INTRODUCTION
 The safety of approximately 50 % of medications
for the mother and fetus remains unknown
 Pharmacokinetics are profoundly affected by
pregnancy associated physiologic changes and
dose adjustments are sometimes necessary for
optimal clinical outcome
Teratogens
 A substance, organism, physical agents or
deficiency state capable of inducing abnormal
structure or function such as:
 Gross structural abnormalities
 Functional deficiencies
 Intrauterine growth restriction
 Behavioral aberrations
 Demise
Current Categories for
Drug Use in Pregnancy
 Category A :
Adequate, well-controlled studies in pregnant
women have not shown an increased risk of
fetal abnormalities.
Examples:
 Magnesium sulphate
 Levotyroxine
 vitamins
Current Categories for
Drug Use in Pregnancy
Category B :
 Animal studies have revealed no evidence of harm to
the fetus, however, there are no adequate and wellcontrolled studies in pregnant women.
or
 Animal studies have shown an adverse effect, but
adequate and well-controlled studies in pregnant
women have failed to demonstrate a risk to the fetus
Examples:
 Amoxiciliin
 Amoxicillin + Clavulanic acid
 Cefotaxime
 Methyl dopa
 Metronidazole
 Erythromycin
Current Categories for
Drug Use in Pregnancy
Category C:
 Animal studies have shown an adverse effect
and there are no adequate and well-controlled
studies in pregnant women.
or
 No animal studies have been conducted and
there are no adequate and well-controlled
studies in pregnant women
Examples:
 Diclofenac
 Rifampicin
 Fluoroquinolones
 Aminoglycosides
 Glyburide
 Beta blocker
 Calcium channel blocker
Current Categories for
Drug Use in Pregnancy
Category D:
 Studies, adequate well-controlled or
observational, in pregnant women have
demonstrated a risk to the fetus.
However, the benefits of therapy may
outweigh the potential harm
Examples:
 Tetracyclines
 Phenytoin
 Valproic acid
 Carbamazepine
 ACE inhibitors
 Litium
Current Categories for
Drug Use in Pregnancy
Category X:
 Studies, adequate well-controlled or
observational, in animals or pregnant women
have demonstrated positive evidence of fetal
abnormalities. The use of the product is
contraindicated in women who are or may
become pregnant.
Examples:
 Thalidomide
 Oral contraceptive pills
 Misoprostol
DRUGS USED COMMONLY IN PREGNANCY
 ANTIBIOTICS:
 Cephalosporins
 Fluoroquinolones
 Macrolides
 Aminoglycosides
 Miscellaneous
CEPHALOSPORINS
(Eg: Ceftriaxone, Cefixime, Cefotaxime)
Category B in pregnancy
 Cross the placenta during pregnancy
 Some reports of increased anomalies with specific
cephalosporins (cefaclor, cephalexin, cephradrine)
 Primarily cardiac and oral cleft defects
Lactation
 Excreted into breastmilk in low concentrations
 Considered compatible with breastfeeding
FLUOROQUINOLONES
(Eg: Ciprofloxacin, Norfloxacin)
Pregnancy Category C
 Not recommended in pregnancy
 Cartilage damage in animals
 Safer alternatives usually exist
Lactation
 Excreted into breastmilk
 Limited human data
 compatible with breastfeeding
MACROLIDES
(Eg: Azithromycin, Clarithromycin, Erythromycin)
Pregnancy Categories B/C/B
 Cross the placenta in low amounts
 Limited data with azithromycin and clarithromycin
Lactation
 Erythromycin compatible
 Others probably compatible
AMINOGLYCOSIDES
(Gentamicin, Amikacin)
 Pregnancy Category C
 Rapidly cross placenta
 Enter amniotic fluid through fetal circulation
 Lactation
 Compatible with breastfeeding
 Not absorbed through GI tract
Tetracyclines
(doxycycline, minocycline, tetracycline)
 Pregnancy Category D
 Can cause problems with teeth and bone and other
defects/effects
 Have been linked to maternal liver toxicity
 Lactation
 Compatible with breastfeeding
 Serum levels in infants undetectable
MISCELLANEOUS ANTIBIOTICS
 Clindamycin
 Pregnancy Category B, commonly used
 Lactation – Compatible
 Metronidazole
 Pregnancy Category B, carcinogenic in animals, avoid
in 1st trimester if possible
 Lactation – hold feeds for 12-24hrs afterward
MISCELLANEOUS ANTIBIOTICS
 Vancomycin
 Pregnancy Category B, compatible
 Lactation – likely compatible, not absorbed
 Nitrofurantoin
 Pregnancy Category B, possible hemolytic anemia
with use at term
 Lactation – Compatible, avoid with G-6-PD deficiency
MISCELLANEOUS ANTIBIOTICS
 Trimethoprim
 Pregnancy Category C, potentially
problematic early in pregnancy
 Lactation – Compatible as combination
drug
Antivirals
(acyclovir, famciclovir, valacyclovir)
 Pregnancy Category B
 Acyclovir and valacyclovir readily cross the
placenta
 Can be used for HSV treatment and suppression
 Lactation
 Acyclovir and valacyclovir are compatible
 Famciclovir should be avoided
Antiretrovirals/NRTI
(abacavir, didanosine (ddI), emtricitabine (FTC))
 Pregnancy Categories C/B/B
 Maternal benefit usually outweighs fetal risk
 Cross the placenta
 Limited data with each do not show increased
risk of anomalies
 Didanosine has been associated with severe
lactic acidosis w/ or w/o pancreatitis
Antiretrovirals/NRTI
(lamuvidine (3TC), stavudine (d4T))
 Pregnancy Category C
 Maternal benefit usually outweighs fetal risk
 Cross the placenta by simple diffusion
 Data with lamivudine show no increased risk of anomalies
 Stavudine has been associated with severe lactic acidosis
w/ or w/o pancreatitis
 All NRTIs have been possibly linked to mitochondrial
dysfunction postnatally
Antifungals/Azoles
(fluconazole, itraconazole, ketoconazole, posaconazole,
voriconazole)
 Pregnancy Categories C/C/C/D
 Likely cross placenta
 Fluconazole > 400mg/day seems to be associated
with cranio-facial abnormalities
 Itraconazole appears to have low risk
 Ketoconazole can impair testosterone and cortisol
synthesis
 No data in humans is available for voriconazole,
increased risk in animals
Antifungals/Azoles
(fluconazole, itraconazole, ketoconazole, posaconazole,
voriconazole)
 Lactation
 Fluconazole is compatible
 Itraconazole could concentrate in milk and
body tissues, not recommended
 Ketoconazole is compatible
 No data with voriconazole, not recommended
Migraine Headache Therapy
 Triptans
 Ergots
 Caffeine
Triptans (5-HT1 agonists)
 Pregnancy Category C
 Limited human data exists, sumatriptan has been
associated with VSDs in several cases
 No data available in humans for almotriptan, eletriptan,
frovatriptan, or zolmitriptan
 Limited human data exists with naratriptan and
rizatriptan, although animal data indicates moderate risks
 Pregnancy registry available for exposures
Triptans (5-HT1 agonists)
 Lactation
 Cross into breastmilk and may concentrate
 No reports of human lactation with almotriptan,
frovotriptan, naratriptan, rizatriptan, or zolmitriptan
 Sumatriptan is compatible
 Eletriptan is likely compatible with low concentrations
Ergots
(Dihydroergotamine, ergotamine)
 Pregnancy Category X
 Oxytocic properties could cause IUGR by vascular
disruption or increased uterine tone
 Early exposure appears safe, not teratogens
 Chronic exposure is contraindicated
 Lactation
 Contraindicated
ANTICONVULSANTS
HYDANTOIN AGENTS
Category D
 Hydantoin agents (Phenytoin) are teratogens
long recognised for constellation of congenital
anomalies known as fetal hydantoin syndrome
 The syndrome consists of craniofacial
abnormalities , mental deficiency , hypoplasia
of phalanges
ANTICONVULSANTS
CARBAMAZEPINE:
Category D
 Was considered relatively safe for use during pregnancy
but recent FDA reports suggest increased risk of neural
tube defects with carbamazepine too and a pattern of
malformations similar to phenytoin
 Increases the risk facial dysmorphology, neural tube
defects, cardiovascular defects, and urinary tract defects.
ANTICONVULSANTS
VALPROIC ACID:
Category D
 It is commonly used for petit mal seizures
 1 to 2 % risk of neural tube defects with use in
pregnancy
 atrial septal defect, cleft palate, hypospadias,
polydactyly, and craniosynostosis.
Antidepressants
 Recent publications have implicated some of the SSRIs
administered in the last trimester with postnatal
neurobehavioral effects that are transient and whose
long-term effects have not been determined. Firsttrimester exposures to some SSRIs have been reported to
increase the risk of some congenital malformations,
predominantly congenital heart disease. The results have
not been consistent, but warnings have been issued.
Antituberculous therapy
 Isoniazid and paraaminosalicylic acid have an
increased risk for some CNS abnormalities.
Corticosteroids
 High exposures administered systemically have a
low risk for cleft palate in some studies, but the
epidemiologic studies are not consistent.
Methimazole
 Aplasia cutis has been reported to be increased
in mothers administered this drug during
pregnancy*
Warfarin and warfarin derivatives
 Early exposure during pregnancy can result in
nasal hypoplasia, stippling of secondary
epiphysis, intrauterine growth restriction. Central
nervous system malformations can occur in late
pregnancy exposure because of bleeding.
NSAIDs and aspirin
 Aspirin has been used for years in patients requiring NSAID therapy
during pregnancy. Salicylates readily cross the placenta, but a 2002
meta-analysis did not find evidence of an overall increase in risk of
congenital defects associated with first trimester use of aspirin
.Although some case-control studies have reported associations
between human congenital malformations and aspirin use early in
gestation, no consistent adverse outcome attributable to drug use
has been observed.

The NSAIDs and salicylates are considered by the FDA as category C drugs in terms of
the risks associated with their use during the first two trimesters .A number of the
NSAIDs are labeled as category D drugs from week 30 onwards, and high-dose aspirin
is considered a category D medication during the third trimester
 However, third trimester use of these agents may pose greater risk.
The inhibition of prostaglandin synthesis by NSAIDs or by high-dose
aspirin therapy in the third trimester has the potential for causing
premature closure of the ductus
arteriosus; indomethacin and ibuprofen appear to have much
stronger ductal effects than aspirin .High-dose aspirin near delivery
may increase the risk of fetal or neonatal bleeding or bruising
although data are inconsistent
PROSTAGLANDINS
 They are synthesised from essential fatty acids
 PGF2a promotes myometrial contractility , is
produced mainly from decidua
 PGE2 helps cervical maturation / ripening , is
mainly produced from amnion
 They also sensitise myometrium to oxytocin
 Commonly used for induction of labour
PROSTAGLANDINS
PGE1 – Misoprostol: (Category X)
 PGE1 promotes cervical ripening and myometrial
contractility is increased
 Transvaginally used for induction of labour
 Failure of induction is less
 Can be used per rectally /orally also
 Incidence of tachysystole is high and thus should not
be used in cases with previous ceasarean birth
ANTIHYPERTENSIVES
METHYL DOPA:
Category B
 It is the drug of first choice in pregnancy
 Has central and peripheral anti adrenergic action
 Safe for both mother and fetus
 Postural hypotension is a common side effect
 May be given orally or i.v
 Doses start from 25o mg bd to 500 mg four times a day
ANTIHYPERTENSIVES
NIFEDIPINE:
 Cause direct arteriolar vasodilatation by
inhibition of slow calcium channels
 Flushing , hypotension , headache , tachycardia
are side effects noted
ANTIHYPERTENSIVES
LABETALOL:
 Has combined alpha and beta adrenergic
blocking actions
 Can be used orally and as iv infusion
 Efficacy and safety appears to be equal to
methyl dopa
 Dose is 100 mg twice a day
ANTIHYPERTENSIVES
ACE INHIBITORS:
Category C or D
 Not used in pregnancy as studies show
increased risk of oligohydramnios , neonatal
anuria , renal anomalies and nephrotoxicity
when used in 2 nd and 3 rd trimesters
 Thus considered human teratogens
ANTIHYPERTENSIVES
SODIUM NITROPRUSSIDE:
 It is used to treat serious , life threatening
hypertension
 Animal studies have shown fetal cyanide toxicity
but human studies have not proved the same
 Nonetheless , it is avoided in preganancy and is only
used as last resort
ANTIHYPERTENSIVES
MAGNESIUM SULPHATE:
Category A
 Mechanism of action :
 It decreases acetycholine release from nerve
endings and reduces motor end plate sensitivity to
acetylcholine
 It blocks calcium channels and causes vasodilation
 Can be given by Pritchard regime or
Zuspan regime
 Pritchard Regime:
4 gm iv slowly followed by 5 gm in each buttock
deep im -- loading dose
5 gm deep im 4 hourly in alternate buttock
 Indications:
 In eclampsia , as an anticonvulsant
 As a tocolytic
 Contraindications
 In patients with renal impairment
 Dosage:
 For I.V infusion , 50% solution must be diluted to 20 %
before administration
 50% solution (undiluted) is given for intramuscular
injections
 It is relatively safe . Muscular paresis , respiratory
failure and renal effects on mother are known side
effects
 Thus deep tendon reflexes, respiratory rate and
urine output monitoring is essential in a patient
receiving Magnesium Sulpahate
 Has no harmful effects on fetus though neonatal
respiratory depression may be seen
TOCOLYTICS
BETAMIMETICS:( Terbutaline , Isoxsuprine)
 Category C
Mechanism of action:
 They activate intracellular enzymes and reduce
intracellular free calcium which leads to reduced
interaction of actin and myosin
Dosage:
 Terbutaline can be subcutaneously 0.25 mg 6
hourly or orally 0.5 mg 6 hourly
 Isoxsuprine is given either as intravenous
infusion drip or intramuscularly(10mg 6 hourly)
or orally (10 mg 6/8 hourly)
 Contraindications :
 Cardiac arrhythmias
 Poorly controlled diabetes mellitus
 Poorly controlled thyroid disorders
 Maternal side effects are headache ,
palpitations , pulmonary edema , hyperglycemia
and hypotension
 Fetal tachycardia , heart failure may be seen
 INDOMETHACIN AND CALCIUM CHANNEL
BLOCKERS :
 They are also used commonly for tocolysis
 Indomethacin may cause gastric disturbances in
mother
 Calcium channel blockers may cause headache ,
flushing
 Both cause no known fetal harm
OXYTOCIN
 Mechanism of action:
 It acts through calcium channels to initiate
myometrial contractions
 Also stimulate amniotic and decidual
prostaglandin production
OXYTOCIN
Routes of administration:
 Can be given intramuscularly or by controlled
intravenous infusion
 It is also available as nasal solution , buccal
tablets
OXYTOCIN
Indications:
 Induction of labour
 Augmentation of labour
 In active management of third stage, as an
alternative to methergin
 To control postpartum hemorrhage
OXYTOCIN
Contraindications:
 Obstructed labour
 Malpresentations
 Contracted pelvis
 History of previous Caesarean
section/hysterotomy (relative contraindication)
OXYTOCIN
Maternal side effects:
 Uterine hyperstimulation (sometimes rupture)
 Water intoxication due to its antidiuretic effect
 Hypotension
OXYTOCIN
Fetal side effects:
 Fetal distress , fetal hypoxia or even fetal death
may occur due to hyperstimulation
ERGOT DERIVATIVES
METHERGIN: (Category X)
Mechanism of action:
 Acts directly on myometrium and cause tetanic
uterine contractions
Route of administration:
 Parenterally – 0.2 mg ampoules available
 Orally – 0.5 or 1 mg tablets available
ERGOT DERIVATIVES
Indications:
 Therapeutic:
 To stop atonic uterine bleeding following delivery
or abortion
 Prophylactic :
 Should be only used in second stage of labour
after delivery of anterior shoulder or following
delivery of baby
ERGOT DERIVATIVES
Contraindications:
 In cardiac diseases
 Rh negative pregnancies
 Severe pre-eclampsia/eclampsia
IRON DEXTRAN
 It is intramuscularly used iron
preparation for treatment of
iron deficiency anemia
 1 ml of iron dextran contains
50 mg elemental iron
 Oral iron to be stopped 24 hour
before therapy to avoid
reactions
IRON DEXTRAN
 Mode of administration:
 Dose to be given is initially calculated
 Initial test dose is given
 This is followed by daily or alternate day
injections given deep im by Z technique
IRON DEXTRAN
Drawbacks:
 Injections are painful
 May cause staining of skin
 Allergic reactions , though rare , may occur
 Abscess formation over injection site may occur
IRON DEXTRAN
Indications:
 Iron deficiency anemia , when oral iron therapy
is unsatisfactory or not tolerated
Contraindications:
 Anemia other than iron deficiency
 Hypersensitivity to the product
Ionizing radiationRadiation
 Ionizing radiationRadiation exposure above a
threshold of 20 rad (0.2 Gy) can increase the risk
for some fetal effects such as microcephaly or
growth retardation, but the threshold for mental
retardation is higher.
Some common teratogenic medications
include:
 Angiotensin converting enzyme inhibitors.
 Anticonvulsant agents
 Antineoplastic agents
 Thalidomide, retinoic acid, methylene
blue, misoprostol, penicillamine, fluconazole, lit
hium, isotretinoin, and acitretin
Some common teratogenic medications include:
 Retinoic acid is highly teratogenic in the first trimester of pregnancy,
leading to spontaneous abortions and fetal malformations,
including microcephaly and cardiac anomalies . At doses of only
several times the RDA , many animal models as well as human
studies have shown high incidence of birth defects in mothers who
ingested therapeutic doses of retinoic acid for dermatological uses .
A safe upper limit for vitamin A intake has been recognized at about
800 to 10,000 IU/day . Acitretin should not be used by women who
want to become pregnant as conception is contraindicated for at
least three years after discontinuation.
Some common teratogenic medications include:
 Androgenic agents, such as testosterone or danazol, do
not cause malformation, but can virilize a female fetus.
Cocaine induced vasoconstriction of uterine vessels is
one mechanism for fetal damage from this substance .
Infants whose mothers consume alcohol during
pregnancy can have fetal alcohol effects (FAE), alcoholrelated birth defects (ARBD), fetal alcohol syndrome, or
they may be normal.
Some common teratogenic medications include:
 Folicacid antagonists(eg, trimethoprim, triamterene, car
bamazepine, phenytoin, phenobarbital, primidone, met
hotrexate) increase the risk of neural-tube defects and
possibly cardiovascular defects, oral clefts, and urinary
tract defects and placenta-mediated adverse pregnancy
outcomes, including preeclampsia, placental abruption,
fetal growth restriction, and fetal death .
 Specific information on the fetal and neonatal risks of maternal drug
ingestion during pregnancy and lactation are available from several
resources , including:
 www.perinatology.com/exposures/druglist.htm
 www.reprotox.org/ (requires subscription)
 www.OTISpregnancy.org
 file://depts.washington.edu/terisweb/teris/ (requires subscription)
 www.motherisk.org/women/drugs.jsp
 UpToDate drug information database
Antibiotics in Pregnancy
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Penicillins
Erythromycin
Cephalosporins
Nitrofurantoin
Metronidazole
Trimethoprim
Sulpha drugs
Chloramphenicol
Tetracycline
Gentamicin
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A
A
A
A
B2
B3
C
A
D
D
Anti-malarial drugs for
Pregnancy
 Chloroquine
 A
 Quinine
 D
 Paludrine
 B2
 Maloprim, Daroprim
 B3
 Larium
 B3
 Fansidar
 D
 Doxycycline
 D
HAART drugs for Pregnancy
 AZT
 B3
 Lamivudine
 B3
 Nevirapine
 B3
 3TC
 B3
 Abacavir
 B3
Anti-emetics for Pregnancy
 Pyridoxine
 A
 Diphenhydramine
 A
 Metoclopromide
 A
 Hyoscine
 B2
 Ondansetron
 B1
 Promethazine
 C
 Prochlorperazine
 C
Antihypertensive drugs in
Pregnancy
 Aldomet
 A
 Hydralazine
 C
 Beta blockers
 C
 Ca channel blockers
 C
 Thiazides
 C
 ACE Inhibitors
 D
 ↑risk of CNS & CHD defects 3-
Analgesic Drugs for
Pregnancy
 Paracetamol
 A
 Codeine
 A
 Aspirin
 C
 Narcotics
 C
 NSAIDs
 C
 Have the potential to cause
in utero closure of the
ductus arteriosus >34w
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