Difference between revisions of "Drug pregnancy categories"

(Cardiovascular Medications)
(Other Antimicrobials)
 
(33 intermediate revisions by the same user not shown)
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==Category A Drugs==
 
==Category A Drugs==
*[[Thiamine]], [[Pyridoxine]]
+
*[[Thiamine]], [[Pyridoxine]], [[Folic acid]]
 
*[[Docusate]], [[Senna]], [[Bisacodyl]]
 
*[[Docusate]], [[Senna]], [[Bisacodyl]]
 
*[[Dextromethorphan]]
 
*[[Dextromethorphan]]
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==Category B Drugs==
 
==Category B Drugs==
 
===Antibiotics===
 
===Antibiotics===
*[[Penicillin V]], [[Penicillin G Benzathine]], [[Amoxicillin]], [[Amoxicillin/Clavulanate]], [[Oxacillin]], [[Ampicillin]], [[Ampicillin/Sulbactam]], [[Ticarcillin/Clavulanate]], [[Dicloxacillin]], [[Cloxacillin]]
+
*[[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]]
 
*[[Ceftriaxone]], [[Cephalexin]], [[Cefazolin]], [[Cefepime]], [[Cefuroxime]], [[Ceftaroline fosamil]], [[Cefdinir]], [[Cefadroxil]], [[Cefpodoxime]], [[Cefprozil]], [[Ceftolozane/tazobactam]], [[Cefditoren]]
*[[Clindamycin]], [[Azithromycin]], [[Fidaxomicin]]
+
*[[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]]
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===Other Antimicrobials===
 
===Other Antimicrobials===
 
*[[Acyclovir]], [[Famciclovir]]
 
*[[Acyclovir]], [[Famciclovir]]
 +
*[[Valacyclovir]]
 
*[[Amphotericin B]]
 
*[[Amphotericin B]]
*[[Griseofulvin]]
 
 
*[[Clotrimazole]] (topical, vulvovaginal)
 
*[[Clotrimazole]] (topical, vulvovaginal)
 
*[[Terbinafine]]
 
*[[Terbinafine]]
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*[[Emtricitabine/tenofovir]] (Truvada)
 
*[[Emtricitabine/tenofovir]] (Truvada)
 
*[[Nitazoxanide]]
 
*[[Nitazoxanide]]
 +
*[[Praziquantel]]
 +
*[[Raxibacumab]]
  
 
===Antiemetics and other GI medications===
 
===Antiemetics and other GI medications===
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*[[Dimenhydrinate]]
 
*[[Dimenhydrinate]]
 
*[[Famotidine]]
 
*[[Famotidine]]
*[[Lansoprazole]]
+
*[[Lansoprazole]], [[Pantoprazole]]
*[[Lactulose]]
+
*[[Lactulose]], [[Psyllium]]
*[[Psyllium]]
 
 
*[[Loperamide]]
 
*[[Loperamide]]
 
*[[Dicyclomine]]
 
*[[Dicyclomine]]
 +
*[[Ursodiol]]
  
 
===Analgesics and other neuro/psych meds===
 
===Analgesics and other neuro/psych meds===
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*[[Benztropine]]
 
*[[Benztropine]]
 
*[[Buspirone]]
 
*[[Buspirone]]
 +
*[[Methylphenidate]]
  
 
===Cardiovascular Medications===
 
===Cardiovascular Medications===
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*[[Sildenafil]]
 
*[[Sildenafil]]
 
*[[Dobutamine]]
 
*[[Dobutamine]]
 +
*[[Sotalol]]
  
 
===Antiplatelet and Anticoagulants===
 
===Antiplatelet and Anticoagulants===
 
*[[Clopidogrel]], [[Prasugrel]]
 
*[[Clopidogrel]], [[Prasugrel]]
 +
*[[Eptifibatide]]
 
*[[Ticlopidine]]
 
*[[Ticlopidine]]
 +
*[[Tirofiban]]
 
*[[Apixaban]]
 
*[[Apixaban]]
 
*[[Argatroban]], [[Bivalirudin]]
 
*[[Argatroban]], [[Bivalirudin]]
 
*[[Fondaparinux]]
 
*[[Fondaparinux]]
 +
*[[Enoxaparin]]
  
 
===Antidotes===
 
===Antidotes===
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*[[Levocarnitine]]
 
*[[Levocarnitine]]
 
*[[Cyproheptadine]]
 
*[[Cyproheptadine]]
 +
*[[Idarucizumab]]
 +
*[[N-acetylcysteine]]
 +
 
===Miscellaneous===
 
===Miscellaneous===
 
*[[Ipratropium]], [[Budesonide]]
 
*[[Ipratropium]], [[Budesonide]]
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*[[Montelukast]]
 
*[[Montelukast]]
 
*[[Desmopressin]]
 
*[[Desmopressin]]
 +
*[[Glucagon]]
 +
*[[Prilocaine]]
 +
*[[Propofol]]
 +
*[[Sodium polystyrene sulfonate]]
 +
*[[Sulfasalazine]]
  
 
==Category C Drugs==
 
==Category C Drugs==
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==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]], [[Hydroxychloroquine]]
 
*[[Primaquine]], [[Hydroxychloroquine]]
 +
 
===AEDs and other neuro/psych meds===
 
===AEDs and other neuro/psych meds===
 
*[[Phenytoin]], [[Fosphenytoin]]
 
*[[Phenytoin]], [[Fosphenytoin]]
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*[[Lithium]]
 
*[[Lithium]]
 
*[[Topiramate]]
 
*[[Topiramate]]
 +
*[[Pentobarbital]]
  
 
===Cardiovascular===
 
===Cardiovascular===
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*[[Bismuth subsalicylate]] (3rd trimester only)
 
*[[Bismuth subsalicylate]] (3rd trimester only)
 
*[[Cyclophosphamide]]
 
*[[Cyclophosphamide]]
 +
*[[Ibuprofen]] (3rd trimester only, otherwise category C)
 +
*[[Meloxicam]] (if >30wks, otherwise category C)
 +
*[[Tamoxifen]]
  
 
==Category X Drugs==
 
==Category X Drugs==
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*[[Aliskiren]]
 
*[[Aliskiren]]
 
*Emergency contraception: [[Levonorgestrel]], [[Ulipristal]]
 
*Emergency contraception: [[Levonorgestrel]], [[Ulipristal]]
 +
*[[Griseofulvin]]
 +
*[[Methylene blue]]
 +
*[[Oxytocin]]
 +
*[[Riociguat]]
  
 
==See Also==
 
==See Also==

Latest 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

Category B Drugs

Antibiotics

Other Antimicrobials

Antiemetics and other GI medications

Analgesics and other neuro/psych meds

Cardiovascular Medications

Antiplatelet and Anticoagulants

Antidotes

Miscellaneous

Category C Drugs

Includes most medications not listed elsewhere here

Category D Drugs

Antimicrobials

AEDs and other neuro/psych meds

Cardiovascular

Miscellaneous

Category X Drugs

See Also

External Links

References