PRESCRIBING IN PREGNANCY

Dr Vasudha Belgaumkar

Associate ProfessorDept. of DermatologyBJGMC Pune

Common Concerns ? •Contraceptive failure d/t drug

interactions

•Possible interference with conception

•Potential risk of spontaneous abortion

•Potential risk to mother/fetus

FDA Pregnancy Drug Risk Categories

X Contraindicated in pregnancyD Positive evidence for risk to fetusC Risk cannot be r/o.Human studies lackingB No risk to human fetusA Controlled studies – no fetal riskN No category assigned

Sources for InformationWHOTERISUSP-DIReproductive toxicology serviceAAP (lactation)Briggs GG et al

Before Conception

Contraceptive failure

Interference with conception

Contraceptive Failure

Azathioprine-------------- IUDNSAID---------------------IUDGriseofulvin---------------OCPRifampicin------------------OCPTetracycline----------------OCPSulphonamides-------------OCP

Interference with Conception

Cyclophosphamide

Methotrexate

Gestation (2- 2.5 wks)DRUG

Gestation (3- 8 wks)

Differentiated Cells

Congenital Anomalies

Normal Embryo

DRUG

Second TrimesterMaturation of

organ systems

Prolonged exposure to medication

e.g. Fetal hypothyroidism (iodides)

Teeth d’coloration (tetracycline)

Fetal drug metabolism slowerthan maternal

Third Trimester (Near delivery)

Nonteratogenic conditions

Sulphonamides (risk in premature

infants)

NSAIDSPersistent fetal circulationOligohydramnios

Absolutely Contraindicated Drugs

Category XRetinoidsEstrogensFinasterideFluorouracilMethotrexateStanozololThalidomide

Category DAzathioprineAspirinBleomycinColchicineCyclophosphami

deTetracyclinePotassium iodide

Category N

Griseofulvin

Spironolactone

SAFETY OF DRUGS IN PREGNANCY

Itching in Pregnancy

P.U.P.P.P.

Papular Dermatitis

Progesterone Induced Folliculitis

Atopic Eruption of Pregnancy

Cholestatic Pruritus

Herpes gestationis(Pemphigoid gestationis)

AntihistaminesChlorpheniramine (B)Cyproheptadine (B)Diphenhydramine (B)Cetrizine (B), Hydroxyzine (N)

(except 1st trimester)Loratidine (B)Fexofenadine (C )Leukotriene inhibitors – Montelukast

(Cat B)

Antibacterials

TOPICAL SYSTEMICBacitracin PenicillinsMupirocin CephalosporinsPolymyxin B ErythromycinSulphonamides AzithromycinSulphur/ResorcinolRetapamulin

ANTIBIOTIC CATEGORYFluroquinolones CSulphonamides CTetracyclines DFucidic acid/ Na-fusidate

C

TOPICAL ANTIFUNGALS

Category DrugB Clotrimazole, Naftifin,

Nystatin, Oxiconazole, Terbinafin

C Miconazole, Ketoconazole, Sulconazole, Butoconazole, Se-sulphide

C SertaconazoleC EberconazoleC LulliconazoleC Amorolfine

Systemic Antifungals

Category

Drug

B Nystatin, Terbinafine

C Fluconazole, Itraconazole, Ketaconazole

D VoriconazoleN Griseofulvin

AntiviralsAcyclovir,Valacyclovir,Famcyclovi

r =B

Cidofovir = C

Ganciclovir = C

Foscarnet = C

Acne/ Rosacea

Topical

Category

Drug

BClindamycin, Erythromycin, Azithromycin, Azelaic acid, Metronidazole

C Benzoyl peroxide, Adapalene, Tretinoin

X Tazarotene

Systemic

Category

Drug

B Erythromycin, Azithromycin

C SulphonamidesD TetracyclineX Isotretinoin

Systemic RetinoidsSpontaneous abortions

Stillbirths

Malformations – Cranial, Cardiovascular, CNS defects

“iPledge” RequirementsCompulsory registration of

Prescribers/Patients/Pharmacists

Information recorded Confirmation of pt counseling Contraception methods utilized Pregnancy test result

Female of childbearing potential: “non menopausal female who has not had a hysterectomy, bilateral oophorectomy or medically documented ovarian failure”

Telogen effluvium : Post partum hair shedding

Minoxidil (Cat.C):N/R in pregnancy/lact.

Antiscabetics & Pediculocides

Category

Drug

B Permethrin, Malathion, Lindane, Sulphur

C Crotamiton, Ivermectin

Genital Herpes (HSV) In Pregnancy

Acyclovir/ Famciclovir/ Valacyclovir

Molluscum Contagiosum

Cryotherapy, TCA, Surgical Excision

• Cryotherapy• TCA• Surgical Excision

HPV Infections

• Podophyllin- X

• Podophyllotoxin- C

• Imiquimod- C

HPV Infections (cont)

Syphilis

Benzathine Penicillin is T/t of Choice

HIV in Pregnancy

Efavirenz, Delavirdine - C/I d/t teratogenicity

Other ART drugs considered safe

Herpes gestationis : Pemphigoid GestationisBullous Pemphigoid of Pregnancy

Impetigo Herpetiformis

Systemic CorticosteroidsPreg Cat C “Therapeutic doses of cortisone during

pregnancy are unlikely to pose substantial teratogenic risk but data insufficient”

Animals studies- cleft lip/palate, placental insufficiency, spontaneous abortion, stillbirth, IUGR

Fetal HPA axis suppression near deliveryDoses > 10mg/d throughout preg a/w LBW,

hypertension & cardiovascular mortalityPrednisolone inactivated by placenta- DOC

Topical Steroids

Preg Cat ‘C’Use over limited period - not a/w

adverse effectsLarge amounts used over extensive

areas - risk of LBWFluorinated steroids should be

avoided

BiologicalsEtanercept, Infliximab, Adalimumab- Cat

‘B’

ImmunomodulatorsTacrolimus, Pimecrolimus, Cyclosporin,

MMF, Imiquimod - Cat ‘C’Interferons – Cat ‘C’

Vit. D AnaloguesPreg. Cat ‘C’

Leprosy in PregnancyDapsone

Cat ‘C’ 3rd Trimester- Neonatal hemolysis

and methemoglobinemia Folic acid 5mg/d

Rifampicin

Cat ‘C’ 1st Trimester- very high doses : teratogenic in

animals 3rd Trimester- increased risk of neonatal bleeding

Clofazimine Cat ‘C’ Brownish discoloration

Fluroquinolones & Minocycline - C/I

Clarithromycin- Safe

Lepra Rections

Systemic steroids

NSAIDS - Paracetamol, Ibuprofen (avoid preconception & 3rd trimester), Aspirin

Chloroquine/HCQS- Cat ‘C’

Colchicine- Cat ‘C’

Thalidomide - Cat ‘X’

Phototherapy & Photo-chemotherapy

PUVA- NR

NBUVB- Safe

Local anaestheticsLidocaine – B

Prilocaine – B

SUMMARY

Drugs in Pregnancy

Drugs in Pregnancy

LACTATIONControversies among various

sourcesBest sources: AAP and WHOSafe in pregnancy but not during

lactation: Eg: 1st gen.antihistaminicsSafe in lactation but not during

pregnancy: Eg: Topical Retinoids

FDA Lactation Drug Risk Categories

Discontinue “ A decision should be made

whether to discontinue the drug taking into account importance of drug to mother”

Caution “ Advised if drug is absorbed &

excreted into human breast milk & does not have known adverse reactions or tumorigenic potential”

Adverse Effects in InfantsOccur during first 6 mths of life

Sedation – 1st gen. antihistamines

Neurotoxic effects

Diarrhoea

Teratogenic drugs (Cat. D & X) contraindicated

Safe Drugs during Lactation1. Analgesics – Paracetamol2. Antibacterials – Bacitracin, Penicillins Macrolides, Cephalosporins, 3. Antifungals: Topical- Ciclopirox, Clotrimazole, Miconazole,Oxiconazole, Terbinafine (except on nipple) Systemic- Terbinafine, Fluconazole (single

dose)4. Antivirals – Acyclovir,

Famcyclovir,Valacyclovir

Safe Drugs during Lactation (cont)

5.Antiscabetics – Crotamiton, Permethrin & Lindane (controversial)

6. Antihistaminics – Loratidine, Fexofenadine

7. Corticosteroids: Oral- use Prednisolone, avoid nursing

x 4h Topical- avoid use over nipple/areola

8. Antiacne – Adapalene, BP, Tretinoin, Azelaic acid9. Calcipotriene

THANK YOU