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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).
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) .
(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.