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Food and Drug Administration, (FDA) assigned risk factors (A,B,C,D,X) to different drugs based on the level of risk the drug poses to the fetus. This stratification helps the physician to classify a drug for use during pregnancy (Table 1 & 2).

Drugs & Pregnancy@

Table 1. Principles of classifying drugs into various categories

Category Description

Controlled studies fail to demonstrate a risk to the fetus in the trimester (and there is no evidence of risk in later trimester); the possibility of fetal harm appears remote.

B
Fetal risk not demonstrated in animal studies but there are no controlled studies in pregnant women, or animal reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women during the first trimester (and there is no evidence of risk in later trimesters) .

Either animal studies have revealed adverse effects on the fetus

(teratogenic, embryocidal, or other) and there are no controlled human studies, or studies in animals and women are not available.

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 can not be used or are ineffective).

Studies in animals or humans 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. Table-2 Drugs and Pregnancy Ergotamine Tartrate, Phenobarbital Clomiphene citrate Danazol - Ethinyl estradiol Levonorgestrel Category - Oxytoin, Quinine sulphate - Stanozolol - Vitamin A, Warfarin sodium. Alprazolam - Amikacin sulfate - Amiodarone, Amitriptyline, Aspirin, Atenolol, Captopril Category Colchicine, Doxycycline, Enalapril maleate, Eosinopril, Kanamycin, Lisinopril, Lithium, Lorazepam, Neomycin - Netlimicin, Oxazepam, Ramipril, Tamoxifen, Valproic acid. Acetaminophen - Acyclovir - Adenosine Allopurinol, Aminophyline, Alcohol, Amphetamine Category Antihemophilic factors, Atropine sulfate, BCG, Calcium injectable, Chloroquine, Chlorpheniramine Chlorpromazine, Ciprofloxacine - Clofazimine, Clonidine, Clotrimazole, Dapsone, Dexamethasone - ,

X D C

B
Category

A
Category

Digoxin, Diltiazem Hydrochloride, Ethionamide, Eurosemide, Gentamycin, Guafenesin, Haloperidol, Heparin, Hydralazine, Interferon, Isoniazid Ketoconazole, Levodopa, Mannitol, Mefenamic acid, Mefloquine, Neostigmine, Nifedipine, Norfloxacin, Prazosin, Rifampicin, Streptokinase, Vitamin K, Zidovudine. Amoxycillin, Cefaclor, Cefloperazone, Cephalexin, Ceftiaxone, Cimetidine, Clindamycin, Erythromycin, Famotidine, Indomethacin, Isosorbide, Lactulose, Methyldopa, Metronidazole, Nitrofurantoin, Prednisone, Sucralfate, Spironolactone. Ferrous sulfate, Levothyroxine, Magnesium sulfate injectable, Vitamin B1, Vitamin B6.

Antimicrobials and Pregnancy

The Following Table lists various antimicrobial agents classified according to their safety and their possible toxic effects on fetus in pregnancy. The terms of reference used are: Probably safe indicates that no significant risk to fetus has been documented and these agents become first choice if an antimicrobial therapy is required. Caution indicate that effect on fetus has been documented but can be used at times when benefits of giving outweight associated risks.

Category A. PROBABLY SAFE ]<^m] ^^]<j]<]

Agent
Adverse effect on fetus

Comments All the commone B- lactams may be

1. Penicillin

Allergy:Probabilit y of sensitizing

2. Long acting Penicillin 3. Ampicillin, Amoxycillin

4. Amoxicillin & Clavulanic acid

the fetus - do - do -

described as safe.

No suggestion of increased toxicity

Little information available Best avoid till more experience is reported.

5. Ticarcillin, Carbenicillin Piperacillin. 6. Cloxacillin

7. Cephalexin & other Cephalo-sporins includinginjectable preparation

- do -

Little information available Best avoid till more experience is reported. Little information available on newer agents.

- do - do -

8. Sulphonamides

Safe in first trimester Avoid within two days of delivery

9. Trimethoprim 10. Cotrimoxazole 11. Nitrofurantoin

12. Erythromycin stearate

Risk is more for highly protein bound agents as sulphafurazole. Theoretical risk of megaloblastic anemia.
Considerable experience of safety in first trimester.

Kernicterus

Risky in G-6-PD deficiency

B. AVOID<<]<^m]<^f<g<j]<]<
1. Tetracyclines 2. Streptomycin 3.Ciprofloxacin, Olfloxacin,Pefloxacin 4. Erythromycin estolate
5.Clarithromycin, Azithromycin ,Clindamycin, Lincomycin Discoloration & dysplasia of teeth & bones; cataracts.

Possible hepatotoxicity in mother Little reason to use it as better drugs available Little experience in pregnancy Maternal hepatotoxicity in late pregnancy Maternal pseudo membranous colitis
Possible maternal blood dyscrasias

Ototoxicity

6. Chloramphenicol 7. Quinine

Grey baby syndrome

Possible abortifacient

--

C - CAUTION<<^<]<}_<g<j]<]
1.Gentamycin,Amikaci n,Tobramycin,Netlimi cin

Theoretical risk of Ototoxity

2. Nalidixic acid 3. Vancomycin 4. Metronidazole Theoretical risk of teratogenecity

Use only when very specifically indicated Conflicting datas

Safety data not available for humans

Weigh benefit vs risk