Pregnancy Categories Medicine

Some women need to take medicines during pregnancy for health problems like diabetes, depression, morning sickness or seizures. Always talk with your doctor, nurse, or pharmacist before taking any medicines, vitamins or herbs. Don’t stop taking your prescription medicines unless your healthcare provider says that it is OK.

Pregnancy can be an exciting time. However, this time can also make you feel uneasy if you are not sure how your medicines will affect your baby. Not all medicines are safe to take when you are pregnant. Even headache or pain medicine may not be safe during certain times in your pregnancy.

Always talk to your doctor, nurse, or pharmacist before you take any medicines, herbs, or vitamins. Don’t stop taking your medicines until your healthcare provider says that it is OK.

FDA Pregnancy Risk Categories.

In 1979, the FDA established five letter risk categories – A, B, C, D or X – to indicate the potential of a drug to cause birth defects if used during pregnancy. The categories were determined by assessing the reliability of documentation and the risk to benefit ratio. These categories did not take into account any risks from pharmaceutical agents or their metabolites in breast milk. In the drug product label, this information was found in the section “Use in Specific Populations”.

The former pregnancy categories, which still may be found in some package inserts, were as follows:

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

Example drugs or substances: levothyroxine, folic acid, liothyronine,Thiamine, Pyridoxine, Docusate, Senna, Bisacodyl, Dextromethorphan, Doxylamine, Isoniazid

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk

Antibiotics
Penicillin V, Penicillin G Benzathine, Amoxicillin, Amoxicillin/Clavulanate, Oxacillin, Ampicillin, Ampicillin/Sulbactam, Ticarcillin/Clavulanate, Dicloxacillin, Cloxacillin, Nafcillin, Ceftriaxone, Cephalexin, Cefazolin, Cefepime, Cefuroxime, Ceftaroline fosamil, Cefdinir, Cefadroxil, Cefpodoxime, Cefprozil, Ceftolozane/tazobactam, Cefditoren Clindamycin, Azithromycin, Erythromycin, Fidaxomicin, Spiramycin Metronidazole Daptomycin, Nitrofurantoin, Fosfomycin Aztreonam, Meropenem, Ertapenem, Doripenem Mupirocin Quinupristin/dalfopristin

Other Antimicrobials
Acyclovir, Famciclovir, Valacyclovir, Amphotericin B, Clotrimazole (topical, vulvovaginal), Terbinafine, Mefloquine Permethrin, Emtricitabine/tenofovir (Truvada), Nitazoxanide, Praziquantel, Raxibacumab

Antiemetics and other GI medications
Metoclopramide, Ondansetron, Dimenhydrinate, Famotidine, Lansoprazole, Pantoprazole, Lactulose, Psyllium, Loperamide, Dicyclomine, Ursodiol, Sucralfate
Analgesics and other Drugs
Acetaminophen, Ketamine, Meperidine, Cyclobenzaprine, Indomethacin, Meclizine, Clozapine, Benztropine, Buspirone, Methylphenidate

Cardiovascular Medications
Hydrochlorothiazide, Fenoldopam, Torsemide, Ethacrynic acid, Amiloride, Epoprostenol (prostacyclin), Sildenafil, Dobutamine, Sotalol

Antiplatelet and Anticoagulants
Clopidogrel, Prasugrel, Eptifibatide, Ticlopidine, Tirofiban, Apixaban, Argatroban, Bivalirudin, Fondaparinux, Enoxaparin, Antidotes, EDTA, Levocarnitine, Cyproheptadine, Idarucizumab, N-acetylcysteine

Miscellaneous
Ipratropium, Budesonide, Ranitidine, Cimetidine, Metformin, Oxybutynin, Tamsulosin, Phenazopyridine, Bromocriptine, Glycopyrrolate, Montelukast, Desmopressin, Glucagon, Prilocaine, Propofol, Sodium polystyrene sulfonate, Sulfasalazine

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

Example drugs: gabapentin, amlodipine, trazodone

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

Example drugs:

Antimicrobials
Gentamicin, Neomycin, Amikacin, Streptomycin, Kanamycin, Trimethoprim-sulfamethoxazole, Doxycycline, Minocycline, Tetracycline, Tigecycline, Fluconazole, Voriconazole, Primaquine, Hydroxychloroquine

AEDs and other neuro/psych medicines
Phenytoin, Fosphenytoin, Carbamazepine, Midazolam, Alprazolam, Clonazepam, Diazepam, Phenobarbital, Magnesium sulfate (despite being drug-of-choice for eclampsia), Lithium, Topiramate, Pentobarbital,

Cardiovascular
Amiodarone, Atenolol, Lisinopril, Captopril, Enalapril, Benazepril, Losartan, Valsartan, Aspirin (3rd trimester), Edoxaban, Warfarin

Miscellaneous

Cortisone, Flunisolide, Mycophenolate mofetil, Penicillamine, Methimazole, Propylthiouracil, Potassium iodide, Hydroxyurea, Zoledronate, Bismuth subsalicylate (3rd trimester only), Cyclophosphamide, Ibuprofen (3rd trimester only, otherwise category C), Meloxicam (if >30wks, otherwise category C), Tamoxifen

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

Example drugs: Atorvastatin, Simvastatin, Methotrexate, Finasteride, Valproate, Ribavirin, Triazolam, Bosentan, Aliskiren, Levonorgestrel, Ulipristal, Griseofulvin, Methylene blue, Oxytocin, Riociguat, Isotretinoin