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Review Article

Safe Drugs During Pregnancy and Lactation


S.B. Puranik1, Imran Khan*1, Mohit Joshi2 and Mahvash Iram3
Biocon Limited Bangalore, 2Srinivas College of Pharmacy Mangalore, 3Al-Ameen College of Pharmacy, Hosur road Bangalore, Karnataka, India-560027
1

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 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. Medical scientists divide 40 weeks of pregnancy into 3 trimesters. The first trimester is for weeks 012; the second is for 1328 weeks, and the third for weeks 2940.1 The hazards of exposing the human fetus to drugs have become increasingly apparent in the last 15 years, during the time when drug usage has steadily increased. Even though a direct cause-and-effect relationship between certain commonly used drugs and fetal disorders or malformations has been difficult to establish, the principle of avoidance of all but essential medications in pregnancy and in the potentially pregnant has become increasingly important. This paper summarizes the factors determining fetal damage and lists the problems associated with some drugs frequently encountered in practice.2
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Drugs that a pregnant woman takes can affect the fetus in several ways. They can act directly on the fetus causing damage or abnormal development leading to birth defects or death. Drugs can also alter the function of the placenta usually by constricting blood vessels and reducing the blood supply of oxygen and nutrients to the fetus from mother and thus resulting in a baby that is underweight and underdeveloped. Moreover they can cause the muscles of the uterus to contract forcefully; indirectly injuring the fetus by reducing the blood supply or triggering pre-term labor and delivery.3 Women overestimate the risk of drug use and other exposures during pregnancy. Perception of risk may impact a womans decision to take a needed drug during pregnancy manifesting various other complications. There is a paucity of research on this topic in the literature. Therefore, it is important for health care providers to use evidence-based information, to reduce unnecessary anxiety, and to ensure safe and appropriate treatment during pregnancy.4 This article is a summary regarding fetal and neonatal risk of prescription drugs, over-the counter medications, vitamins and vaccines.5 Survey has confirmed

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- 9900434646 E-mail: mahvashiram@gmail.com

www.rjps.in

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S.B. Puranik. et al.: Pregnancy and Lactation......

that at present, some drugs are often more widely used in pregnancy than is justified by the knowledge available.6
Database available for the information

A Motherisk symposium on establishing benchmarks for the evaluation of medications during pregnancy was held on May 10, 2006, under the auspices of the Canadian Society of Pharmacology and Therapeutics. From that symposium came a consensus on the need for collection and analysis of data on fetal safety and ongoing post-marketing surveillance, which in turn led to the establishment of Case Med-Pregnancy-the Canadian Alliance for Safe and Effective Medication during Pregnancy and Breastfeeding.7 Safefetus.com is a complete database of worldwide medications (generic & trade) providing information on the drugs indications, fetal risk, breastfeeding risk, during pregnancy, according to the FDA.8 The latest edition is the resource for any practicing Obstetrician/Gynecologist, family physician, midwife, or pharmacist who prescribes medicinal products to or evaluates environmental or occupational exposures in women who are or may become pregnant. Based on the highly successful German editions of this reference, the up-to-date drug listings have been revised into a handy pocket guide color tabbed for quick access to important information.9 Antibiotics were the most dispensed prescribed drug during pregnancy, and the proportion of women filling prescriptions with antibiotics increased further during the lactating period reaching almost 14%. The most prescribed antibiotic drugs were -lactam and penicillins. Similar findings 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 which contains information on drug effects during both pregnancy and lactation. The monographs are comprehensive and up to date and include information from sources that are difficult for practicing physicians to locate.13 The need for further information on drug utilization patterns during pregnancy in different countries was assessed by reviewing literature. The resulting profile, from 13 identified studies, was that, pregnant women used an average of 4.7 drugs. The most commonly ingested medications were vitamins and iron preparations (almost all women), analgesics, antiemetics and antacids. However, important variables (such as date of surveillance; country; size of involved population; habits; physiopathological and demographic characteristics), differently taken into account in each selected study, made it impossible to construct a comprehensive, detailed, up-to-date picture about drug utilization during pregnancy. The evaluation confirmed the need for and value of systematic permanent surveillance of drug utilization in pregnancy, so as to avoid the use of data obtained in widely
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differing contexts, times, and methods, in a field where knowledge is often based on scanty information.14 This analysis of a large nation-wide cohort of pregnant women showed that during pregnancy drugs were prescribed to most women, even when vitamins, minerals, iodide and iron were omitted. Magnesium and iron seemed to have been over-prescribed. On the other hand, the official recommendation for iodide substitution, to prevent thyroid diseases in mother and child, was insufficiently implemented. In our opinion, regular analysis of prescription data can identify potential harmful therapies and focal points where guidelines are needed and can check their implementation.15
How drugs act on fetus

Medications should be avoided by all women who are or might become pregnant. While some medications are known to be harmful when taken during pregnancy, the safety of most medications taken by pregnant women has been difficult 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 other medications a woman takes.16 Some of the fetuss blood vessels 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 surrounding the villi (intervillous space). Only a thin membrane (placental membrane) separates the mothers blood in the intervillous space from the fetuss blood in the villi. Drugs in the mothers blood can cross this membrane into blood vessels in the villi and pass through the umbilical cord to the fetus. The process 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 effect on baby and whether or not it has any effects on lactation needs to be done. While most medications are safe to take while breastfeeding, its wise to talk to the doctor before taking. Some drugs do not harm the baby, but may affect the milk 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.


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can interfere with ability to make milk, and medications to treat the problem will improve milk production. There are three issues to consider when considering taking medication while breastfeeding viz. is the drug needed, will the drug affect baby, will the drug affect ability to make milk.18 More than 90% of pregnant women take prescription or nonprescription (over-the-counter) drugs or use social drugs (such as tobacco and alcohol) or illicit drugs at some time during pregnancy. In general, drugs, unless absolutely necessary, should not be used during pregnancy because many can harm the fetus. About 2 to 3% of all birth defects result from the use of drugs other than alcohol. Drugs that a pregnant woman takes during pregnancy can affect the fetus in several ways, viz. they can act directly on the fetus, causing damage, abnormal development (leading to birth defects), or death, they can alter the function of the placenta, usually by causing blood
Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. Name of the Drug Acetaminophen Acyclovir and valacyclovir Antacids Bupivacaine Caffeine Clotrimazole Cephalosporins Contraceptives (progestin-only) Corticosteroids Decongestant nasal sprays Digoxin Erythromycin Fexofenadine Fluconazole Heparin and Low molecular weight heparins (enoxaparin, dalteparin, tinzaparin) Ibuprofen Inhalers, bronchodilators, and corticosteroids Insulin Laxatives, bulk-forming and stool softening Lidocaine Loratadine Magnesium sulfate Methyldopa Methylergonovine (short courses) Metoprolol Miconazole Nifedipine Penicillins Propranolol Theophylline Tretinoin Elotroxin Vaccines (except smallpox and yellow fever) Vancomycin Verapamil Warfarin

vessels to constrict and thus reducing the supply of oxygen and nutrients to the fetus from the mother. Sometimes the result is a baby that is underweight and underdeveloped, they can cause the muscles of the uterus to contract forcefully, indirectly injuring the fetus by reducing its blood supply or triggering preterm labor and delivery. Concern about the safety of foreign compounds administered to pregnant women has been increasingly evident since thalidomide. The direct response to this misadventure led to the promulgation of the drug regulations of 1962 in the United States. According to these regulations, a drug must be demonstrated to be safe and effective for the conditions of use prescribed in its labeling, including dosage level and patient populations for whom the drug is intended.19 Over the years, far too many women have been wrongly told they had to stop breastfeeding. The decision about continuing breastfeeding when the mother takes a drug,

Table 1: List of Safe Drugs during Pregnancy and Lactation20


Category Used for pain relief Antiviral for herpes infections Used to treat upset stomachs A local anesthetic A stimulant Used to treat yeast and fungal infections Antibiotics for lung, ear, skin, urinary tract, throat, and bone infections Used for birth control Used to treat inflammation of joints and other conditions Used to treat stuffy noses Used to treat heart problems Used for skin and respiratory infections Antihistamine for allergies and hay fever Used to treat yeast infections Used to prevent blood from clotting Used for pain relief Used for asthma For diabetes; dosage required may drop up to 25 percent during lactation Used to treat constipation A local anesthetic Antihistamine for allergies and hay fever Used to treatpreeclampsiaand eclampsia Used to treat high blood pressure Used to prevent or control bleeding after childbirth A beta-blocker used to treat high blood pressure Used to treat yeast infections Used for high blood pressure and Reynauds syndrome of the nipple Used to treat bacterial infections A beta blocker used to treat heart problems, and high blood pressure Used to treat asthma and bronchitis Cream used for acne Used to treat thyroid problems An antibiotic Used for high blood pressure Used to treat or prevent blood clots
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Table 2: List of Probably Safe Drugs in Usual Doses20


Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. Name of the Drug ACE inhibitors Anticholinergic agents Anticonvulsants Antihistamines Antituberculars Azathioprine Barbiturates (except Phenobarbital) Bupropion Clindamycin Oral decongestants Ergonovine (short course) Fluconazole Gadolinium Haloperidol Histamine H2 blockers Labetalol Hydrochlorothiazide (low doses) Lorazepam Methimazole Metoclopramide Midazolam Naproxen Oxazepam Paroxetine Phenothiazines Propofol Propylthiouracil (PTU) Quinidine Quinolone antibacterials Salicylates (occasional use) Sertraline Spironolactone Sumatriptan Tetracyclines < 14 days Trazodone Tricyclic antidepressants (avoid doxepin) Verapamil Category Used to treat high blood pressure Used to treat intestinal and gall bladder spasms; may reduce milk supply Used for seizures and mood disorders May reduce milk supply and cause infant drowsiness or fussiness Used to treat tuberculosis Used to suppress the immune system following organ transplants For sedation and tension headaches For depression Used to treat abdominal and vaginal infections Used to treat congestion associated with colds or allergies; often reduces milk supply Used to treat uterine bleeding. May reduce milk supply. Antifungal Contrast agent for MRI studies Used to treat psychosis Used to treat stomach problems Used for high blood pressure; caution with preterm babies Diuretic for high blood pressure Used to treat anxiety Used for hyperthyroidism; less than 20 mg/day is probably safe Used for gastrointestinal problems and to increase milk supply Sedative used in anesthesia Used for pain relief; okay if baby is at least 1 month old Used to treat anxiety Used to treat depression antipsychotic and antihistaminic Sedative used in anesthesia Used to treat hyperthyroidism Used to treat heartbeat irregularities Treatment of urinary tract infections Used for pain relief Used to treat depression Used to treat high blood pressure Used to treat migraines Used to treat acne and urinary tract infections Used for depression and sleep Used to treat depression; nortriptyline preferred Used for high blood pressure

Table 3: List of Potentially Hazardous Drugs in Usual Doses20


Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
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Name of the Drug Acebutolol Atenolol Antihistamine/decongestant combinations Benzodiazepines Chlorthalidone Citalopram Clonidine Contraceptives (estrogen-containing) Doxepin Ergotamine Ethosuximide Fluorescein IV Fluoxetine Iodinated contrast media Lamotrigine

Category A beta blocker used to treat high blood pressure and abnormal heart rhythms. A beta blocker used to treat high blood pressure and abnormal heart rhythms. Used to treat colds and allergies; may reduce milk supply Used to treat anxiety and for sleep (lorazepam, oxazepam preferred) Diuretic used to treat high blood pressure; may reduce milk supply Antidepressant; can cause infant drowsiness Used to treat high blood pressure, may reduce milk supply Used for birth control; may reduce milk supply Used to treat depression Used to treat migraines Used to treat epilepsy Used to diagnose retinal problems Used to treat depression Used to examine kidneys; withhold breastfeeding temporarily Used for seizures and mood disorders (Continued)
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Table 3: (Continued)
Sl. No. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. Name of the Drug Lithium (monitor infant serum levels) Metronidazole Nadolol Narcotics, especially meperidine in addicts and high doses with newborns Nefazodone Nicotine Nitrofurantoin Phenobarbital, anticonvulsant doses Piroxicam Primidone Reserpine Sotalol Thiazide diuretics, long-acting or high doses Venlafaxine Category Used to treat bipolar disease An antibiotic used to treat some intestinal and genital infections A beta blocker used to treat high blood pressure and heart problems Used for pain (one tablet every six hours maximum; watch for drowsiness) Used for depression Smoking can reduce milk supply Used to treat urinary tract infections (safe if the baby is at least 1 month old) Sedative and anticonvulsant Used to treat arthritis and pain Used to treat seizures Used to treat hypertension Used to treat heart problems For high blood pressure or edema; high dose may reduce milk supply Used to treat depression

Table 4: List of Drugs not Safe to take in Usual Doses in Pregnancy and Lactation20
Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Name of the Drug Amantadine Amiodarone Antilipemics (excluding resins) Antineoplastic agents Aspirin (large doses) Cocaine Chlorampenicol Clozapine Dipyrone (dipironain Mexican drugs) Gold Salts Iodide products Iodine, radioactive Lipid-lowering drugs Metamizole (Dipyrone) Salicyclates, large doses Category Used to treat the flu or Parkinsons disease Used to treat heart problems Used to lower the level of cholesterol in the blood Used to treat cancer Used to treat arthritis Narcotic Analgesic Used to treat serious infections Used to treat schizophrenia Used for pain and inflammation Used to treat arthritis Used for douching or as an expectorant Used to diagnose and treat hyperthyroidism Used to lower the level of fats in the blood Analgesic/anti-inflammatory Used to treat arthritis

Table 5: Problems Associated with Commonly Used Drugs


Sl. No. 1. Category Anti- anxiety drug Examples Diazepam Problem When the drug is taken late in pregnancy, depression, irritability, shaking, and exaggerated reflexes in the newborn Gray baby syndrome In women or fetuses with glucose-6-phosphate dehydrogenase (G6PD) deficiency, the breakdown of red blood cells Possibility of joint abnormalities (seen only in animals) Damage to the fetuss ear, resulting in deafness(ototoxicity) In women or fetuses with G6PD deficiency, the breakdown of red blood cells Damage to the fetuss ear, resulting in deafness(ototoxicity) When the drugs are given late in pregnancy, jaundice and possibly brain damage in the newborn (much less likely withsulfasalazine) In women or fetuses with G6PD deficiency, the breakdown of red blood cells Slowed bone growth, permanent yellowing of the teeth, and increased susceptibility to cavities in the baby Occasionally, liver failure in the pregnant woman (Continued)
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2.

Antibiotics

Chloramphenicol

Fluoroquinolones (such asciprofloxacin, ofloxacin, levofloxacin, and norfloxacin) Kanamycin Nitrofurantoin Streptomycin Sulfonamides (such assulfasalazine and trimethoprim-sulfamethoxazole)

Tetracycline

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Table 5: (Continued)
Sl. No. 3. Category Anticoagulants Examples Heparin Warfarin 4. Anticonvulsants Carbamazepine Problem When the drug is taken for a long time, osteoporosis and a decrease in the number of platelets in the pregnant woman Birth defects Bleeding problems in the fetus and the pregnant woman Some risk of birth defects Bleeding problems in the newborn, which can be prevented if pregnant women take vitamin K orally every day for a month before delivery or if the newborn is given an injection of vitamin K soon after birth Same as those forcarbamazepine 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 Some (1%) risk of birth defects, including a cleft palate and defects of the heart, face, skull, spine, or limbs When the drugs are taken late in pregnancy, kidney damage in the fetus, a reduction in the amount of fluid around the developing fetus (amniotic fluid), and defects of the face, limbs, and lungs When some beta-blockers are taken during pregnancy, a slowed heart rate and low blood sugar level in the fetus and possibly slowed growth A decrease in the levels of oxygen, sodium, and potassium and in the number of platelets in the fetuss blood Slowed growth Possibility of birth defects (seen only in animals) 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 Same as those with busulfun Possibility of birth defects (seen only in animals) Birth defects (mainly of the heart), lethargy, reduced muscle tone, poor feeding, underactivity of the thyroid gland, and nephrogenic diabetes insipidus in the newborn 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 fluid around the developing fetus 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 When this drug is taken very early in pregnancy, masculinization of a female fetuss genitals, sometimes requiring surgery to correct 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 Birth defects, such as heart defects, small ears, and hydrocephalus (sometimes called water on the brain) Same as those for etretinate Mental retardation Risk of miscarriage (Continued)
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Phenytoin & Phenobarbital Trimethadione

Valproate Angiotensin-converting enzyme (ACE) inhibitors

5.

Antihypertensive

Beta-blockers

Thiazide diuretics

Actinomycin 6. Chemotherapy drugs Busulfan

Chlorambucil, Cyclophosphamide, Mercaptopurine & Methotrexate Vincristine & Vinblastine 7. Mood-stabilizing drug Non-steroidal anti-inflammatory drugs (NSAIDs) Lithium

8.

Aspirinand other salicylates Ibuprofen, Naproxen

9.

Oral antihyperglycemic drugs Sex hormones

Chlorpropamide& Tolbutamide

10.

Danazol & Synthetic progestin (but not the low doses used in oral contraceptives) Diethylstilbestrol (DES)

11.

Skin treatments

Etretinate Isotretinoin

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Table 5: (Continued)
Sl. No. 12. Category Thyroid drugs Examples Methimazole Propylthiouracil Radioactive iodine Problem An enlarged or underactive thyroid gland in the fetus Scalp defects in the newborn An enlarged or underactive thyroid gland in the fetus 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 An overactive and enlarged thyroid gland in the fetus Potential infection of the placenta and developing fetus Potential but unknown risks

13.

Vaccines (live virus)

Triiodothyronine Vaccine for German measles (rubella) and chickenpox (varicella) Vaccines for measles, mumps, polio, or yellow fever

for example, is far more involved than whether the baby will get any in the milk. It also involves taking into consideration the risks of not breastfeeding, for the mother, the baby and the family, as well as society. On the other hand, it should be taken into consideration that some babies may refuse to take the bottle completely, so that the advice to stop is not only wrong, but often impractical as well. On top of that it is easy to advise the mother to pump her milk while the baby is not breastfeeding, but this is not always easy in practice and the mother may end up painfully engorged. So it is necessary to know which drugs are safe for consumption during pregnancy and lactation or the alternatives for that drug. Medications are grouped into 1 of 5 categories based on the potential for producing birth defects. The categories
Generic Name Analgesics Acetaminophen Colchicine Nefopam Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Azapropazone (apazone) Dipyrone (banned in the US & UK) Flufenamic acid Ibuprofen Indomethacin Ketorolac Mefenamic acid Naproxen Phenylbutazone Piroxicam Suprofen Tolmetin Narcotic Analgesic Butorphanol Codeine Fentanyl Meperidine Methadone & Morphine Propoxyphene

are A, B, C, D and X. Generally speaking, drugs that fall into either class A or B are considered safe and are routinely used. There may be exceptions.21 The A merican Academy of Pediatrics has given a selected list of some approved drugs by them for the use in breastfeeding mothers (AAP list revised 8/04). This list is for general information only. They have classified these drugs in following categories.22
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)

Table 7: List of Commonly Used Drugs during Pregnancy & Lactation Based on Risk Category22
Pregnancy Risk Category B D B(1st, 2nd trim.) D(3rd trim.) B(1st, 2nd trim.) D(3rd trim.) B(1st, 2nd trim.) D(3rd trim.) B B C B(1st, 2nd trim.), D(3rd trim.) C B B B C Lactation Risk Category L1 L4 NR L2 NR NR L1 L3 L2 NR L3, L4(for chronic use) NR L2 NR L3 L3 L3 L2 L2 L3(if used early postpartum) L3 L2 (Continued)
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Table 7: (Continued)
Generic Name Anesthetics Halothane & Lidocaine Methohexital Thiopental Antacids and gastrointestinal drugs Cimetidine (Antacid) Cisapride (GI tract stimulant) Domperidone (used for nausea & vomiting, stimulates lactation) Antibiotic Amoxicillin Aztreonam Cefadroxil, Cefazolin, Cefoxitin & Ceftazidime Cefotaxime Cefprozil Ceftriaxone Ciprofloxacin Clindamycin Erythromycin Gentamicin & Ofloxacin Kanamycin Fleroxacin, Moxalactam & Sulbactam Nitrofurantoin Penicillin Streptomycin Carbamazepine & Sulfisoxazole Tetracycline Ticarcillin Trimethoprim/sulfamethoxazole Anticoagulant Bishydroxycoumarin (dicumarol) Warfarin Anticonvulsant Ethosuximide Magnesium sulfate Phenytoin & Valproic acid Antifungal Fluconazole & Ketoconazole Antihistamine Dexbrompheniramine maleate with d-isoephedrine Fexofenadine Loratadine Terfenadine Triprolidine Antiviral Acyclovir Interferon-alpha Arthritis Medication Gold salts Asthma Medication Dyphylline & Theophylline Terbutaline Contraceptives/Hormones Estradiol Clogestone Pregnancy Risk Category C B C B C B B B B C B C B B C D B B D C D B C D C B D C C B C C C C C B X Lactation Risk Category L2 L3 L3 L2 L2 L1 L1 L2 L1 L2 L1 L2 L3 L3 L1, L3early postnatal L2 L2 NR L2 L1 L3 L2 L2 L1 L3 NR L2 L4 L1 L2 L2 NR L2 L1 NR L1 L2 L2 L5 L3 L2 L3(may interfere with milk production) NR (Continued)
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Table 7: (Continued)
Generic Name Contraceptive pill with estrogen/progesterone Levonorgestrel & Norethynodrel Medroxyprogesterone Progesterone Anti-Tussive Codeine Noscapine Decongestants Pseudoephedrine Pregnancy Risk Category X X D C C Lactation Risk Category L3(may interfere with milk production) L2 L1, L4(if used first 3 days postpartum) L3 L3 NR L3(for acute use), L4(for chronic use)

Diabetes Medication Note: Insulin has not been reviewed by the AAP. Pregnancy risk category = B; Lactation risk 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 Bendroflumethiazide Chlorothiazide & Chlorthalidone Hydrochlorothiazide & Spironolactone Galactagogues Domperidone Antiarrhythmic/Antihypertensive/Cardiac Stimulant Antiarrhythmics Disopyramide & Quinidine Flecainide & Procainamide Mexiletine Antihypertensive Captopril Diltiazem/Diltiazem HCL Enalapril/Enalapril Maleate Hydralazine, Labetalol & Methyldopa Minoxidil Nadolol Nifedipine Oxprenolol Propranolol, Timolol & Verapamil Sotalol Cardiac Stimulants Digoxin Laxatives Cascara/Cascara Sagrada Danthron Magnesium sulfate Senna Anti-Malarial Chloroquine Hydroxychloroquine Pyrimethamine Quinine Diagnostic agents Diatrizoate Fluorescein Gadopentetic (Gadolinium) C D D D L2 L4(may inhibit lactation) L3 L2 L1

C C B D C C(1st trim.), D(2nd, 3rd trim.) C C C C C B C C B C C C D C C

L2 L3 L2 L3(if used after 30 days) L3 L2 L2 L2(topically), L3(orally) L4 L2 NR L2 L3 L2 L3 NR L1 L3 L3 L2 L4 L2 NR L3 L2 (Continued)

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Table 7: (Continued)
Generic Name Iohexol, Metrizoate & Metrizamide Iopanoic acid Migraine Medication Sumatriptan Sedatives Chloral hydrate Methyprylon (withdrawn from use in US & Canada) Bromide Secobarbital Sleep Aids Zolpidem/Zolpidem Tartrate Steroids Prednisone, Prednisolone & Methylprednisolone [high dosage methylprednisolone] Thyroid Carbimazole & active metabolite of carbimazole (Methimazole) Propylthiouracil Thiouracil Levothyroxine Tuberculosis Cycloserine & Isoniazid Ethambutol Rifampin Vitamins B-1 (thiamin) B-12 (Cyanocobalamin) B-6 (pyridoxine) D, vitamin Folic acid K-1, vitamin (Phytonadione) Riboflavin/B2 Miscellaneous Acitretin (Anti-psoriasis) Alcohol/Ethanol Allopurinol Antimony Atropine (Anticholinergic, drying agent) Azapropazone/apazone (Antirheumatic) Baclofen (muscle relaxant) Barbiturate Caffeine Carbetocin (Antihemorrhagic) Chloroform Cisplatin (Anti-cancer) Dapsone (Antileprosy) Hydroxychloroquine (Antirheumatic, lupus) Iodine & Iodides (povidone-iodine, e.g., in a vaginal douche) Ivermectin (Antiparasitic) Nalidixic acid (Urinary Anti-infective) Norsteroids Pyridostigmine (Muscle stimulant) Scopolamine (Motion sickness) Sulfapyridine Timolol (glaucoma med)
*NR: Not Reviewed. This drug has not yet been reviewed by the AAP.

Pregnancy Risk Category B D C C D D B C

Lactation Risk Category L2 L2 L3 L3 NR L5 L3 L3 L2

D D A C B C A A A A(1st, 2nd trim.), C(3rd trim.) C A D C C C B D C C C B C C D

L3 L2 NR L1 L3 L2 L2 NR L1 L2;L4in high doses (may inhibit lactation) L3(do not overdose) L1 L1 L1 NR L3 L2 NR L3 L2 L2 NR L2 NR NR L4 L4 L2 NR L3 L4 NR L2 L3 NR L3

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RGUHS J Pharm Sci | Vol 3 | Issue 1 | JanMar, 2013

S.B. Puranik. et al.: Pregnancy and Lactation......

CONCLUSION Drugs should be avoided by all women who are or might become pregnant. While some medications are known to be harmful when taken during pregnancy, the safety of most medications taken by pregnant women has been difficult 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 other medications a woman takes? Some of the fetuss blood vessels 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 surrounding the villi (intervillous space). Only a thin membrane (placental membrane) separates the mothers blood in the intervillous space from the fetuss blood in the villi. Drugs in the mothers blood can cross this membrane into blood vessels in the villi and pass through the umbilical cord to the fetus. Most drugs that go into the body will also go into the milk, so before any medication is taken, consideration of its effect on baby and whether or 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.

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