concentrated in Breast MilkCase Report: Apnea in 18 mo/old Child Being
Breast Fed
Rating- Pregnancy Category CPotential for Serious Adverse Side EffectsDiscontinue Nursing or Discontinue Drug, Taking
Into Account the Importance of the Drug to the Mother
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Carbonic Anhydrase Inhibitors
Oral Agents (Acetazolamide/Diamox)Animal Studies: Malformations, Electrolyte
ImbalanceNational Collaborative Perinatal Project
No Incidence in Major or Minor Fetal Abnormalities in Infants Where Mothers Took Medication at Different Stages of Pregnancy
Study Size Considered Too SmallHepatic and Renal Effects on Infants Being Breast
Fed
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Carbonic Anhydrase Inhibitors
Topical Agents (Dorzolamide/Trusopt and Brinzolamide/Azopt)Published Reports LimitedNo Adverse Effects ReportedNot Known if Excreted in Breast Milk
Rating – Pregnancy Category CDiscontinue Nursing or Discontinue Drug, Taking
into Account the Importance of the Drug to the Mother
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Sympathomimetics
Epinephrine (Epifrin)Stimulates Both Alpha and Beta Adrenergic
ReceptorsHuman Studies: Systemic Use in First Trimester
Associated with Minor and Major Anomalies-- Inguinal Hernias
Rating-- Pregnancy Category C
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Sympathomimetics Dipivefrin Hydrochloride (Propine)
Prodrug of Epinephrine Converted by Corneal Enzymes Animal Studies: Negative for Side Effects Not Known if Excreted in Breast Milk Rating-- Pregnancy Category B
Brimonidine (Alphagan P)—Apraclonidine Hydrochloride (Iopidine) Selective Alpha-2 Adrenergic Agonists Case Reports: No Adverse Side Effects During Pregnancy Not Known if Excreted in Breast Milk
Alphagan P Caused CNS Depression, Somnolence, Apnea in Neonates and Infants
Rating– Alphagan P– Pregnancy Category B Iopidine– Pregnancy Category C
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Prostaglandin Analogues
Latanaprost (Xalatan), Bimatoprost (Lumigan), Travoprost (Travatan)
Prostaglandins Action in LaborCauses Uterine Contractions of Uterine Smooth
Muscles
Animal Studies of Systemic Prostaglandins Increase Risk of Abortion or Preterm Delivery
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Prostaglandin AnaloguesHuman Studies of Topical Prostaglandins
Case Studies: No Adverse Effect on Pregnancy or Neonatal Outcome
Excretion in Breast Milk Positive in Animal Studies Unknown in Humans
Rating—Pregnancy Category C Because of Potential Effects on Uterine Muscle
Contractibility Prostaglandin Should Be Avoided in Women Who Are
Pregnant or Desire to Become Pregnant
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MioticsParasympathomimetic Agents
Includes Direct Acting Cholinergic Agents: Pilocarpine & Carbachol
Animal Studies:Pilocarpine--Limb AbnormalitiesCarbachol– Cervical Vertebrae Abnormalities
Human Study: Systemic PilocarpineNo Side Effects in First 4 Months of GestationNear Term: Neonatal Hyperthermia, Seizures,
RestlessnessRating—Pregnancy Category C
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CORTICOSTEROIDSSystemic Corticosteroids
Increase Risk of Stillbirth Intrauterine Growth Retardation and Adrenal
Insufficiency
Topical CorticosteroidsAnimal Studies:
Developmental and Teratogenic Effects Including Cleft Lip, Cleft Palate & Sex Organ Abnormalities in Mice
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CORTICOSTEROIDS
Excreted in Breast MilkPresent if Administered Systemically
Suppressed Growth or Interferes with Endogenous Production
Unknown if Present as a Topical Medication
Rating—Pregnancy Category CAvoid Use During Nursing Given Potential Serious
Adverse Reactions.
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ANTIBIOTICS
Erythromycin & Polymyxin BNo Known Congenital Defects
AminoglycosidesGentamycin, Streptomycin, Tobramycin, NeomycinCase Studies in Humans: Used IV with No
Teratogenic AbnormalitiesAnimal Studies: Hearing Loss, Nephrotoxicity
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ANTIBIOTICSSulfonamides
Animal Studies: Increase Cleft Palate and Other Bony Abnormalities
Human Case Reports: Hyperbilirubinemia in Infant if Used During Third Trimester of Pregnancy
FluoroquinolonesAnimal Studies of Topical Ciloxan, Ocuflox, Quixin,
Vigamox & Zymar:No Teratogenic Effects
Animal Studies with High DosesDecrease Body Weights, Delayed Skeletal Development
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ANTIBIOTICSTetracycline
Human Case Reports– Systemic Use: Permanent Discoloration of Teeth in Offspring
Excreted in Breast MilkPositive with Systemic Erythromycin, Tetracycline &
CiprofloxacinMaternal Medications Usually Compatible with Breast
Feeding By American Academy of Pediatrics
Rating:Pregnancy Category B--ErythromycinPregnancy Category C--Gentamycin, Neomycin, Polymyxin
B, Sulfonamides, FluoroquinolonesPregnancy Category D-- Tetracycline
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ANTIVIRALSTopical: Trifluridine (Viroptic) & Vidarabine
( Vira-A)For Treatment of HSV KeratitisRating– Pregnancy Category C
Avoid in Pregnancy Due to Teratogenic and Tumorgenicity Effect
Oral: Acyclovir (Zovirax) & Valacyclovir (Valtrex)For Treatment of Epithelial Corneal DiseaseRating--Pregnancy Category B
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THERAPY FOR CHOROIDAL NEOVASCULARIZATION
Verteporfin (Visudyne)Human Studies: NoneAnimal Studies: Increase Anophthalmia and
Microphthalmia in Rat FetusesRating– Pregnancy Category C
Pegaptanib (Macugen)Human Studies: NoneAnimal Studies: No Maternal or Fetal AbnormalitiesRating– Pregnancy Category B
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THERAPY FOR CHOROIDAL NEOVASCULARIZATION
Bevacizumab (Avastin)Human Studies: NoneAnimal Studies: Teratogenic in Rabbits, Disrupts
AngiogenesisRating – Pregnancy Category C
Ranibizumab (Lucentis)Human Studies: NoneAnimal Studies : NoneRating-- Pregnancy Category C
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ANTI-INFLAMMATORY DRUGS
Cyclosporine (Restasis) ImmunomodulatorAnimal Studies: No AbnormalitiesBreast Milk: Excreted When Used SystemicallyRating—Pregnancy Category C
NSAIDSFlurbiprofen (Ocufen)
Animal Studies: Embryocidal, Prolonged Gestation, Retarded Growth
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ANTI-INFLAMMATORY DRUGS
Diclofenac (Voltaren)Animal Studies: Crosses Placenta
Nepafenac (Nevanac)Animal Studies: Crosses PlacentaFound in Breast Milk
Bromfenac (Xibrom)
Ketorolac (Acular)
All NSAIDS Rating- Pregnancy Category CAffects Fetal Cardiovascular System
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MEDICAL MARIJUANA
Crosses PlacentaContains Toxins-- Decrease Oxygen to Fetus Increases Miscarriage, Low Birth Weight,
Premature Birth, Developmental Delays, Behavioral and Learning Problems, Increase Childhood Leukemia
Excreted in Breast MilkActive Ingredient THC-- Impairs Infant Motor
Development
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COMMUNICATION
Clear Indication for Use
Relative Benefits vs. Potential RisksBirth Defects Occur in 2% or More of All Neonates.
Drugs Used Coincidently Might Be Wrongly Implicated as Contributing to a Birth Defect
Discussion with Patient and Obstetrician
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DOSAGE
Minimal Effective Dose
Shortest Duration
Limit Systemic Absorption of DropsNasolacrimal Duct OcclusionEyelid ClosureRemoval of Excess Medication with Absorbent
Material
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OPHTHALMIC OINTMENTS
Safety Profile Different from Drops
Ointment Creates Reservoir of Active Drug
Prolonged Absorption Time
Reduced Serum Level of Medication
May Create Lower Therapeutic Level Within Eye
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DIAGNOSTIC AGENTSRoutine Use of Anesthetic Drops or Dilating Drops
Should be AvoidedUNLESS:
New Symptoms OccurMonitoring of Specific Disease (i.e. Diabetic Retinopathy)
Lowest Concentration and DurationTropicamide 0.5%
Fluorescein Dye and ICG DyeVitreoretinal Specialists Avoid Use During PregnancyUse OCT instead
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THERAPEUTIC AGENTS
CorticosteroidsUse Topically with Caution
AntibioticsErythromycin—Relatively SafeTetracycline—AvoidFluoroqinolones—Effects Unknown
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THERAPEUTIC AGENTSAntivirals
Topical Viroptic & Vira-A – Avoid Because of Tumor Formation and Teratogenic Effect
Oral Zovirax & Valtrex – Relatively Safe For Treatment of Epithelial Keratitis
Anti-Inflammatory DrugsRestasis – Use Only if Clearly NeededNSAIDS – Avoid Use in Late Pregnancy Because of
Fetal Cardiovascular System Complications
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THERAPEUTIC AGENTSGlaucoma Treatment
ProstaglandinsAvoid Due to Effects on Uterine Contractility
Topical Beta BlockersReported Positive and Negative for Fetal Side Effects
Topical Carbonic Anhydrase InhibitorsRelatively Safe After First Trimester
Propine & AlphaganBoth are Pregnancy Category BAvoid Use of Alphagan at Term of Pregnancy Due to
Reports of Apnea and Somnolence in Neonates
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NURSING MOTHERDilating Drops – Avoid Due to Infant Systemic
Hypertension
Fluorescein Dye – If Use Necessary, Must Stop Breastfeeding for Hours or Days
Corticosteroids – Potentially Serious Side Effects
Antibiotics – American Academy of Pediatrics Classified Erythromycin, Gentamycin, Tetracycline & Ciprofloxacin as “Maternal Medications Usually Compatible with Breast Feeding”
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NURSING MOTHERAntivirals
Topicals – Avoid Unless Benefit Outweighs RiskOrals – Found in Breast Milk, Use with Caution
Anti-Inflammatory DrugsRestasis & NSAIDS – Use with Caution
Glaucoma TreatmentPropine & Alphagan P – Not Known if Excreted in
Breast MilkBeta Blockers, CA Inhibitors, Pilocarpine, Carbachol,
Epifrin, Iopidine, Prostaglandins – Discontinue Nursing or Discontinue Drug
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GUIDELINES
FOR
MANAGEMENT
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HSV KERATITIS DURING PREGNANCY
Epithelial LesionsFrequently Dendritic and Often Contain Live VirusDendrites May Heal Spontaneously After
Debridement and LubricationTopical Viroptic Used in Appropriate Dosage
Unlikely to Cause Fetal Damage
Stromal KeratitisHerpetic Eye Disease Study– Topical Antiviral
Therapy with Topical Steroids Reduces Progression and Duration of Disease
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HSV KERATITIS DURING PREGNANCY
IridocyclitisAddition of Oral Zovirax to Topical Antiviral
Therapy and Corticosteroid was BeneficialNo Fetal Abnormalities from Oral Zovirax or
Valtrex Reported
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OPTIC NEURITIS IN FIRST TRIMESTER DUE TO DEMYLENATING DISEASE
Optic Neuritis Treatment Trial IV Methylprednisolone
Faster Resolution of the Visual Loss but Did NOT Affect Long-Term Outcome After 6 Months
Decrease Risk of Recurrence of Optic Neuritis and Development of MS in the Future
No IV SteroidsOnly Observation in the First Trimester as the Risk
of Fetal Abnormalities Outweighs the Benefit of Faster Visual Recovery
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CHRONIC UVEITISMainstay of Treatment
Topical CycloplegiaNo Teratogenic Effects
Topical CorticosteroidsNo Teratogenic Effects
If Oral Steroids and/or Nonsteroidals (Methotrexate) Are NeededNO Methotrexate-- Known TeratogenNO Systemic Steroids– Risk of Cleft Lip and Palate
Consider Periocular or Intravitreal SteroidsSecondary to Reduced Systemic LevelsWeigh Risk/Benefits to Patient
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GLAUCOMA DURING PREGNANCY AND LACTATION
Several Glaucoma Medications Have Potential Adverse Effects in the Fetus or Breastfeeding Infant Beta-Blockers—Class C Alpha 2 Agonists (Alphagan P)– Class B Prostaglandin Analogues– Class C Topical and Oral Carbonic Anhydrase Inhibitors– Class C
Alternatives Include: Laser Trabeculoplasty Observation OFF Treatment
Avoid Glaucoma Surgery Because of Anesthetic Concerns, Surgical Positioning and
Intra and Peri-Operative Medications
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WORSENING OF GLAUCOMA IN DRUGS USED TO TREAT ECLAMPSIA AND
PREMATURE LABORManagement of Premature Labor and Eclampsia
Beta-MimeticsRarely Causes Acute Angle-Closure Glaucoma
Magnesium SulfatePtosis, Accommodative and Convergence Insufficiency with
Diplopia and/or Pupillary AbnormalitiesAntiprostaglandins (Indocin)
Decreases IOP Lowering Effect of Epinephrine in Glaucoma Patients
After Treatment for Premature Labor, Pregnant Woman is Given Glucocorticoids for 2 Days Before DeliveryGlaucoma May Worsen After Steroid Therapy