DRUGS AND PREGNANCY Adrea R. Benkoff, M.D.. Diagnostic Ophthalmic Drugs Therapeutic Ophthalmic Drugs...

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Transcript of DRUGS AND PREGNANCY Adrea R. Benkoff, M.D.. Diagnostic Ophthalmic Drugs Therapeutic Ophthalmic Drugs...

  • DRUGS AND PREGNANCYAdrea R. Benkoff, M.D.

  • Diagnostic Ophthalmic DrugsTherapeutic Ophthalmic Drugs

    Relative Benefit to MotherSide Effects in Pregnant PatientsPotential Risk to FetusStructural or Visceral AbnormalitiesAltered Physiologic Function of Nursing Baby


    An Agent That By Acting During the Embryonic or Fetal Period Produces Morphologic or Functional Malformations That Become Apparent Postnatal


    Case Reports

    Individual Experience

    Animal Studies


    Oral Medications

    Topical MedicationsAbsorbed Systemically by Drainage Through Nasopharyngeal MucosaSecreted in Breast Milk

  • FDA CATEGORIES FOR DRUG USE IN PREGNANCYCategory 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.


    MYDRIATIC/CYCLOPLEGIC AGENTSNo Animal Studies on DropsSystemic Use of Atropine, Epinephrine, Homatropine or PhenylephrineMinor, Non-Life-Threatening MalformationsSystemic ScopalamineFetal Tachycardia and Heart Rate Variability

  • DIAGNOSTIC AGENTSSystemic PhenylephrineFetal Hypoxia and BradycardiaUnknown if Excreted in Breast MilkLow Weight Infants are Susceptible to Systemic Hypertension with 2.5% or 10% Phenylephrine DropsAvoid Use in Nursing MothersAll Mydriatic/Cycloglegic Drops Category CRelatively Contraindicated Due to Fetal Hypoxia in Late Pregnancy and Delivery

  • DIAGNOSTIC AGENTSFLUORESCEIN DYECrosses PlacentaEnters Fetus in Humans and AnimalsNo Adverse Effects Reported in HumansCategory C RatingAvoid Angiography on Pregnant Patients Especially Those in the First TrimesterDetected in Breast MilkStop Breastfeeding for Hours or Days if Used Topically or by IV


    INDOCYANINE GREEN DYEUsed Non-Ophthalmically in Pregnant Women for Measuring Hepatic Blood FlowNo Adverse Effects on Mother or FetusDoes Not Cross PlacentaNot Known if Present in Breast MilkPregnancy Category C RatingUse Only if Clearly Indicated


    INCIDENCE OF GLAUCOMALow in Women of Child-Bearing AgeDISEASE SEVERITYYoung Mothers May Tolerate Small Increases in IOP During PregnancyDecrease or Hold Treatment to Limit Risk to Fetus

  • Beta-Adrenergic AntagonistsTopical Medications Include: Betagan, Betimol, Istalol, Ocupress, and TimopticSystemic Side Effects in GeneralRespiratory Distress, Bradycardia, Heart Failure, Fatigue, DepressionTopical Medications Bypass Hepatic Metabolism and Are Not Inactivated (unlike oral beta-blockers)Despite Low DosageIn Children: Bradycardia & Apnea

  • Beta-Adrenergic AntagonistsSystemic Therapy Effects in PregnancyApneaIntrauterine Growth RetardationNeonatal Depression at Birth (Low APGAR)Postnatal HypoglycemiaBradycardiaEffects 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

  • Beta-Adrenergic AntagonistsBeta-Blockers and Breast FeedingSecreted and Concentrated in Breast MilkCase Report: Apnea in 18 mo/old Child Being Breast FedRating- Pregnancy Category CPotential for Serious Adverse Side EffectsDiscontinue Nursing or Discontinue Drug, Taking Into Account the Importance of the Drug to the Mother

  • Carbonic Anhydrase InhibitorsOral Agents (Acetazolamide/Diamox)Animal Studies: Malformations, Electrolyte ImbalanceNational Collaborative Perinatal ProjectNo Incidence in Major or Minor Fetal Abnormalities in Infants Where Mothers Took Medication at Different Stages of PregnancyStudy Size Considered Too SmallHepatic and Renal Effects on Infants Being Breast Fed

  • Carbonic Anhydrase InhibitorsTopical Agents (Dorzolamide/Trusopt and Brinzolamide/Azopt)Published Reports LimitedNo Adverse Effects ReportedNot Known if Excreted in Breast MilkRating Pregnancy Category CDiscontinue Nursing or Discontinue Drug, Taking into Account the Importance of the Drug to the Mother

  • Sympathomimetics

    Epinephrine (Epifrin)Stimulates Both Alpha and Beta Adrenergic ReceptorsHuman Studies: Systemic Use in First Trimester Associated with Minor and Major Anomalies-- Inguinal HerniasRating-- Pregnancy Category C

  • SympathomimeticsDipivefrin Hydrochloride (Propine)Prodrug of Epinephrine Converted by Corneal Enzymes Animal Studies: Negative for Side EffectsNot Known if Excreted in Breast MilkRating-- Pregnancy Category BBrimonidine (Alphagan P)Apraclonidine Hydrochloride (Iopidine)Selective Alpha-2 Adrenergic AgonistsCase Reports: No Adverse Side Effects During PregnancyNot Known if Excreted in Breast MilkAlphagan P Caused CNS Depression, Somnolence, Apnea in Neonates and InfantsRating Alphagan P Pregnancy Category BIopidine Pregnancy Category C

  • Prostaglandin Analogues

    Latanaprost (Xalatan), Bimatoprost (Lumigan), Travoprost (Travatan)Prostaglandins Action in LaborCauses Uterine Contractions of Uterine Smooth MusclesAnimal Studies of Systemic ProstaglandinsIncrease Risk of Abortion or Preterm Delivery

  • Prostaglandin AnaloguesHuman Studies of Topical ProstaglandinsCase Studies: No Adverse Effect on Pregnancy or Neonatal OutcomeExcretion in Breast MilkPositive in Animal StudiesUnknown in HumansRatingPregnancy Category CBecause of Potential Effects on Uterine Muscle ContractibilityProstaglandin Should Be Avoided in Women Who Are Pregnant or Desire to Become Pregnant

  • MioticsParasympathomimetic AgentsIncludes Direct Acting Cholinergic Agents: Pilocarpine & CarbacholAnimal Studies:Pilocarpine--Limb AbnormalitiesCarbachol Cervical Vertebrae AbnormalitiesHuman Study: Systemic PilocarpineNo Side Effects in First 4 Months of GestationNear Term: Neonatal Hyperthermia, Seizures, RestlessnessRatingPregnancy Category C

  • CORTICOSTEROIDSSystemic CorticosteroidsIncrease Risk of StillbirthIntrauterine Growth Retardation and Adrenal Insufficiency

    Topical CorticosteroidsAnimal Studies:Developmental and Teratogenic Effects Including Cleft Lip, Cleft Palate & Sex Organ Abnormalities in Mice


    Excreted in Breast MilkPresent if Administered SystemicallySuppressed Growth or Interferes with Endogenous ProductionUnknown if Present as a Topical MedicationRatingPregnancy Category CAvoid Use During Nursing Given Potential Serious Adverse Reactions.


    Erythromycin & Polymyxin BNo Known Congenital DefectsAminoglycosidesGentamycin, Streptomycin, Tobramycin, NeomycinCase Studies in Humans: Used IV with No Teratogenic AbnormalitiesAnimal Studies: Hearing Loss, Nephrotoxicity

  • ANTIBIOTICSSulfonamidesAnimal Studies: Increase Cleft Palate and Other Bony AbnormalitiesHuman Case Reports: Hyperbilirubinemia in Infant if Used During Third Trimester of PregnancyFluoroquinolonesAnimal Studies of Topical Ciloxan, Ocuflox, Quixin, Vigamox & Zymar:No Teratogenic EffectsAnimal Studies with High DosesDecrease Body Weights, Delayed Skeletal Development

  • ANTIBIOTICSTetracyclineHuman Case Reports Systemic Use: Permanent Discoloration of Teeth in OffspringExcreted in Breast MilkPositive with Systemic Erythromycin, Tetracycline & CiprofloxacinMaternal Medications Usually Compatible with Breast Feeding By American Academy of PediatricsRating:Pregnancy Category B--ErythromycinPregnancy Category C--Gentamycin, Neomycin, Polymyxin B, Sulfonamides, FluoroquinolonesPregnancy Category D-- Tetracycline

  • ANTIVIRALSTopical: Trifluridine (Viroptic) & Vidarabine ( Vira-A)For Treatment of HSV KeratitisRating Pregnancy Category CAvoid in Pregnancy Due to Teratogenic and Tumorgenicity EffectOral: Acyclovir (Zovirax) & Valacyclovir (Valtrex)For Treatment of Epithelial Corneal DiseaseRating--Pregnancy Category B


    Verteporfin (Visudyne)Human Studies: NoneAnimal Studies: Increase Anophthalmia and Microphthalmia in Rat FetusesRating Pregnancy Category CPegaptanib (Macugen)Human Studies: NoneAnimal Studies: No Maternal or Fetal AbnormalitiesRating Pregnancy Category B

  • THERAPY FOR CHOROIDAL NEOVASCULARIZATIONBevacizumab (Avastin)Human Studies: NoneAnimal Studies: Teratogenic in Rabbits, Disrupts AngiogenesisRating Pregnancy Category CRanibizumab (Lucentis)Human Studies: NoneAnimal Studies : NoneRating-- Pregnancy Category C

  • ANTI-INFLAMMATORY DRUGSCyclosporine (Restasis)ImmunomodulatorAnimal Studies: No AbnormalitiesBreast Milk: Excreted When Used SystemicallyRatingPregnancy Category CNSAIDSFlurbiprofen (Ocufen)Animal Studies: Embryocidal, Prolonged Gestation, Retarded Growth