Upload
puskesmasmedandenai
View
215
Download
0
Embed Size (px)
Citation preview
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
1/11
RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013 21
Review Artcle
www.rjps.in
Safe Drugs During Pregnancyand Lactation
S.B. Puranik1, Imran Khan*1, Mohit Joshi2 and Mahvash Iram3
1Biocon Limited Bangalore, 2Srinivas College of Pharmacy Mangalore, 3Al-Ameen College of Pharmacy,
Hosur road Bangalore, Karnataka, India-560027
Received Date : 11-12-2012
Revised Date : 15-02-2013
Accepted Date : 28-02-2013
DOI: 10.5530/rjps.2013.1.4
Address for
correspondence
Mr. Imran Ahmad Khan
Biocon India Ltd,
20th KM, Hosur Road,
Electronic City,
Bangalore- 560100,
Karnataka (India)
Tel. 011-91- 9900434646E-mail:
ABSTRACT
Pregnancy is the carrying of one or more offspring, known as a fetus or embryo, inside the womb of a female.
Lactation describes the secretion of milk from the mammary glands, the process of providing milk to the young,
and the period of time that a mother lactates to feed her young one. This process occurs in all female mammals, in
humans it is commonly referred to as breastfeeding or nursing. This paper summarizes the factors determining fetal
damage and lists the problems associated with some drugs frequently encountered during Pregnancy and Lactation.
Keywords: Pregnancy, lactation, safe drugs, fetal damage.
INTRODUCTION
Pregnancy is the carrying of one or moreoffspring, known as a fetus or embryo, insidethe womb of a female. Lactation describesthe secretion of milk from the mammaryglands, the process of providing milk to the
young, and the period of time that a motherlactates to feed her young one. This processoccurs in all female mammals, in humans itis commonly referred to as breastfeeding ornursing. Medical scientists divide 40 weeksof pregnancy into 3 trimesters. The rst tri-mester is for weeks 012; the second is for1328 weeks, and the third for weeks 2940.1The hazards of exposing the human fetus todrugs have become increasingly apparent inthe last 15 years, during the time when drugusage has steadily increased. Even though a
direct cause-and-effect relationship betweencertain commonly used drugs and fetal dis-orders or malformations has been difcult
to establish, the principle of avoidance ofall but essential medications in pregnancyand in the potentially pregnant has becomeincreasingly important. This paper summa-rizes the factors determining fetal damageand lists the problems associated with somedrugs frequently encountered in practice.2
Drugs that a pregnant woman takes canaffect the fetus in several ways. They canact directly on the fetus causing damageor abnormal development leading to birthdefects or death. Drugs can also alter thefunction of the placenta usually by constrict-
ing blood vessels and reducing the blood sup-ply of oxygen and nutrients to the fetus frommother and thus resulting in a baby that isunderweight and underdeveloped. Moreoverthey can cause the muscles of the uterus tocontract forcefully; indirectly injuring thefetus by reducing the blood supply or trig-gering pre-term labor and delivery.3 Womenoverestimate the risk of drug use and otherexposures during pregnancy. Perception ofrisk may impact a womans decision to takea needed drug during pregnancy manifesting
various other complications. There is a pau-city of research on this topic in the literature.Therefore, it is important for health careproviders to use evidence-based informa-tion, to reduce unnecessary anxiety, and toensure safe and appropriate treatment duringpregnancy.4 This article is a summary regard-ing fetal and neonatal risk of prescriptiondrugs, over-the counter medications, vita-mins and vaccines.5 Survey has conrmed
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
2/11
S.B. Puranik. et al.: Pregnancy and Lactation......
22 RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013
that at present, some drugs are often more widely usedin pregnancy than is justied by the knowledge available.6
Database available for the information
A Motherisk symposium on establishing benchmarksfor the evaluation of medications during pregnancywas held on May 10, 2006, under the auspices of the
Canadian Society of Pharmacology and Therapeutics.From that symposium came a consensus on the needfor collection and analysis of data on fetal safety andongoing post-marketing surveillance, which in turnled to the establishment of Case Med-Pregnancy-theCanadian Alliance for Safe and Effective Medicationduring Pregnancy and Breastfeeding.7
Safefetus.com is a complete database of worldwidemedications (generic & trade) providing information onthe drugs indications, fetal risk, breastfeeding risk, dur-ing pregnancy, according to the FDA.8
The latest edition is the resource for any practicing Obste-
trician/Gynecologist, family physician, midwife, or phar-macist who prescribes medicinal products to or evaluatesenvironmental or occupational exposures in women whoare or may become pregnant. Based on the highly success-ful German editions of this reference, the up-to-date druglistings have been revised into a handy pocket guide colortabbed for quick access to important information.9 Anti-biotics were the most dispensed prescribed drug duringpregnancy, and the proportion of women lling prescrip-tions with antibiotics increased further during the lactatingperiod reaching almost 14%. The most prescribed antibi-otic drugs were -lactam and penicillins. Similar ndings
were reported in a Norwegian10 and a German11 study.12
Fifth edition of Drugs in Pregnancy and Lactation,
by Briggs GG, Freeman RK, Yaffee SJ is the source whichcontains information on drug effects during both preg-nancy and lactation. The monographs are comprehensiveand up to date and include information from sources thatare difcult for practicing physicians to locate.13
The need for further information on drug utilization pat-terns during pregnancy in different countries was assessedby reviewing literature. The resulting prole, from 13 identi-ed studies, was that, pregnant women used an average of
4.7 drugs. The most commonly ingested medications werevitamins and iron preparations (almost all women), analge-sics, antiemetics and antacids. However, important variables(such as date of surveillance; country; size of involved pop-ulation; habits; physiopathological and demographic char-acteristics), differently taken into account in each selectedstudy, made it impossible to construct a comprehensive,detailed, up-to-date picture about drug utilization duringpregnancy. The evaluation conrmed the need for and value
of systematic permanent surveillance of drug utilization inpregnancy, so as to avoid the use of data obtained in widely
differing contexts, times, and methods, in a eld where
knowledge is often based on scanty information.14 Thisanalysis of a large nation-wide cohort of pregnant womenshowed that during pregnancy drugs were prescribed tomost women, even when vitamins, minerals, iodide and ironwere omitted. Magnesium and iron seemed to have beenover-prescribed. On the other hand, the ofcial recommen-
dation for iodide substitution, to prevent thyroid diseases inmother and child, was insufciently implemented. In ouropinion, regular analysis of prescription data can identifypotential harmful therapies and focal points where guide-lines are needed and can check their implementation.15
How drugs act on fetus
Medications should be avoided by all women who areor might become pregnant. While some medications areknown to be harmful when taken during pregnancy, thesafety of most medications taken by pregnant womenhas been difcult to determine. The effects depend on
many factors, viz. How much medication was taken,when during the pregnancy the medication was taken,other health conditions a woman might have and othermedications a woman takes.16
Some of the fetuss blood vessels are contained in tinyhair like projections (villi) of the placenta that extendinto the wall of the uterus. The mothers blood passesthrough the space surrounding the villi (intervillousspace). Only a thin membrane (placental membrane)separates the mothers blood in the intervillous spacefrom the fetuss blood in the villi. Drugs in the mothersblood can cross this membrane into blood vessels in the
villi and pass through the umbilical cord to the fetus. Theprocess of drug transfer is shown in Figure 1.17
Most drugs that go into the body will also go into the milk,so before any medication is taken, consideration of its effecton baby and whether or not it has any effects on lactationneeds to be done. While most medications are safe to takewhile breastfeeding, its wise to talk to the doctor before tak-ing. Some drugs do not harm the baby, but may affect themilk volume by suppressing the milk-making hormones.On the other hand, some conditions (i.e., hypothyroidism)
Figure 1: Drug transfer to Fetus through Umbilical cord.
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
3/11
S.B. Puranik. et al.: Pregnancy and Lactation......
RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013 23
can interfere with ability to make milk, and medications totreat the problem will improve milk production. There arethree issues to consider when considering taking medica-tion while breastfeeding viz. is the drug needed, will thedrug affect baby, will the drug affect ability to make milk.18
More than 90% of pregnant women take prescrip-tion or nonprescription (over-the-counter) drugs or
use social drugs (such as tobacco and alcohol) or illicitdrugs at some time during pregnancy. In general, drugs,
unless absolutely necessary, should not be used dur-ing pregnancy because many can harm the fetus. About2 to 3% of all birth defects result from the use of drugsother than alcohol. Drugs that a pregnant woman takesduring pregnancy can affect the fetus in several ways, viz.they can act directly on the fetus, causing damage, abnormaldevelopment (leading to birth defects), or death, they canalter the function of the placenta, usually by causing blood
vessels to constrict and thus reducing the supply of oxy-gen and nutrients to the fetus from the mother. Sometimesthe result is a baby that is underweight and underdevel-oped, they can cause the muscles of the uterus to contractforcefully, indirectly injuring the fetus by reducing its bloodsupply or triggering preterm labor and delivery. Concernabout the safety of foreign compounds administered to
pregnant women has been increasingly evident since tha-lidomide. The direct response to this misadventure led tothe promulgation of the drug regulations of 1962 in theUnited States. According to these regulations, a drug mustbe demonstrated to be safe and effective for the conditionsof use prescribed in its labeling, including dosage level andpatient populations for whom the drug is intended.19
Over the years, far too many women have been wronglytold they had to stop breastfeeding. The decision aboutcontinuing breastfeeding when the mother takes a drug,
Table 1: List of Safe Drugs during Pregnancy and Lactation20
Sl. No. Name of the Drug Category
1. Acetaminophen Used for pain relief
2. Acyclovir and valacyclovir Antiviral for herpes infections
3. Antacids Used to treat upset stomachs
4. Bupivacaine A local anesthetic
5. Caffeine A stimulant
6. Clotrimazole Used to treat yeast and fungal infections
7. Cephalosporins Antibiotics for lung, ear, skin, urinary tract, throat, and bone infections
8. Contraceptives (progestin-only) Used for birth control
9. Corticosteroids Used to treat inammation of joints and other conditions
10. Decongestant nasal sprays Used to treat stuffy noses
11. Digoxin Used to treat heart problems
12. Erythromycin Used for skin and respiratory infections
13. Fexofenadine Antihistamine for allergies and hay fever
14. Fluconazole Used to treat yeast infections
15. Hepar in and Low molecular weight hepar ins
(enoxaparin, dalteparin, tinzaparin)
Used to prevent blood from clotting
16. Ibuprofen Used for pain relief
17. Inhalers, bronchodilators, and corticosteroids Used for asthma
18. Insulin For diabetes; dosage required may drop up to 25 percent during lactation
19. Laxatives, bulk-forming and stool softening Used to treat constipation
20. Lidocaine A local anesthetic
21. Loratadine Antihistamine for allergies and hay fever
22. Magnesium sulfate Used to treat preeclampsia and eclampsia
23. Methyldopa Used to treat high blood pressure
24. Methylergonovine (short courses) Used to prevent or control bleeding after childbirth
25. Metoprolol A beta-blocker used to treat high blood pressure26. Miconazole Used to treat yeast infections
27. Nifedipine Used for high blood pressure and Reynauds syndrome of the nipple
28. Penicillins Used to treat bacterial infections
29. Propranolol A beta blocker used to treat heart problems, and high blood pressure
30. Theophylline Used to treat asthma and bronchitis
31. Tretinoin Cream used for acne
32. Elotroxin Used to treat thyroid problems
33. Vaccines (except smallpox and yellow fever)
34. Vancomycin An antibiotic
35. Verapamil Used for high blood pressure
36. Warfarin Used to treat or prevent blood clots
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
4/11
S.B. Puranik. et al.: Pregnancy and Lactation......
24 RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013
Table 2: List of Probably Safe Drugs in Usual Doses20
Sl. No. Name of the Drug Category
1. ACE inhibitors Used to treat high blood pressure
2. Anticholinergic agents Used to treat intestinal and gall bladder spasms; may reduce milk supply
3. Anticonvulsants Used for seizures and mood disorders
4. Antihistamines May reduce milk supply and cause infant drowsiness or fussiness
5. Antituberculars Used to treat tuberculosis
6. Azathioprine Used to suppress the immune system following organ transplants
7. Barbiturates (except Phenobarbital) For sedation and tension headaches
8. Bupropion For depression
9. Clindamycin Used to treat abdominal and vaginal infections
10. Oral decongestants Used to treat congestion associated with colds or allergies; often reduces milk supply
11. Ergonovine (short course) Used to treat uterine bleeding. May reduce milk supply.
12. Fluconazole Antifungal
13. Gadolinium Contrast agent for MRI studies
14. Haloperidol Used to treat psychosis
15. Histamine H2
blockers Used to treat stomach problems
16. Labetalol Used for high blood pressure; caution with preterm babies
17. Hydrochlorothiazide (low doses) Diuretic for high blood pressure
18. Lorazepam Used to treat anxiety
19. Methimazole Used for hyperthyroidism; less than 20 mg/day is probably safe
20. Metoclopramide Used for gastrointestinal problems and to increase milk supply
21. Midazolam Sedative used in anesthesia
22. Naproxen Used for pain relief; okay if baby is at least 1 month old
23. Oxazepam Used to treat anxiety
24. Paroxetine Used to treat depression
25. Phenothiazines antipsychotic and antihistaminic
26. Propofol Sedative used in anesthesia
27. Propylthiouracil (PTU) Used to treat hyperthyroidism
28. Quinidine Used to treat heartbeat irregularities
29. Quinolone antibacterials Treatment of urinary tract infections
30. Salicylates (occasional use) Used for pain relief
31. Sertraline Used to treat depression
32. Spironolactone Used to treat high blood pressure
33. Sumatriptan Used to treat migraines
34. Tetracyclines < 14 days Used to treat acne and urinary tract infections
35. Trazodone Used for depression and sleep
36. Tricyclic antidepressants (avoid doxepin) Used to treat depression; nortriptyline preferred
37. Verapamil Used for high blood pressure
Table 3: List of Potentially Hazardous Drugs in Usual Doses20
Sl. No. Name of the Drug Category
1. Acebutolol A beta blocker used to treat high blood pressure and abnormal heart rhythms.
2. Atenolol A beta blocker used to treat high blood pressure and abnormal heart rhythms.
3. Antihistamine/decongestant combinations Used to treat colds and allergies; may reduce milk supply
4. Benzodiazepines Used to treat anxiety and for sleep (lorazepam, oxazepam preferred)
5. Chlorthalidone Diuretic used to treat high blood pressure; may reduce milk supply
6. Citalopram Antidepressant; can cause infant drowsiness
7. Clonidine Used to treat high blood pressure, may reduce milk supply
8. Contraceptives (estrogen-containing) Used for birth control; may reduce milk supply
9. Doxepin Used to treat depression
10. Ergotamine Used to treat migraines
11. Ethosuximide Used to treat epilepsy
12. Fluorescein IV Used to diagnose retinal problems
13. Fluoxetine Used to treat depression
14. Iodinated contrast media Used to examine kidneys; withhold breastfeeding temporarily
15. Lamotrigine Used for seizures and mood disorders
(Continued)
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
5/11
S.B. Puranik. et al.: Pregnancy and Lactation......
RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013 25
Table 3: (Continued)
Sl. No. Name of the Drug Category
16. Lithium (monitor infant serum levels) Used to treat bipolar disease
17. Metronidazole An antibiotic used to treat some intestinal and genital infections
18. Nadolol A beta blocker used to treat high blood pressure and heart problems
19. Narcotics, especially meperidine in addicts and
high doses with newborns
Used for pain (one tablet every six hours maximum; watch for drowsiness)
20. Nefazodone Used for depression
21. Nicotine Smoking can reduce milk supply
22. Nitrofurantoin Used to treat urinary tract infections (safe if the baby is at least 1 month old)
23. Phenobarbital, anticonvulsant doses Sedative and anticonvulsant
24. Piroxicam Used to treat arthritis and pain
25. Primidone Used to treat seizures
26. Reserpine Used to treat hypertension
27. Sotalol Used to treat heart problems
28. Thiazide diuretics, long-acting or high doses For high blood pressure or edema; high dose may reduce milk supply
29. Venlafaxine Used to treat depression
Table 4: List of Drugs not Safe to take in Usual Doses in Pregnancy and Lactation20
Sl. No. Name of the Drug Category
1. Amantadine Used to treat the u or Parkinsons disease2. Amiodarone Used to treat heart problems
3. Antilipemics (excluding resins) Used to lower the level of cholesterol in the blood
4. Antineoplastic agents Used to treat cancer
5. Aspirin (large doses) Used to treat arthritis
6. Cocaine Narcotic Analgesic
7. Chlorampenicol Used to treat serious infections
8. Clozapine Used to treat schizophrenia
9. Dipyrone (dipironain Mexican drugs) Used for pain and inammation
10. Gold Salts Used to treat arthritis
11. Iodide products Used for douching or as an expectorant
12. Iodine, radioactive Used to diagnose and treat hyperthyroidism
13. Lipid-lowering drugs Used to lower the level of fats in the blood
14. Metamizole (Dipyrone) Analgesic/anti-inammatory
15. Salicyclates, large doses Used to treat arthritis
Table 5: Problems Associated with Commonly Used Drugs
Sl. No. Category Examples Problem
1. Anti- anxiety drug Diazepam When the drug is taken late in pregnancy, depression,
irritability, shaking, and exaggerated reexes in the
newborn
2. Antibiotics Chloramphenicol Gray baby syndrome
In women or fetuses with glucose-6-phosphate
dehydrogenase (G6PD) deciency, the breakdown of red
blood cells
Fluoroquinolones (such as ciprooxacin,
ooxacin, levooxacin, and noroxacin)
Possibility of joint abnormalities (seen only in animals)
Kanamycin Damage to the fetuss ear, resulting in deafness(ototoxicity)
Nitrofurantoin In women or fetuses with G6PD deciency, the breakdown
of red blood cells
Streptomycin Damage to the fetuss ear, resulting in deafness(ototoxicity)
Sulfonamides (such assulfasalazine and
trimethoprim-sulfamethoxazole )
When the drugs are given late in pregnancy, jaundice and
possibly brain damage in the newborn (much less likely
with sulfasalazine)
In women or fetuses with G6PD deciency, the breakdown
of red blood cells
Tetracycline Slowed bone growth, permanent yellowing of the teeth,
and increased susceptibility to cavities in the baby
Occasionally, liver failure in the pregnant woman
(Continued)
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
6/11
S.B. Puranik. et al.: Pregnancy and Lactation......
26 RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013
Table 5: (Continued)
Sl. No. Category Examples Problem
3. Anticoagulants Heparin When the drug is taken for a long time, osteoporosis and a
decrease in the number of platelets in the pregnant woman
Warfarin Birth defects
Bleeding problems in the fetus and the pregnant woman
4. Anticonvulsants Carbamazepine Some risk of birth defects
Bleeding problems in the newborn, which can be prevented
if pregnant women take vitamin K orally every day fora month before delivery or if the newborn is given an
injection of vitamin K soon after birth
Phenytoin & Phenobarbital Same as those for carbamazepine
Trimethadione Increased risk of miscarriage in the woman
High (70%) risk of birth defects, including a cleft palate and
defects of the heart, face, skull, hands, or abdominal organs
Valproate Some (1%) risk of birth defects, including a cleft palate and
defects of the heart, face, skull, spine, or limbs
Angiotensin-converting enzyme (ACE)
inhibitors
When the drugs are taken late in pregnancy, kidney
damage in the fetus, a reduction in the amount of uid
around the developing fetus (amniotic uid), and defects of
the face, limbs, and lungs
5. Antihypertensive Beta-blockers When some beta-blockers are taken during pregnancy, a
slowed heart rate and low blood sugar level in the fetusand possibly slowed growth
Thiazide diuretics A decrease in the levels of oxygen, sodium, and potassium
and in the number of platelets in the fetuss blood
Slowed growth
Actinomycin Possibility of birth defects (seen only in animals)
6. Chemotherapy
drugs
Busulfan Birth defects such as underdevelopment of the lower jaw,
cleft palate, abnormal development of the skull bones,
spinal defects, ear defects, and clubfoot
Slowed growth
Chlorambucil, Cyclophosphamide,
Mercaptopurine & Methotrexate
Same as those with busulfun
Vincristine & Vinblastine Possibility of birth defects (seen only in animals)
7. Mood-stabilizing
drug
Lithium Birth defects (mainly of the heart), lethargy, reduced muscle
tone, poor feeding, underactivity of the thyroid gland, and
nephrogenic diabetes insipidus in the newborn
8. Non-steroidal
anti-inammatory
drugs (NSAIDs)
Aspirin and other salicylates
Ibuprofen, Naproxen
When the drugs are taken in large doses, a delay in the
start of labor, premature closing of the connection between
the aorta and artery to the lungs (ductus arteriosus),
jaundice, and (occasionally) brain damage in the fetus and
bleeding problems in the woman during and after delivery
and in the newborn
When the drugs are taken late in pregnancy, a reduction in
the amount of uid around the developing fetus
9. Oral anti-
hyperglycemic
drugs
Chlorpropamide & Tolbutamide A very low level of sugar in the blood of the newborn
Inadequate control of diabetes in the pregnant woman
When the drug is taken early in pregnancy by a woman with
type 2 diabetes, possibility of increased risk of birth defects
10. Sex hormones Danazol & Synthetic progestin (but not thelow doses used in oral contraceptives)
When this drug is taken very early in pregnancy,masculinization of a female fetuss genitals, sometimes
requiring surgery to correct
Diethylstilbestrol (DES) Abnormalities of the uterus, menstrual problems, and an
increased risk of vaginal cancer and complications during
pregnancy in daughters
Abnormalities of the penis in sons
11. Skin treatments Etretinate Birth defects, such as heart defects, small ears, and
hydrocephalus (sometimes called water on the brain)
Isotretinoin Same as those for etretinate
Mental retardation
Risk of miscarriage
(Continued)
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
7/11
S.B. Puranik. et al.: Pregnancy and Lactation......
RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013 27
Table 5: (Continued)
Sl. No. Category Examples Problem
12. Thyroid drugs Methimazole An enlarged or underactive thyroid gland in the fetus
Scalp defects in the newborn
Propylthiouracil An enlarged or underactive thyroid gland in the fetus
Radioactive iodine Destruction of the thyroid gland in the fetus
When the drug is given near the end of the 1st trimester,
very overactive and enlarged thyroid gland in the fetus
Triiodothyronine An overactive and enlarged thyroid gland in the fetus13. Vaccines (live
virus)
Vaccine for German measles (rubella) and
chickenpox (varicella)
Potential infection of the placenta and developing fetus
Vaccines for measles, mumps, polio, or
yellow fever
Potential but unknown risks
Table 6: Drugs Category Based on AAP22
Lactation Risk Categories Pregnancy Risk Categories
L1 (safest)
L2 (safer)
L3 (moderately safe)
L4 (possibly hazardous)
L5 (contraindicated)
A (controlled studies show no risk)
B (no evidence of risk in humans)
C (risk cannot be ruled out)
D (positive evidence of risk)
X (contraindicated in pregnancy)
for example, is far more involved than whether the babywill get any in the milk. It also involves taking into con-sideration the risks of not breastfeeding, for the mother,the baby and the family, as well as society. On the otherhand, it should be taken into consideration that somebabies may refuse to take the bottle completely, so thatthe advice to stop is not only wrong, but often impracti-
cal as well. On top of that it is easy to advise the motherto pump her milk while the baby is not breastfeeding,but this is not always easy in practice and the mothermay end up painfully engorged. So it is necessary toknow which drugs are safe for consumption duringpregnancy and lactation or the alternatives for that drug.
Medications are grouped into 1 of 5 categories based onthe potential for producing birth defects. The categories
are A, B, C, D and X. Generally speaking, drugs that fallinto either class A or B are considered safe and are routinelyused. There may be exceptions.21 The American Academyof Pediatrics has given a selected list of some approveddrugs by them for the use in breastfeeding mothers (AAPlist revised 8/04). This list is for general information only.They have classied these drugs in following categories.22
Table 7: List of Commonly Used Drugs during Pregnancy & Lactation Based on Risk Category22
Generic Name Pregnancy Risk Category Lactation Risk Category
Analgesics
Acetaminophen B L1Colchicine D L4
Nefopam NR
Non-Steroidal Anti-Infammatory Drugs (NSAIDs)
Azapropazone (apazone) L2
Dipyrone (banned in the US & UK) NR
Flufenamic acid NR
Ibuprofen B (1st, 2nd trim.) D (3rd trim.) L1
Indomethacin B (1st, 2nd trim.) D (3rd trim.) L3
Ketorolac B (1st, 2nd trim.) D (3rd trim.) L2
Mefenamic acid NR
Naproxen B L3, L4 (for chronic use)
Phenylbutazone NR
Piroxicam B L2
Suprofen NR
Tolmetin C L3
Narcotic Analgesic
Butorphanol B (1st, 2nd trim.), D (3rd trim.) L3
Codeine C L3
Fentanyl B L2
Meperidine BL2
L3 (if used early postpartum)
Methadone & Morphine B L3
Propoxyphene C L2
(Continued)
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
8/11
S.B. Puranik. et al.: Pregnancy and Lactation......
28 RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013
Anesthetics
Halothane & Lidocaine C L2
Methohexital B L3
Thiopental C L3
Antacids and gastrointestinal drugs
Cimetidine (Antacid) B L2Cisapride (GI tract stimulant) C L2
Domperidone (used for nausea & vomiting, stimulates
lactation) L1
Antibiotic
Amoxicillin B L1
Aztreonam B L2
Cefadroxil, Cefazolin, Cefoxitin & Ceftazidime B L1
Cefotaxime B L2
Cefprozil C L1
Ceftriaxone B L2
Ciprooxacin C L3
Clindamycin B L3
Erythromycin B L1, L3 early postnatal
Gentamicin & Ooxacin C L2
Kanamycin D L2
Fleroxacin, Moxalactam & Sulbactam NR
Nitrofurantoin B L2
Penicillin B L1
Streptomycin D L3
Carbamazepine & Sulsoxazole C L2
Tetracycline D L2
Ticarcillin B L1
Trimethoprim/sulfamethoxazole C L3
Anticoagulant
Bishydroxycoumarin (dicumarol) NR
Warfarin D L2
Anticonvulsant
Ethosuximide C L4
Magnesium sulfate B L1
Phenytoin & Valproic acid D L2
Antifungal
Fluconazole & Ketoconazole C L2
Antihistamine
Dexbrompheniramine maleate with d-isoephedrine NR
Fexofenadine C L2
Loratadine B L1
Terfenadine NR
Triprolidine C L1
AntiviralAcyclovir C L2
Interferon-alpha C L2
Arthritis Medication
Gold salts C L5
Asthma Medication
Dyphylline & Theophylline C L3
Terbutaline B L2
Contraceptives/Hormones
Estradiol X L3 (may interfere with milk production)
Clogestone NR
(Continued)
Table 7: (Continued)
Generic Name Pregnancy Risk Category Lactation Risk Category
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
9/11
S.B. Puranik. et al.: Pregnancy and Lactation......
RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013 29
Contraceptive pill with estrogen/progesterone X L3 (may interfere with milk production)
Levonorgestrel & Norethynodrel X L2
Medroxyprogesterone D L1, L4 (if used rst 3 days postpartum)
Progesterone L3
Anti-Tussive
Codeine C L3
Noscapine NR
Decongestants
Pseudoephedrine C L3 (for acute use), L4 (for chronic use)
Diabetes Medication
Note: Insulin has not been reviewed by the AAP. Pregnancy risk category = B; Lactation r isk category = L1.
Tolbutamide D L3
Anti-Diarrheal
Loperamide B L2
Note: Pepto-Bismol & Kaopectate (bismuth subsalicylate is the active ingredient in both) are not recommended for routine use by
nursing mothers, due to the association of salicylates with Reyes syndrome in children.
Diuretics
Acetazolamide C L2
Bendroumethiazide D L4 (may inhibit lactation)Chlorothiazide & Chlorthalidone D L3
Hydrochlorothiazide & Spironolactone D L2
Galactagogues
Domperidone L1
Antiarrhythmic/Antihypertensive/Cardiac Stimulant
Antiarrhythmics
Disopyramide & Quinidine C L2
Flecainide & Procainamide C L3
Mexiletine B L2
Antihypertensive
Captopril D L3 (if used after 30 days)
Diltiazem/Diltiazem HCL C L3
Enalapril/Enalapril Maleate C (1st trim.), D (2nd, 3rd trim.) L2Hydralazine, Labetalol & Methyldopa C L2
Minoxidil C L2 (topically), L3 (orally)
Nadolol C L4
Nifedipine C L2
Oxprenolol NR
Propranolol, Timolol & Verapamil C L2
Sotalol B L3
Cardiac Stimulants
Digoxin C L2
Laxatives
Cascara/Cascara Sagrada C L3
Danthron NR
Magnesium sulfate B L1Senna L3
Anti-Malarial
Chloroquine C L3
Hydroxychloroquine C L2
Pyrimethamine C L4
Quinine D L2
Diagnostic agents
Diatrizoate NR
Fluorescein C L3
Gadopentetic (Gadolinium) C L2
(Continued)
Table 7: (Continued)
Generic Name Pregnancy Risk Category Lactation Risk Category
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
10/11
S.B. Puranik. et al.: Pregnancy and Lactation......
30 RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013
Iohexol, Metrizoate & Metrizamide B L2
Iopanoic acid D L2
Migraine Medication
Sumatriptan C L3
Sedatives
Chloral hydrate C L3
Methyprylon (withdrawn from use in US & Canada) NR
Bromide D L5
Secobarbital D L3
Sleep Aids
Zolpidem/Zolpidem Tartrate B L3
Steroids
Prednisone, Prednisolone & Methylprednisolone [high
dosage methylprednisolone]C L2
Thyroid
Carbimazole & active metabolite of carbimazole
(Methimazole)D L3
Propylthiouracil D L2
Thiouracil NR
Levothyroxine A L1
Tuberculosis
Cycloserine & Isoniazid C L3
Ethambutol B L2
Rifampin C L2
Vitamins
B-1 (thiamin) NR
B-12 (Cyanocobalamin) A L1
B-6 (pyridoxine) A L2; L4 in high doses (may inhibit lactation)
D, vitamin A L3 (do not overdose)
Folic acid A (1st, 2nd trim.), C (3rd trim.) L1
K-1, vitamin (Phytonadione) C L1
Riboavin/B2
A L1
Miscellaneous
Acitretin (Anti-psoriasis) NR
Alcohol/Ethanol D L3
Allopurinol C L2
Antimony NR
Atropine (Anticholinergic, drying agent) C L3
Azapropazone/apazone (Antirheumatic) L2
Baclofen (muscle relaxant) C L2
Barbiturate NR
Caffeine B L2
Carbetocin (Antihemorrhagic) NR
Chloroform NR
Cisplatin (Anti-cancer) D L4
Dapsone (Antileprosy) C L4
Hydroxychloroquine (Antirheumatic, lupus) C L2
Iodine & Iodides (povidone-iodine, e.g., in a vaginal
douche) NR
Ivermectin (Antiparasitic) C L3
Nalidixic acid (Urinary Anti-infective) B L4
Norsteroids NR
Pyridostigmine (Muscle stimulant) C L2
Scopolamine (Motion sickness) C L3
Sulfapyridine NR
Timolol (glaucoma med) D L3
*NR: Not Reviewed. This drug has not yet been reviewed by the AAP.
Table 7: (Continued)
Generic Name Pregnancy Risk Category Lactation Risk Category
7/29/2019 The List of Safe Drugs During Pregnancy & Lactation
11/11
S.B. Puranik. et al.: Pregnancy and Lactation......
RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013 31
CONCLUSION
Drugs should be avoided by all women who are ormight become pregnant. While some medications areknown to be harmful when taken during pregnancy, thesafety of most medications taken by pregnant womenhas been difcult to determine. The effects depend on
many factors, viz. How much medication was taken,
when during the pregnancy the medication was taken,other health conditions a woman might have and othermedications a woman takes?Some of the fetuss bloodvessels are contained in tiny hair like projections (villi)of the placenta that extend into the wall of the uterus.The mothers blood passes through the space surround-ing the villi (intervillous space). Only a thin membrane(placental membrane) separates the mothers bloodin the intervillous space from the fetuss blood in thevilli. Drugs in the mothers blood can cross this mem-brane into blood vessels in the villi and pass through theumbilical cord to the fetus. Most drugs that go into the
body will also go into the milk, so before any medicationis taken, consideration of its effect on baby and whetheror not it has any effects on lactation must be made.
REFERENCES
1. http://www.healthlit.org/documents/PregnancyBooklet.pdf 24.05.2011.
11:05pm.
2. Forrest JM. Drugs in pregnancy and lactation. Med J Aust 1976:
24;2(4):13841.
3. P. Sachdeva, B. G. Patel and B. K. Patel. Drug Use in Pregnancy; a
Point to Ponder. Indian J Pharm Sci 2009; 71(1): 17.
4. Nordeng H, Ystrm E, Einarson A. Perception of risk regarding the
use of medications and other exposures during pregnancy. Eur J Clin
Pharmacol 2010; 66(2):20714.
5. Gerald G. Briggs, Roger K. Freeman and Sumner J. Drugs in Pregnancy
and Lactation. CMAJ, 1987 VOL 136:507.
6. Medication during pregnancy: an intercontinental cooperative study.
Collaborative Group on Drug Use in Pregnancy (C.G.D.U.P.). Int J
Gynaecol Obstet 1992; 39(3):18596.
7. Davis DB. Drugs in pregnancy--the issues for 2010. J Popul Ther Clin
Pharmacol 2010; 17(3):3325.
8. http://www.safefetus.com/. 25.05.2011. 12:45pm.
9. Christof Schaefer, Paul Peters WJ, Richard KM. Drugs During
Pregnancy and Lactation Treatment Options and Risk Assessment.
Elsevier Science & Technology; second edition. Netherland.
10. Engeland A, Bramness JG, Daltveit AK, Rnning M, Skurtveit S, Furu K.
Prescription drug use among fathers and mothers before and during
pregnancy. Br J Clin Pharmacol 2008; 65(5):65360.
11. Amann U, Egen-Lappe V, Strunz-Lehner C, Hasford J. Antibiotics
in pregnancy: analysis of potential risks and determinants in a large
German statutory sickness fund population. Pharmacoepidemiol Drug
Saf 2006; 15(5):32737.
12. Olof Stephansson et al. Drug use during pregnancy in Sweden
assessed by the Prescribed Drug Register and the Medical Birth
Register. Clinical Epidemiology 2011: 3 4350.
13. Briggs GG, Freeman RK, Yaffee SJ. Drugs in Pregnancy and Lactation.
5th edition. Publisher Baltimore Williams & Wilkins; 1998.
14. Bonati M, Bortolus R, Marchetti F, Romero M, Tognoni G. Drug use in
pregnancy: an overview of epidemiological (drug utilization) studies.
Eur J Clin Pharmacol 1990; 38(4):3258.15. Egen-Lappe V, Hasford J. Drug prescription in pregnancy: analysis of
a large statutory sickness fund population. Eur J Clin Pharmacol 2004;
60(9):65966.
16. http://www.cdc.gov/ncbddd/pregnancy_gateway/meds/index.html.
25.05.2011. 05:45pm.
17. http://www.merckmanuals.com/home/sec22/ch259/ch259a.html.
25.05.2011. 06:25pm.
18. http://www.askdrsears.com/html/2/t028500.asp 26.05.2011. 11:10AM.
19. Gerald GB, Roger KF, Sumner JY. Drugs in pregnancy and lactation.
Eighth edition. Lipincott Williams and Wilkins. Philadelphia 2008.
20. http://www.babycenter.com/0_drug-safety-during-breastfeeding_8790.
bc.26.05.2011. 04:30.
21. http://www.globalrph.com/pregnancy.htm. 27.05.2011.
22. Hale, Thomas. Medications and Mothers Milk, 12th Edition. Hale
Publishing, 2006.