PRESCRIBING IN PREGNANCY

Dr Vasudha
Belgaumkar
Associate Professor
Dept. of Dermatology
BJGMC 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
D
C
B
A
N

Contraindicated in pregnancy
Positive evidence for risk to fetus
Risk cannot be r/o.Human studies
lacking
No risk to human fetus
Controlled studies no fetal risk
No category assigned

Sources for Information

WHO
TERIS
USP-DI
Reproductive

toxicology service
AAP (lactation)
Briggs GG et al

Before Conception
Contraceptive

Interference

failure

with conception

Contraceptive Failure
Azathioprine-------------- IUD
NSAID---------------------IUD
Griseofulvin---------------OCP
Rifampicin------------------OCP
Tetracycline----------------OCP
Sulphonamides-------------OCP

Interference with
Conception
Cyclophosphamide
Methotrexate

Gestation (2- 2.5 wks)

DRUG

Gestation (3- 8 wks)

DRUG

Differentiated
Cells

Congenital
Anomalies

Normal Embryo

Second Trimester
Maturation of
organ
systems

Fetal drug
metabolism slower
than maternal

Prolonged exposure to
medication
e.g. Fetal hypothyroidism
(iodides)
Teeth dcoloration (tetracycline)

Third Trimester (Near

delivery)
Nonteratogenic
conditions
Sulphonamides

(risk in

premature
infants)

NSAIDS
Persistent

fetal circulation
Oligohydramnios

Absolutely Contraindicated
Drugs
Category X
Retinoids
Estrogens
Finasteride
Fluorouracil
Methotrexate
Stanozolol
Thalidomide

Category D
Azathioprine
Aspirin
Bleomycin
Colchicine
Cyclophosphami

de
Tetracycline
Potassium 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)

Antihistamines
Chlorpheniramine

(B)
Cyproheptadine (B)
Diphenhydramine (B)
Cetrizine (B), Hydroxyzine (N)
(except 1st trimester)
Loratidine (B)
Fexofenadine (C )
Leukotriene inhibitors Montelukast
(Cat B)

Antibacterials
TOPICAL

SYSTEMIC

Bacitracin

Penicillins

Mupirocin

Cephalosporins

Polymyxin B

Erythromycin

Sulphonamides

Azithromycin

Sulphur/Resorcinol
Retapamulin

ANTIBIOTIC

CATEGORY

Fluroquinolones C
Sulphonamides

Tetracyclines

Fucidic acid/
Na-fusidate

TOPICAL ANTIFUNGALS

Category

Drug

Clotrimazole, Naftifin,
Nystatin, Oxiconazole,
Terbinafin

Miconazole, Ketoconazole,
Sulconazole, Butoconazole,
Se-sulphide

Sertaconazole

Eberconazole

Lulliconazole

Amorolfine

Systemic
Antifungals
Categor
y

Drug

Nystatin, Terbinafine
Fluconazole,
Itraconazole,
Ketaconazole

Voriconazole
Griseofulvin

Antivirals
Acyclovir,Valacyclovir,Famcyclovi

r =B
Cidofovir

=C

Ganciclovir
Foscarnet

=C

=C

Acne/ Rosacea

Topical
Categor
y
B

C
X

Drug
Clindamycin,
Erythromycin,
Azithromycin, Azelaic
acid, Metronidazole
Benzoyl peroxide,
Adapalene, Tretinoin
Tazarotene

Systemic
Categor
Drug
y
B
Erythromycin,
Azithromycin
C
Sulphonamides
D

Tetracycline

Isotretinoin

Systemic Retinoids
Spontaneous

abortions

Stillbirths
Malformations

Cranial,
Cardiovascular, CNS defects

iPledge Requirements
Compulsory

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

Categor
Drug
y
B
Permethrin, Malathion,
Lindane, Sulphur
C
Crotamiton, Ivermectin

Genital Herpes (HSV) In Pregnancy

Acyclovir/ Famciclovir/ Valacyclovir

Molluscum Contagiosum

Cryotherapy, TCA, Surgical Excision

HPV Infections

Cryotherapy
TCA
Surgical Excision

HPV Infections (cont)

Podophyllin- X
Podophyllotoxin- C
Imiquimod- C

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 Gestationis

Bullous Pemphigoid of Pregnancy

Impetigo Herpetiformis

Systemic Corticosteroids
Preg

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 delivery
Doses > 10mg/d throughout preg a/w LBW,
hypertension & cardiovascular mortality
Prednisolone inactivated by placenta- DOC

Topical Steroids

Preg

Cat C
Use over limited period - not a/w
adverse effects
Large amounts used over extensive
areas - risk of LBW
Fluorinated steroids should be
avoided

Biologicals
Etanercept, Infliximab, Adalimumab- Cat
B
Immunomodulators
Tacrolimus, Pimecrolimus, Cyclosporin,
MMF, Imiquimod - Cat C
Interferons Cat C
Vit. D Analogues
Preg.

Cat C

Leprosy in Pregnancy
Dapsone

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 -

Clarithromycin-

Safe

C/I

Lepra Rections
Systemic

steroids

NSAIDS

- Paracetamol, Ibuprofen (avoid

preconception & 3rd trimester), Aspirin

Chloroquine/HCQSColchicine-

Cat C

Cat C

Thalidomide

- Cat X

Phototherapy & Photochemotherapy

PUVA-

NR

NBUVB-

Safe

Local anaesthetics
Lidocaine

Prilocaine

SUMMARY

Drugs in Pregnancy

Drugs in Pregnancy

LACTATION
Controversies

among various

sources
Best sources: AAP and WHO
Safe in pregnancy but not during
lactation:
Eg: 1st gen.antihistaminics
Safe 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 Infants

Occur during first 6 mths of life
Sedation

1st gen. antihistamines

Neurotoxic

effects

Diarrhoea
Teratogenic

drugs (Cat. D & X)

contraindicated

Safe Drugs during Lactation

1. Analgesics Paracetamol
2. 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 acid
9. Calcipotriene

THANK YOU