Drugs in lactation and pregnancy

33
By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 1 In the name of God The Safety of Dermatological Drugs During Pregnancy & Lactation Dr.Mohammad Baghaei (Pharm .D), Dr. Hamidreza Zolfaghari(MD), Dr. Hamidreza Mohseni (MD), Dr.Aliasghar Aliyari (MD), Dr. Ali Abedi (Pharm .D), Dr. Alireza Khosravi (MD)

Transcript of Drugs in lactation and pregnancy

Page 1: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 1

In the name of God

The Safety of Dermatological Drugs

During Pregnancy & Lactation

Dr.Mohammad Baghaei (Pharm .D), Dr. Hamidreza Zolfaghari(MD),

Dr. Hamidreza Mohseni (MD), Dr.Aliasghar Aliyari (MD),

Dr. Ali Abedi (Pharm .D), Dr. Alireza Khosravi (MD)

Page 2: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 2

INCLUDES:

Introduction

Dermatological drugs during Pregnancy

FDA category

Dermatological drugs during Lactation

References

Page 3: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 3

Introduction

Treatment of many dermatologic conditions is elective. Some drugs which used by the

dermatologist for the patient who is pregnant or lactating may have potentially harmful

effects on the mother and fetus or nursing infant. Likewise, not every pregnancy (in the

absence of drug therapy) results in the delivery of a perfectly healthy baby, and physicians

are anxious to have litigation about prescribe a medication that might possibly have

contributed to the problem. For this reason, a general reluctance exists among physicians

to prescribe medications during pregnancy and lactation. There are, however, drugs for

which use during pregnancy and lactation have no apparent contraindication. It may be

have both interest and comfort to the clinician and patient to become familiar with this

select list of drugs.

This book identifies contraindications of various drugs with the possible extent information which

currently available.

Page 4: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 4

Pregnancy:

During the first trimester drugs may produce congenital malformations (teratogenesis),

and the period of greatest risk is from the third to the eleventh week of pregnancy. During

the 2nd and 3rd trimesters drugs may affect the growth and functional development of the

fetus or have toxic effects on fetal tissues. Drugs given shortly before term or during

labour may have adverse effects on labour or on the neonate after delivery.

The natural occurrence of fetal abnormalities in 1-2% of human pregnancies makes

interpretation of case reports difficult. Data from animal teratogenicity studies are

extremely valuable; however, they are not always applicable to humans. Drugs that are

teratogenic in animals may be safe in humans and versa. One factor which makes the

gathering of appropriate information on the effect of drugs in pregnancy very difficult is

that the manufacturers of many of the drugs carry a blanket warning on use in pregnancy

in their product information literature.

If treatment is clearly indicated and the patient is willing to accept potential risks but the

safety of the treatment in pregnancy has not been established, then the first approach

should be topical therapy when possible.

Page 5: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 5

The term "Pregnancy Risk Factor" followed by letter A, B, C, D or X signifies a pregnancy

category. The FDA established these five categories to indicate the potential of a systemically

absorbed drug for causing birth defects. The categories are determined by the reliability of

documentation and the risk to benefit (risk: benefit) ratio.

Pregnancy category X is particularly distinguished in that if any data exists that may

implicate a drug as a teratogen (potentially causing birth defects) and the risk to benefit ratio

is clearly negative, the drug is contraindicated (prohibited from use) during pregnancy.

Sometimes a drug taken by a woman during pregnancy may enter a fetus, causing damage or

birth defects. The risk of damage to the fetus is the greatest in the first few weeks of

pregnancy, when major organs are developing. However, researchers do not know if taking

medicines during pregnancy may also have negative effects on the baby later on.

Introduced in 1979, the pregnancy category of a pharmaceutical agent is an assessment of the

risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during

pregnancy. It does not include any risks given by pharmaceutical agents or their metabolites

that are present in breast milk.

Page 6: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 6

The FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to

be defined as pregnancy category A. As a result of this, many drugs that would be considered

pregnancy category A in other countries are allocated to category C by the FDA.

FDA CATEGORIES

Category A: Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the

first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears

unlikely.

Category B: Either animal-reproduction studies have not demonstrated a fetal risk, but there are

no controlled studies in pregnant women, OR animal-reproduction studies have shown an adverse

effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the

first trimester and there is no evidence of a risk in later trimesters.

Category C: Either studies in animals have revealed adverse effects on the fetus (teratogenic or

embryocidal effects or other) and there are no controlled studies in women, OR studies in women and

Page 7: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 7

animals are not available. Drugs should be given only if the potential benefits justify the potential risk

to the fetus.

Category D: There is positive evidence of human fetal risk, but the benefits from use in pregnant

women may be acceptable despite the risk (e.g. if the drug is needed in a life-threatening situation or

for a serious disease for which safer drugs cannot be used or are ineffective).

Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is

evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in

pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who

are or may become pregnant.

Page 8: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 8

Dermatological drugs in pregnancy:

1. Analgesics, Narcotics & Antipyretics, Anesthetics

General & Local 2. Anthelmintics 3. Anti-Acne products topical 4. Antiamoebics 5. Antibacterials 6. Antidepressants,Antipsychotics,Anxiolytics,Hypnotics

Sedatives 7. Antifungals 8. Antihistamines 9. Anti-mycobacterial 10. Antirheumatic,anti-inflammatory 11. Antiscabietics and Pediculicides 12. Antituberculous Agents 13. Antivirals 14. Contraceptive Agents

Page 9: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 9

15. Cytotoxic Drugs 16. Hormones 17. Vaccines (Live) 18. Vitamins and Minerals 19. Miscellaneous

Page 10: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 11

Analgesics,Narcotics & Antipyretics, Anasethetic General & Local

Adverse effectsFDA Trimester of riskDrugsGroups

categories

With large doses, neonatal respiration depression, hypotonia and bradycardia B3Lidocaeine(topical)

after paracervical or epidural block neonatal methaemoglobinaemia with prilocaine B3Lidocaeine-H(topical)

B3Lidocaeine-p(topical)Anasethetic

Neonatal methaemoglobinaemia B3Prilocaine-F General & Local

C3 Codein

C3Morphine

Respiratory depression in newborns, withdrawal symptoms in neonates of C3Meperidine

dependent mothersC3OxycodoneNarcotics

C3Diphenoxylate

Closure of fetal ductus arteriosus in utero and possibly persistent pulmonary D1,3Aspirin,Salicylates

hypertension of the newborn (occurs with high regular doses) Delayed onset and

increased duration of labour with increased blood loss. Impaired platelet function

and risk of haemorrhage both in newborn and in the mother. kernicterus in

jaundiced neonates.

B3Acetaminophen NSAIDS

Regular use results in closure of fetal ductus arteriosus in utero and possibly B1,3Naproxen

persistent pulmonary hypertension of the newborn. Prolong labour and delay in B1,3Ibuprofen

parturition.C1,3Celeoxib

D1,3Indomethacine

Page 11: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 11

Antihelminitics

Adverse effectsFDA Trimester of riskDrugsGroups

categories

C1Albendazole

Teratogenic in animal studies C1Mebendazole Antihelminitics

C1Thiabendazole

Anti- acne Topical

Adverse effectsFDA Trimester of riskDrugsGroups

categories

It has not shown mutagenicity, teratogenicity, or embryotoxicity in animal but BAzelaic Acid

experience is too limited to assess safety of the drug. Anti-acne

The medication may be systemically absorbed with topical use. Studies in CBenzoyl peroxidetopical

human have not been done . Use during pregnancy is not contraindicated.

A congential anomaly involving the eye has been reported. CAdapalene

It has been associated in case reports with teratogenicity when used during the first trimesterC1,2,3Tretinoin

It has caused retinoid-like anomalies.X1,2,3Tazarotene

Page 12: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 12

Antiamoebics

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Manufacturer advises avoidance of short, high dosage regimensBMetronidazole (ALL FORMS)Antiamoebics

Page 13: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 13

Page 14: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 14

Antibacterial

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Avoid, 8th cranial nerve damage. Risk higher with streptomycin, kanamycin thanC2, 3Gentamycin

gentamicin, tobramycin. Potentially nephrotoxic and ototoxic to fetus.D2, 3StreptomycinAminoglycosides

D2, 3Kanamycin

D2, 3Tobramycin

CCiprofloxacin

Congenital anomailis are inconsistC1,2,3OfloxacinFlouroquinolones

CLomefloxacin

CNalidixic Acid

Maternal hepatotoxicity with large parenteral doses, bone growth disturbance, D2, 3Tetracycline

May induce hypoplasia of the enamel and discoloration of the teeth.D2, 3Minocycline Tetracyclines

D2, 3Doxycycline

B Penicillin G

B Penicillin V Penicillins

Have not been associated with an increased risk of congenital anomalies B Amoxicillin

B Ampicillin

B Cloxacillin

Possible teratogenic risk (folate antagonist). C TrimethoprimTrimethoprim

A large survillance study found an association between congenital B1Cephalexin

malformationsand use of cephalexin ,cefaclor & cephradine during the first B1Cefaclor

trimester of pregnancybut similar findings did not occur with cefadroxil.B1Cephradine

BCefradoxil Cephalosporines

BCefexim

BCefotaxime

BCeftizoxime

BCeftazidime

BCeftriaxone

BCefuroxime

Page 15: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 15

Antibacterial(cont)

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Toxicities that may be observed in the newborn includeC3Sulfamethoxazole Sulfonamides

jaundice and hemolytic anemia. B 3Sulfadiazine

C 3Sulfacetamide

It has not been associated with a reported risk . BAzithromycin Azithromycin

It has not been associated with a reported risk . B ErythromycinMacrolides

It has not been associated with a reported risk . BErythromycin Topical antibacterial

It has not been associated with a reported risk . BMupirocin Agents

It has not been associated with a reported risk . BClindamycin

It has not been associated with a reported risk . BPolymixin B

It has not been associated with a reported risk . BNeomycin

It is thought to pose a potential risk for Kernictures and hemorrhage in B Silver Sulfadiazine

the premature infant or infant with glucose-6-phosphate

dehydrogenes (G6PD)Deficiency.

Page 16: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 16

Antidepressants, Antipsychotics,Anxiolytics&Hypnotics Sedatives

Adverse effectsFDA Trimester of riskDrugsGroups

categories

AVOID, withdrawal effectsin neonates, post partum hemorrhage and hemorrhagicD1,2,3BarbituratesAntidepressants

disease of the newborn, hypotension, reduced respiratory function and hypothermiaAntipsychotics

Neonatal drowsiness, hypotonia and withdrawal symptoms,D1,3BenzodiazepinesAnxiolytics

avoid large doses and regular use.Hypnotics Sedatives

Extrapyramidal effects in neonate occasionally reported.C3Phenothiazines(Trifluprazine)

Occasionally, tachycardia, irritability, muscle spasms, convulsions, D3Tricyclics (Amitriptyline)

urinary retention, withdrawal effects in neonate

Antifungal Drugs

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Adverse fetal effects seen in animals at high doses.C1,2,3Fluconazole

Fetotoxicity and teratogenic in animals.Unrated1,2,3Griseofulvin

Abnormalities of fetal development when given at high doses to pregnant rats C1,2,3Itraconazole

and mice No data available in human pregnancy.

Induces syndactylism in rats at a dose of 80 mg/kgC1,2,3Ketoconazole Antifungal Drugs

May be absorbed if used over large areas of the body.1,2,3Selenium sulfide, topical

It has not been associated with a reported risk . BNystatin

Animal studies evaluating oral terbinafin in pregnancy showed production of benign tumors in rats.BTerbinafin

It is a known teratogen and should be avoided during pregnancy .DVoriconazol

Clotrimazole used during the first trimester of pregnancy as an oral topical treatmentB1Clotrimazol (topical)

of vaginitis has been associated ith a slightly increased risk of congenital

defects in humans in one study.

It has been associated with animal fetotoxicityC1,2,3miconazole

Page 17: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 17

Antihistamins

Adverse effectsFDA Trimester of riskDrugsGroups

categories

It has not been associated with a reported risk . BCetrizine

It has not been associated with a reported risk . BCyproheptadine

It has not been associated with a reported risk . BDiphenhydramine

UnratedDoxepin Antihistamins

Fexofenadine has no human data,and notes that animal studies have shownC1,2,3Fexofenadine

toxicity to the embryo and fetus.

UnratedHydroxyzine

It has been associated with a few adverse outcomes during pregnancy including B1,2,3Loratidine

cleft palate, microtia, microphthalmia,deafness,dysmorphia and diaphragmatic hernia.

Anti-mycobacterial

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Associated with pigmentation of infant's skin C1,2,3Clofazimine Anti-mycobacterial

Page 18: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 18

Antiscabietics and Pediculicides

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Absorption in humans has not been studied. CCrotamiton Antiscabietics

Use of lindane has been controversial, with some reports discouragingandBLindaneand Pediculicides

the use of lindane in pregnancy .

It has not shown teratogenicity in animals.BMalathion

It has not shown teratogenicity in animals.BPermethrin

Antirheumatic,Anti-inflammatory

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Avoid if possible D1,2,3Penicillamine Antirheumatic,

anti-inflammatory

Page 19: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 19

Antivirals

Adverse effectsFDA Trimester of riskDrugsGroups

categories

It has not shown teratogenicity in animals, but causes fetal death, growth BAcyclovir

retardation, and malformations in rats at maternotoxic dose. Use in human

pregnancies has not been associated with adverse fetal effects.

It has not shown teratogenicity in animals, but causes benign tumors in rats. BFamciclovirAntivirals

It has not shown teratogenicity in animals.Bvalacyclovir

Avoid, teratogenic in animal studies Manufacturer recommends avoid unless compelling reasons. C1,3Idoxuridine

Avoid, teratogenic in animal studies Manufacturer recommends avoid unless compelling reasons. C1,3Interferon

Antituberculous Agents

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Embryotoxicity in animals. Increased risk at neonatal bleeding - if given in 3rdC1,2,3RifampicinAntituberculous

trimester. Prophylactic Vitamin K is recommended for mother and newborn infant

if used during the last few weeks of pregnancy

Page 20: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 21

Contraceptives

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Epidemiological evidence suggests no harmful effects on fetus. X1,2,3Oral contraceptives Contraceptives

Cytotoxic Drugs

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Most are teratogenicX1,2,3Cytotoxic DrugsCytotoxic Drugs

Page 21: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 21

Hormones

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Possibility of suppression of the adrenal cortex in the newborn after tong term C2, 3 Corticosteroids,oral

treatment ,in animal studies during pregnancy has been associated with an

increased risk of cleft palate, placental insufficiency, spontaneous abortion

, and growth retardation in utero.

Avoid superpotents, avoid occlusion, avoid large areasC2, 3 Corticosteroids,topical Hormones

Avoid, virilisation of female fetus D1,2,3Androgens(Testosterone)

Avoid, high doses may be teratogenic. Animal studies have shown that high doses x1Progestogens

of progestogens can cause masculinisation of female fetus.

Vaccines (Live)

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Theoretical risk of congenital malformationsUnrated 1Vaccines (Live)Vaccines (Live)

Page 22: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 22

Vitamins and Minerals

Adverse effectsFDA Trimester of riskDrugsGroups

categories

Excessive doses may be teratogenicB(D,X)Vitamin A

May produce neonatal hemolysis, risk of kernicterus in jaundiced infants especially if premature CVitamin K analogues

C Vitamin B- complex

CVitamin B12Vitamins and

CVitamin B1 Minerals

CVitamin B2

CVitamin C

Excessive doses may be teratogenicAVitamin D

A Vitamin E

Miscellaneous

Adverse effectsFDA Trimester of riskDrugsGroups

categories

May be small risk of teratogenesis including increased risk of neural tube defects D1Carbamazepine

High doses cause neurological disturbances in the fetusC1,2,3Chloroquine,Hydroxychloroquine

Teratogenic in animalsCColchicine

Neonatal haemolysis and methaemoglobinaemiaC3Dapsone Miscellaneous

Neonatal hirsutism reported C3Minoxidil

May inhibit labour, teratogenic in animals C3Nifedipine

AVOID, Neonatal death and embryotoxicity have been reportedX1,2,3Podophyllin,topical

Avoid, may cause hypothyroidismD2, 3Potassium iodide,oral

Possible skin absorption of sufficient iodine to affect the fetal thyroidCPovidone-iodine,topical

It is a known carcinogen and mutagen , no studies have been done in human . CCoal Tar

It was embryotoxic, fetotoxic, and carcinogenic in some animal studies.CCyclosporine

Page 23: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 23

Lactation:

Most drugs taken by the nursing mother will be excreted in her milk. Usually the amount is

negligible and the effect on the infant insignificant rarely is it necessary to stop breast feeding due

to the mother's medications.

A good rule to follow is if the drug can safely be given directly to the infant, it is generally safe to

give to the mother during lactation.

To minimize the amount likely to be excreted in breast milk and ingested by the infant, it is

recommended that the dose of a drug is taken 15 minutes after feeding, or 3-4 hours before the

next feed.

Drugs with short acting characteristics or with short elimination half lives are obviously less likely

to cause problems and once or twice daily dosage is preferable to more frequent administration.

All breast fed infants should be monitored for adverse effects of drugs ingested by the mother.

Page 24: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 24

Dermatological drugs during lactation:

1- Analgesic & antipyretic

2- Antihelmintics

3- Antibacterials

4- Antidepressants/Antipsychotics/ Anxiolytics/Hypnotics/Sedatives

5- Antifungals

6- Antiscabetics

7- Antituberculous agents

8- Contraceptives

9- Cytotoxic drugs

10- Hormones

11- Immunosuppressants

12- Vitamins & minerals

13- Miscellaneous

Page 25: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 25

Analgesics & Antipyretics

Adverse effectsDrugsGroups

AVOID -possible risk of Reye's Syndrome. Regular use of high doses could impair platelet function and Aspirin

produce hypoprothrombinaemia if neonatal vitamin K stores are low. Analgesics

Milk levels are similar to maternal plasma levels. One case report of possible indomethacin induced Indomethacin& Antipyretics

seizures in a breast-fed infant.

Regular use of high doses can produce dependence and withdrawal effects.Narcotic analgesics

Antibacterials

Adverse effectsDrugsGroups

Excreted into breast milkClindamycin

Significant amount in milk, may give bitter taste to milk.Metronidazole

Risk of haemolytic anaemia in G6PD deficient babies. Small risk of kernicterus in jaundiced infants.SulfonamidesAntibacterials

& Co-trimoxazole

Remote theoretical possibility of dental staining and inhibition of bone growth.Tetracycline

Page 26: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 26

Antidepressants / Antipsychotics/ Anxiolytics / Hypnotics / Sedatives

Adverse effectsDrugsGroups

AVOID large doses and regular use; drowsiness, lethargy and failure to thrive have been reportedBenzodiazepinesAntidepressants

DrowsinessChloral hydrate Antipsychotics

Monitor infant for excessive drowsiness and for normal growth and developmentPhenothiazinesAnxiolytics /

Hypnotics / Sedatives

Page 27: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 27

Antifungals

Adverse effectsDrugsGroups

Excreted in breast milk. Manufacturer recommends that the mother should not breast feedItraconazole Antifungals

Probably excreted in breast milk. May increase the risk of kernicterus in nursing infants.Ketoconazole

Antihelmintics

Adverse effectsDrugsGroups

Excretion in breast milk is unknown, manufacturer recommends discontinuation of the drug or of nursing.Thiabendazole Antihelmintics

Page 28: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 28

Antimycobacterial

Adverse effectsDrugsGroups

As clofazimine is excreted in breast milk, infant may have skin discoloration from breast-feedingClafazimineAntimycobacterial

Antiscabetics

Adverse effectsDrugsGroups

Amount too small to be harmful, avoidance of breast feeding for 2 days after lindane application.Lindane, topicalAntiscabetics

Excretion in milk is unknown, tumorigenic potential in some animal studiesPermethrin, topical

Page 29: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 29

Antituberculous agent

Adverse effectsDrugsGroups

Theoretical risk of convulsions and neuropathy. Prophylactic pyridoxine should be given to mother and babyIsoniazidAntituberculous agent  

Contraceptives

Adverse effectsDrugsGroups

AVOID combined oral contraceptives until weaning or for 6 months after birth. Progestogen-onlyOral ContraceptivesContraceptives

oral contraceptive do not appear to affect established milk flow adversely but may alter composition.

Cytotoxic Drugs

Adverse effectsDrugsGroups

AVOID - probably some risk of toxicity with most cytotoxicsAllCytotoxic Drugs

Page 30: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 31

Hormones 

Adverse effectsDrugsGroups

AVOID - may cause masculinisation in the female infant or precocious development in the male infant,Androgens

high doses suppress lactation

Should not be applied to the breasts prior to nursing.Corticosteroids, topHormones 

Prolonged, continuous treatment with high doses (> lOmg prednisolone daily) could affect infant 's adrenal functionCorticosteroids

Significant amounts in milk. Possible risk of anti-androgen effects on the infantCyproterone acetate

AVOID adverse effects on lactationOestrogens

Immunosuppressants

Adverse effectsDrugsGroups

AVOID - excreted into breast milk and potentially toxicCyclosporin Immunosuppressants

Page 31: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 31

Vitamins & Minerals

Adverse effectsDrugsGroups

Theoretical risk of toxicity in infants of mothers taking large dosesVitamin A

Severely thiamine-deficient mothers should not breastfeed as toxic methylglyoxal excreted in milkVitamin Bi (Thiamine)

Very large doses have been reported to have a lactationinhibiting effect. Monitor infant growthVitamin B6 ( Pyridoxine)Vitamins & minerals

Chronic maternal ingestion of large doses may result in hypercalcaemia in infantVitamin D

Miscellaneous

Adverse effectsDrugsGroups

AVOIDAcitretin/Etretinate

Isotretinoin

Caution because of cytotoxicityColchicine

Haemolytic anaemia; although significant amount in milk, risk to infant is very smallDapsone Miscellaneous

AVOID - risk of toxicity in infantHydroxychloroquine

AVOID - concentrated in breast milk, may cause thyroid suppression, goitreIodides

AVOID - potential for production of benign mammary fibroadenomas in animal studiesPentoxifylline

Excretion in human milk is unknown. Manufacturer recommends discontinuation of the drug or of nursingPodophyllum, (top)

Sufficient iodine can be absorbed from vaginal preparations to affect infant's thyroidPovidone iodine

Possible risk of haemolyticSulphasalazine

Page 32: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 32

References:

1. Physician's desk reference. Montvale, NJ: Thomson Healthcare;2005

2. BriggsGG,Freeman RK,Yaffe SL.Drugs in pregnancy and lactation, 7th ed. Baltimore,

MD: Lippincott William AND Wilkins;2005

3. FDA Consumer magazine Volume 35, Number 3 May-June 2001

4. Use of Dermatological Drugs in Pregnancy and Lactation. J Turkish German Gynecol

Assoc. 2004; 5(3): 203-207

5. Collaborative Group on Drug Use in Pregnancy. Medication during pregnancy: an

intercontinental cooperative study. Int J Gynaecol Obstet 39(3):185-96 (1992Nov).

6. Koren G, Pastuszak A, Ito S. Drugs in pregnancy. NEngl J Med 338(16):1128-37(1998

Apr).

7. Navarre-Belhassen C, Blanchet P, Hillaire-Buys D,Sarda P, Blayac JP. Multiple

congenital malformations associated with topical tretinoin. Ann Pharmacother32 (4):505-6

(1998 Apr).

8. Colley SM, Walpole I, Fabian VA, Kakulas BA. Topical tretinoin and fetal

malformations. Med J Aust 168(9):467 (1998 May).

9. Kallen BA, Otterblad Olausson P, Danielsson BR. Is erythromycin therapy teratogenic in

humans? Reprod Toxicol 20(2):209-14 (2005 Jul Aug).

10. Drug safety in lactation Website: May 2001 Prescriber Update No.21:10-23 Last accessed:

17/03/04 http://www.medsafe.govt.nz/Profs/PUarticles/lactation.htm

Page 33: Drugs in lactation and pregnancy

By : Dr. Mohammad Baghaei ,Cosmetic scientist, Pharmacist ,Facedoux 33

FACEDOUX DERMOCOSMETICS

Ultimate innovation for your skin