Drug pregnancy categories: Difference between revisions
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''This categorization system has been superseded by the 2015 FDA [[Pregnancy and lactation drug labeling|Pregnancy and Lactation Labeling Rule]]'' | |||
==Background== | ==Background== | ||
FDA | *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== | ==Table== | ||
| Line 20: | Line 23: | ||
==Category A Drugs== | ==Category A Drugs== | ||
*[[Thiamine]], [[Pyridoxine]] | *[[Thiamine]], [[Pyridoxine]], [[Folic acid]] | ||
*[[Docusate]], [[Senna]], [[Bisacodyl]] | *[[Docusate]], [[Senna]], [[Bisacodyl]] | ||
*[[Dextromethorphan]] | *[[Dextromethorphan]] | ||
*[[Doxylamine]] | *[[Doxylamine]] | ||
*[[Levothyroxine]] | |||
==Category B Drugs== | ==Category B Drugs== | ||
===Antibiotics=== | ===Antibiotics=== | ||
*[[Penicillin V]], [[Penicillin G Benzathine]], [[Amoxicillin]], [[Amoxicillin/Clavulanate]], [[Oxacillin]], [[Ampicillin/Sulbactam]], [[Ticarcillin/Clavulanate]], [[Dicloxacillin]] | *[[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]] | *[[Ceftriaxone]], [[Cephalexin]], [[Cefazolin]], [[Cefepime]], [[Cefuroxime]], [[Ceftaroline fosamil]], [[Cefdinir]], [[Cefadroxil]], [[Cefpodoxime]], [[Cefprozil]], [[Ceftolozane/tazobactam]], [[Cefditoren]] | ||
*[[Clindamycin]], [[Azithromycin]] | *[[Clindamycin]], [[Azithromycin]], [[Erythromycin]], [[Fidaxomicin]], [[Spiramycin]] | ||
*[[Metronidazole]] | *[[Metronidazole]] | ||
*[[Daptomycin]] | *[[Daptomycin]] | ||
*[[Nitrofurantoin]], [[Fosfomycin]] | *[[Nitrofurantoin]], [[Fosfomycin]] | ||
*[[Aztreonam]], [[Meropenem]], [[Ertapenem]] | *[[Aztreonam]], [[Meropenem]], [[Ertapenem]], [[Doripenem]] | ||
*[[Mupirocin]] | *[[Mupirocin]] | ||
* [[Quinupristin/dalfopristin]] | *[[Quinupristin/dalfopristin]] | ||
===Other Antimicrobials=== | ===Other Antimicrobials=== | ||
*[[Acyclovir]], [[Famciclovir]] | *[[Acyclovir]], [[Famciclovir]] | ||
*[[Valacyclovir]] | |||
*[[Amphotericin B]] | *[[Amphotericin B]] | ||
*[[Clotrimazole]] (topical, vulvovaginal) | *[[Clotrimazole]] (topical, vulvovaginal) | ||
*[[Terbinafine]] | *[[Terbinafine]] | ||
*[[Mefloquine]] | *[[Mefloquine]] | ||
*[[Permethrin]] | |||
*[[Emtricitabine/tenofovir]] (Truvada) | |||
*[[Nitazoxanide]] | |||
*[[Praziquantel]] | |||
*[[Raxibacumab]] | |||
===Antiemetics and other GI medications=== | ===Antiemetics and other GI medications=== | ||
*[[Metoclopramide]] | *[[Metoclopramide]] | ||
| Line 48: | Line 59: | ||
*[[Dimenhydrinate]] | *[[Dimenhydrinate]] | ||
*[[Famotidine]] | *[[Famotidine]] | ||
*[[Lansoprazole]] | *[[Lansoprazole]], [[Pantoprazole]] | ||
*[[Lactulose]] | *[[Lactulose]], [[Psyllium]] | ||
*[[Loperamide]] | *[[Loperamide]] | ||
*[[Dicyclomine]] | |||
*[[Ursodiol]] | |||
===Analgesics and other neuro/psych meds=== | ===Analgesics and other neuro/psych meds=== | ||
*[[Acetaminophen]] | *[[Acetaminophen]] | ||
| Line 61: | Line 74: | ||
*[[Clozapine]] | *[[Clozapine]] | ||
*[[Benztropine]] | *[[Benztropine]] | ||
*[[Buspirone]] | |||
*[[Methylphenidate]] | |||
===Cardiovascular Medications=== | ===Cardiovascular Medications=== | ||
*[[Hydrochlorothiazide]] | *[[Hydrochlorothiazide]] | ||
*[[Fenoldopam]] | *[[Fenoldopam]] | ||
*[[Torsemide]] | *[[Torsemide]], [[Ethacrynic acid]], [[Amiloride]] | ||
*[[Epoprostenol (prostacyclin)]] | *[[Epoprostenol (prostacyclin)]] | ||
*[[Sildenafil]] | |||
*[[Dobutamine]] | |||
*[[Sotalol]] | |||
===Antiplatelet and Anticoagulants=== | ===Antiplatelet and Anticoagulants=== | ||
*[[Clopidogrel]] | *[[Clopidogrel]], [[Prasugrel]] | ||
*[[ | *[[Eptifibatide]] | ||
*[[Ticlopidine]] | |||
*[[Tirofiban]] | |||
*[[Apixaban]] | *[[Apixaban]] | ||
*[[Argatroban]] | *[[Argatroban]], [[Bivalirudin]] | ||
*[[Fondaparinux]] | *[[Fondaparinux]] | ||
*[[Enoxaparin]] | |||
===Antidotes=== | ===Antidotes=== | ||
| Line 78: | Line 100: | ||
*[[Levocarnitine]] | *[[Levocarnitine]] | ||
*[[Cyproheptadine]] | *[[Cyproheptadine]] | ||
*[[Idarucizumab]] | |||
*[[N-acetylcysteine]] | |||
===Miscellaneous=== | ===Miscellaneous=== | ||
*[[Ipratropium]] | *[[Ipratropium]], [[Budesonide]] | ||
*[[Ranitidine]], [[Cimetidine] | *[[Ranitidine]], [[Cimetidine]] | ||
*[[Metformin]] | *[[Metformin]] | ||
*[[Oxybutynin]], [[Tamsulosin]], [[Phenazopyridine]] | *[[Oxybutynin]], [[Tamsulosin]], [[Phenazopyridine]] | ||
*[[Bromocriptine]] | |||
*[[Glycopyrrolate]] | |||
*[[Montelukast]] | |||
*[[Desmopressin]] | |||
*[[Glucagon]] | |||
*[[Prilocaine]] | |||
*[[Propofol]] | |||
*[[Sodium polystyrene sulfonate]] | |||
*[[Sulfasalazine]] | |||
==Category C Drugs== | ==Category C Drugs== | ||
''Includes most medications not listed elsewhere here'' | '''Includes most medications not listed elsewhere here''' | ||
==Category D Drugs== | ==Category D Drugs== | ||
===Antimicrobials=== | ===Antimicrobials=== | ||
*[[Gentamicin]], [[Neomycin]], [[Amikacin]], [[Streptomycin]] | *[[Gentamicin]], [[Neomycin]], [[Amikacin]], [[Streptomycin]], [[Kanamycin]] | ||
*[[Trimethoprim-sulfamethoxazole]] | *[[Trimethoprim-sulfamethoxazole]] | ||
*[[Doxycycline]] | *[[Doxycycline]], [[Minocycline]], [[Tetracycline]], [[Tigecycline]] | ||
*[[Fluconazole]], [[Voriconazole]] | *[[Fluconazole]], [[Voriconazole]] | ||
*[[Primaquine]] | *[[Primaquine]], [[Hydroxychloroquine]] | ||
===AEDs and other neuro/psych meds=== | ===AEDs and other neuro/psych meds=== | ||
*[[Phenytoin]], [[Fosphenytoin]] | *[[Phenytoin]], [[Fosphenytoin]] | ||
*[[Carbamazepine]] | *[[Carbamazepine]] | ||
*[[Midazolam]], [[Alprazolam]] | *[[Midazolam]], [[Alprazolam]], [[Clonazepam]], [[Diazepam]] | ||
*[[Phenobarbital]] | *[[Phenobarbital]] | ||
*[[Magnesium sulfate]] (despite being drug-of-choice for eclampsia!) | *[[Magnesium sulfate]] (despite being drug-of-choice for eclampsia!) | ||
*[[Lithium]] | *[[Lithium]] | ||
*[[Topiramate]] | |||
*[[Pentobarbital]] | |||
===Cardiovascular=== | ===Cardiovascular=== | ||
*[[Amiodarone]] | *[[Amiodarone]] | ||
*[[Atenolol]] | *[[Atenolol]] | ||
*[[Lisinopril]], [[Captopril]], [[Enalapril]] | *[[Lisinopril]], [[Captopril]], [[Enalapril]], [[Benazepril]] | ||
*[[Losartan]], [[Valsartan]] | *[[Losartan]], [[Valsartan]] | ||
*[[Aspirin]] | *[[Aspirin]] (3rd trimester) | ||
*[[Edoxaban]] | *[[Edoxaban]] | ||
*[[Warfarin]] | |||
===Miscellaneous=== | ===Miscellaneous=== | ||
*[[Cortisone]], [[Flunisolide]] | *[[Cortisone]], [[Flunisolide]] | ||
*[[Mycophenolate mofetil]] | *[[Mycophenolate mofetil]] | ||
*[[Penicillamine]] | *[[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 Drugs== | ==Category X Drugs== | ||
*[[Valproate]] | *[[Valproate]] | ||
*[[Methotrexate]] | *[[Methotrexate]] | ||
*[[ | *[[Ribavirin]] | ||
*[[Triazolam]] | *[[Triazolam]] | ||
*[[Bosentan]] | |||
*[[Aliskiren]] | |||
*Emergency contraception: [[Levonorgestrel]], [[Ulipristal]] | |||
*[[Griseofulvin]] | |||
*[[Methylene blue]] | |||
*[[Oxytocin]] | |||
*[[Riociguat]] | |||
==See Also== | ==See Also== | ||
*[[ | *[[Pregnancy and lactation drug labeling]] | ||
==External Links== | |||
==References== | |||
<references/> | |||
[[Category:OBGYN]] | [[Category:OBGYN]] | ||
[[Category:Pharmacology]] | [[Category:Pharmacology]] | ||
Revision as of 23:22, 23 September 2019
This categorization system has been superseded by the 2015 FDA Pregnancy and Lactation Labeling Rule
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
- Thiamine, Pyridoxine, Folic acid
- Docusate, Senna, Bisacodyl
- Dextromethorphan
- Doxylamine
- Levothyroxine
Category B Drugs
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
Analgesics and other neuro/psych meds
- 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
Miscellaneous
- Ipratropium, Budesonide
- Ranitidine, Cimetidine
- Metformin
- Oxybutynin, Tamsulosin, Phenazopyridine
- Bromocriptine
- Glycopyrrolate
- Montelukast
- Desmopressin
- Glucagon
- Prilocaine
- Propofol
- Sodium polystyrene sulfonate
- Sulfasalazine
Category C Drugs
Includes most medications not listed elsewhere here
Category D Drugs
Antimicrobials
- Gentamicin, Neomycin, Amikacin, Streptomycin, Kanamycin
- Trimethoprim-sulfamethoxazole
- Doxycycline, Minocycline, Tetracycline, Tigecycline
- Fluconazole, Voriconazole
- Primaquine, Hydroxychloroquine
AEDs and other neuro/psych meds
- 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 Drugs
- Valproate
- Methotrexate
- Ribavirin
- Triazolam
- Bosentan
- Aliskiren
- Emergency contraception: Levonorgestrel, Ulipristal
- Griseofulvin
- Methylene blue
- Oxytocin
- Riociguat