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Drug pregnancy categories
From WikEM
(Redirected from Drug ratings in pregnancy)
This categorization system has been superseded by the 2015 FDA Pregnancy and Lactation Labeling Rule
Contents
Background
- The FDA previously assigned letter categories to medications based on their potential for risk to the fetus
- New drugs approved after the 2015 PLLR will not be assigned a pregnancy category.
Table
| Category | Interpretation | Details |
|---|---|---|
| A | Human studies show no risk | Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy |
| B | No evidence of risk in studies | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. |
| C | Risk cannot be ruled out | Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women. |
| D | Positive evidence of risk | Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective. |
| X | Contraindicated in pregnancy | Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant. |
Category A Drugs
Category B Drugs
Antibiotics
- Penicillin V, Penicillin G Benzathine, Amoxicillin, Amoxicillin/Clavulanate, Oxacillin, Ampicillin/Sulbactam, Ticarcillin/Clavulanate, Dicloxacillin
- Ceftriaxone, Cephalexin, Cefazolin, Cefepime, Cefuroxime, Ceftaroline fosamil, Cefdinir, Cefadroxil, Cefpodoxime, Cefprozil
- Clindamycin, Azithromycin
- Metronidazole
- Daptomycin
- Nitrofurantoin, Fosfomycin
- Aztreonam, Meropenem, Ertapenem
- Mupirocin
- Quinupristin/dalfopristin
Other Antimicrobials
- Acyclovir, Famciclovir
- Amphotericin B
- Griseofulvin
- Clotrimazole (topical, vulvovaginal)
- Terbinafine
- Mefloquine
- Permethrin
- Emtricitabine/tenofovir (Truvada)
- Nitazoxanide
Antiemetics and other GI medications
- Metoclopramide
- Ondansetron
- Dimenhydrinate
- Famotidine
- Lansoprazole
- Lactulose
- Psyllium
- Loperamide
- Dicyclomine
Analgesics and other neuro/psych meds
Cardiovascular Medications
Antiplatelet and Anticoagulants
Antidotes
Miscellaneous
- Ipratropium, Budesonide
- Ranitidine, Cimetidine
- Metformin
- Oxybutynin, Tamsulosin, Phenazopyridine
- Bromocriptine
- Glycopyrrolate
Category C Drugs
Includes most medications not listed elsewhere here
Category D Drugs
Antimicrobials
- Gentamicin, Neomycin, Amikacin, Streptomycin
- Trimethoprim-sulfamethoxazole
- Doxycycline
- Fluconazole, Voriconazole
- Primaquine, Hydroxychloroquine
AEDs and other neuro/psych meds
- Phenytoin, Fosphenytoin
- Carbamazepine
- Midazolam, Alprazolam
- Phenobarbital
- Magnesium sulfate (despite being drug-of-choice for eclampsia!)
- Lithium
Cardiovascular
Miscellaneous
- Cortisone, Flunisolide
- Mycophenolate mofetil
- Penicillamine
- Methimazole, Propylthiouracil, Potassium iodide
Category X Drugs
- Valproate
- Methotrexate
- Ribavarin
- Triazolam
- Emergency contraception: Levonorgestrel, Ulipristal
