Pregnancy category: Difference between revisions

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Line 31: Line 31:
* [[Acyclovir]]
* [[Acyclovir]]
* [[Adalimumab]]
* [[Adalimumab]]
* [[Alfuzosin]]
* [[Alogliptin]]
* [[Alosetron]]
* [[Alvimopan]]
* [[Amiloride]]
* [[Amiloride]]
*[[Amoxicillin]]
* [[Amoxicillin]]
* [[Antithrombin III]]
* [[Antithrombin III]]
* [[Aprepitant]]
* [[Argatroban]]
* [[Argatroban]]
* [[Atazanavir]]
* [[Atazanavir]]
* [[Azelaic acid]]
* [[Azelaic acid]]
* [[Azithromycin]]
* [[Azithromycin]]
* [[Aztreonam]]
* [[Balsalazide]]
* [[Bivalirudin]]
* [[Bivalirudin]]
* [[Boceprevir]]
* [[Brimonidine]]
* [[Brimonidine]]
* [[Bromocriptine]]
* [[Bromocriptine]]
Line 44: Line 52:
* [[Cabergoline]]
* [[Cabergoline]]
* [[Cefaclor]]
* [[Cefaclor]]
*[[Cefadroxil]]
* [[Cefadroxil]]
* [[Cefazolin]]
* [[Cefazolin]]
* [[Cefdinir]]
* [[Cefdinir]]
*[[Ceftazidime]]
* [[Cefditoren]]
* [[cefoxitin sodium]]
* [[Ceftazidime]]
* [[Certolizumab pegol]]
* [[Chlorthalidone]]
* [[Chlorthalidone]]
* [[Clindamycin]]
* [[Clindamycin]]
Line 56: Line 67:
* [[Dalteparin]]
* [[Dalteparin]]
* [[Daptomycin]]
* [[Daptomycin]]
*[[Desmopressin]]
* [[Desmopressin]]
* [[Dexlansoprazole]]
* [[Dexlansoprazole]]
* [[Dipyridamole]]
* [[Dipyridamole]]
* [[Dobutamine]]
* [[Dobutamine]]
* [[Doripenem]]
* [[Doripenem]]
* [[Elvitegravir]]
* [[Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate]]
* [[Elvitegravir, Cobicistat, Emtricitabine, And Tenofovir Disoproxil Fumarate]]
* [[Emtricitabine and tenofovir disoproxil fumarate]]
* [[Emtricitabine and tenofovir disoproxil fumarate]]
Line 88: Line 100:
* [[Insulin detemir]]
* [[Insulin detemir]]
* [[Insulin lispro]]
* [[Insulin lispro]]
* [[Iopamidol]]
* [[Isosorbide mononitrate]]
* [[Isosorbide mononitrate]]
*[[Ivacaftor]]
* [[Lamotrigine]]
* [[Lamotrigine]]
* [[Lepirudin]]
* [[Lepirudin]]
Line 100: Line 114:
* [[Meropenem]]
* [[Meropenem]]
* [[Mesalamine]]
* [[Mesalamine]]
* [[Mesna]]
* [[Metformin]]
* [[Metformin]]
* [[Methyclothiazide]]
* [[Methyclothiazide]]
Line 107: Line 122:
* [[Metronidazole]]
* [[Metronidazole]]
* [[Metronidazole Topical]]
* [[Metronidazole Topical]]
* [[Miglitol]]
* [[Mupirocin]]
* [[Mupirocin]]
* [[Mycophenolate]]
* [[Mycophenolate]]
Line 123: Line 139:
* [[Praziquantel]]
* [[Praziquantel]]
* [[Progesterone]]
* [[Progesterone]]
* [[Raxibacumab]]
* [[Retapamulin]]
* [[Retapamulin]]
* [[Rifabutin]]
* [[Rifabutin]]
Line 131: Line 148:
* [[Sitagliptin]]
* [[Sitagliptin]]
* [[Sofosbuvir]]
* [[Sofosbuvir]]
* [[Somatropin]]
* [[Sotalol]]
* [[Sotalol]]
* [[Sulfasalazine]]
* [[Sulfasalazine]]
* [[Tadalafil]]
* [[Tadalafil]]
* [[Tamsulosin]]
* [[Tamsulosin]]
* [[Teduglutide]]
* [[Telbivudine]]
* [[Telbivudine]]
* [[Telmisartan]]
* [[Telmisartan]]
Line 148: Line 167:
* [[Valacyclovir]]
* [[Valacyclovir]]
* [[Vardenafil]]
* [[Vardenafil]]
* [[Velaglucerase alfa]]
* [[Vorapaxar]]
* [[Vorapaxar]]


Line 155: Line 175:
* [[Acetazolamide]]
* [[Acetazolamide]]
* [[Acetaminophen and Oxycodone]]
* [[Acetaminophen and Oxycodone]]
* [[Aclidinium bromide]]
* [[Adapalene]]
* [[Adapalene]]
* [[Adapalene and Benzoyl peroxide]]
* [[Adapalene and Benzoyl peroxide]]
Line 160: Line 181:
* [[Adenosine]]
* [[Adenosine]]
* [[Albuterol]]
* [[Albuterol]]
* [[Aldesleukin]]
* [[Alendronate]]
* [[Alendronate]]
* [[Allopurinol]]
* [[Allopurinol]]
* [[Almotriptan]]
* [[Alteplase]]
* [[Alteplase]]
* [[Amantadine]]
* [[Amantadine]]
* [[Amifostine]]
* [[Aminocaproic acid]]
* [[Aminocaproic acid]]
* [[Amlodipine]]
* [[Amlodipine]]
Line 170: Line 194:
* [[Antihemophilic factor]]
* [[Antihemophilic factor]]
* [[Antipyrine/Benzocaine]]
* [[Antipyrine/Benzocaine]]
*[[Apomorphine hydrochloride]]
* [[Apraclonidine]]
* [[Apomorphine hydrochloride]]
* [[Aripiprazole]]
* [[Aripiprazole]]
* [[Armodafinil]]
* [[Armodafinil]]
* [[Asparaginase]]
* [[Atomoxetine]]
* [[Atomoxetine]]
* [[Atovaquone]]
* [[Azelastine]]
* [[Azelastine]]
*[[Bacitracin]]
* [[Bacitracin]]
* [[BCG vaccine]]
* [[BCG vaccine]]
* [[Becaplermin]]
* [[Beclometasone dipropionate]]
* [[Beclometasone dipropionate]]
* [[Betaine]]
* [[Betaine]]
Line 183: Line 211:
* [[Bimatoprost]]
* [[Bimatoprost]]
* [[Bisoprolol]]
* [[Bisoprolol]]
* [[Blinatumomab]]
* [[Botulinum toxin]]
* [[Botulinum toxin]]
* [[Brinzolamide]]
* [[Brinzolamide]]
Line 188: Line 217:
* [[Bumetanide]]
* [[Bumetanide]]
* [[Buprenorphine Hydrochloride, Naloxone Hydrochloride]]
* [[Buprenorphine Hydrochloride, Naloxone Hydrochloride]]
*[[Butorphanol]]
* [[Butalbital]]
* [[Butorphanol]]
* [[Calcipotriol]]
* [[Calcipotriol]]
* [[Carbidopa and Levodopa]]
* [[Carbidopa and Levodopa]]
Line 210: Line 240:
* [[Crotamiton]]
* [[Crotamiton]]
* [[Dabigatran]]
* [[Dabigatran]]
* [[Dacarbazine]]
* [[Darifenacin]]
* [[Darifenacin]]
* [[Darunavir]]
* [[Darunavir]]
* [[Delavirdine]]
* [[Deferasirox]]
* [[Desirudin]]
* [[Desirudin]]
* [[Desonide]]
* [[Desonide]]
* [[Desoximetasone]]
* [[Desvenlafaxine]]
* [[Desvenlafaxine]]
* [[Dexmethylphenidate]]
* [[Dexmethylphenidate]]
Line 220: Line 254:
* [[Diclofenamide]]
* [[Diclofenamide]]
* [[Diflunisal]]
* [[Diflunisal]]
* [[Difluprednate]]
* [[Digoxin]]
* [[Digoxin]]
* [[Digoxin immune fab]]
* [[Digoxin immune fab]]
Line 232: Line 267:
* [[Doxazosin]]
* [[Doxazosin]]
* [[Duloxetine]]
* [[Duloxetine]]
* [[Eflornithine]]
* [[Eletriptan]]
* [[Eletriptan]]
* [[Enalapril/ Felodipine]] (first trimester)
* [[Enalapril/ Felodipine]] (first trimester)
Line 242: Line 278:
* [[Eszopiclone]]
* [[Eszopiclone]]
* [[Ethambutol]]
* [[Ethambutol]]
* [[Etidronic acid]]
* [[Etodolac]]
* [[Etodolac]]
* [[Exenatide]]
* [[Exenatide]]
Line 259: Line 296:
* [[Fluticasone]]
* [[Fluticasone]]
* [[Fluticasone/salmeterol]]
* [[Fluticasone/salmeterol]]
* [[Folinic acid]]
* [[Formoterol]]
* [[Formoterol]]
* [[Foscarnet]]
* [[Foscarnet]]
* [[Frovatriptan]]
* [[Frovatriptan]]
* [[Furosemide]]
* [[Furosemide]]
* [[Gallium nitrate]]
* [[Gabapentin]]
* [[Gabapentin]]
* [[Gadobutrol]]
* [[Gadofosveset]]
* [[Ganciclovir]]
* [[Ganciclovir]]
* [[Gatifloxacin]]
* [[Gatifloxacin]]
Line 269: Line 310:
* [[Glimepiride]]
* [[Glimepiride]]
* [[Glipizide]]
* [[Glipizide]]
* [[Glucarpidase]]
* [[Halobetasol]]
* [[Heparin]]
* [[Heparin]]
* [[Hirudin]]
* [[Hirudin]]
* [[8-Hydroxyquinoline]]
* [[Hydralazine]]
* [[Hydralazine]]
* [[Hydrocodone]]
* [[Hydrocodone]]
Line 277: Line 321:
* [[Ibandronic acid]]
* [[Ibandronic acid]]
* [[Ibutilide]]
* [[Ibutilide]]
* [[Icatibant]]
* [[Imipenem cilastatin]]
* [[Imipenem cilastatin]]
* [[Imiquimod]]
* [[Imiquimod]]
* [[Indomethacin]]
* [[Indomethacin]]
* [[Ingenol mebutate]]
* [[Insulin glargine]]
* [[Insulin glargine]]
* [[Insulin glulisine]]
* [[Insulin glulisine]]
Line 287: Line 333:
* [[Interferon beta-1a]]
* [[Interferon beta-1a]]
* [[Interferon beta-1b]]
* [[Interferon beta-1b]]
*[[Interferon gamma]]
* [[Interferon gamma]]
* [[Ipratropium Bromide And Albuterol]]
* [[Ipratropium Bromide And Albuterol]]
* [[Isosorbide dinitrate]]
* [[Isosorbide dinitrate]]
Line 299: Line 345:
* [[Levalbuterol]]
* [[Levalbuterol]]
* [[levetiracetam]]
* [[levetiracetam]]
* [[Linaclotide]]
* [[Lindane]]
* [[Linezolid]]
* [[Linezolid]]
* [[Liraglutide]]
* [[Liraglutide]]
Line 306: Line 354:
* [[Lovaza]]
* [[Lovaza]]
* [[Lubiprostone]]
* [[Lubiprostone]]
* [[Mafenide]]
* [[Mannitol]]
* [[Mannitol]]
* [[Mecamylamine]]
* [[Mecamylamine]]
* [[Mecasermin]]
* [[Mefenamic acid]]
* [[Mefenamic acid]]
* [[Meloxicam]]
* [[Meloxicam]]
* [[Methazolamide]]
* [[Methazolamide]]
* [[Methenamine]]
* [[Methocarbamol]]
* [[Methocarbamol]]
* [[Methoxy polyethylene glycol-epoetin beta]]
* [[Metirosine]]
* [[Metoprolol succinate]]
* [[Metoprolol succinate]]
* [[Metyrapone]]
* [[Mexiletine]]
* [[Mexiletine]]
* [[Minoxidil]]
* [[Minoxidil]]
* [[Mivacurium chloride]]
* [[Modafinil]]
* [[Modafinil]]
* [[Mometasone]]
* [[Mometasone]]
* [[Moxifloxacin]]
* [[Moxifloxacin]]
* [[Moxifloxacin ophthalmic]]
* [[Moxifloxacin ophthalmic]]
* [[Nabilone]]
* [[Nabumetone]]
* [[Nabumetone]]
* [[Nadolol]]
* [[Nadolol]]
* [[Naltrexone]]
* [[Naltrexone]]
* [[Naproxen and esomeprazole magnesium]]
* [[Naproxen and esomeprazole magnesium]]
* [[Naratriptan]]
* [[Nebivolol]]
* [[Nebivolol]]
* [[Nesiritide]]
* [[Nesiritide]]
* [[Netupitant and palonosetron]],
* [[Niacin extended release]]
* [[Niacin extended release]]
* [[Nicardipine]]
* [[Nicardipine]]
* [[Nifedipine]]
* [[Nifedipine]]
* [[Nilutamide]]
* [[Nisoldipine]]
* [[Nisoldipine]]
* [[Nitroprusside]]
* [[Nitroprusside]]
* [[Norfloxacin]]
* [[Norfloxacin]]
* [[Nystatin]]
* [[Nystatin]]
* [[Ofatumumab]]
* [[Ofloxacin]]
* [[Ofloxacin]]
* [[Olanzapine]]
* [[Olanzapine]]
* [[Olodaterol]]
* [[Olopatadine]]
* [[Olopatadine]]
* [[Omeprazole]]
* [[Omeprazole]]
Line 342: Line 403:
* [[Oxytocin]]
* [[Oxytocin]]
* [[Paliperidone]]
* [[Paliperidone]]
* [[Palifermin]]
* [[Palivizumab]]
* [[Palivizumab]]
* [[Papaverine]]
* [[Pasireotide]]
* [[Pegfilgrastim]]
* [[Pegfilgrastim]]
* [[Pegloticase]]
* [[Pegvisomant]]
* [[Penbutolol]]
* [[Penbutolol]]
* [[Panitumumab]]
* [[Pegaspargase]]
* [[Pegylated interferon alfa-2b]]
* [[Pentamidine Isethionate]]
* [[Pentamidine Isethionate]]
* [[Pentoxifylline]]
* [[Pentoxifylline]]
* [[Perampanel]]
* [[Phenylephrine]]
* [[Phenylephrine]]
* [[Pilocarpine]]
* [[Pilocarpine]]
Line 355: Line 425:
* [[Polythiazide/Reserpine]]
* [[Polythiazide/Reserpine]]
* [[Potassium chloride]]
* [[Potassium chloride]]
*[[Pralidoxime]]
* [[Pralidoxime]]
* [[Pramipexole]]
* [[Pramipexole]]
* [[Prazosin]]
* [[Prazosin]]
Line 372: Line 442:
* [[Ranibizumab]]
* [[Ranibizumab]]
* [[Ranolazine]]
* [[Ranolazine]]
* [[Rasagiline]]
* [[Repaglinide]]
* [[Repaglinide]]
* [[Repaglinide and Metformin hydrochloride]]
* [[Repaglinide and Metformin hydrochloride]]
Line 377: Line 448:
* [[Reteplase]]
* [[Reteplase]]
* [[Rifaximin]]
* [[Rifaximin]]
* [[Rilonacept]]
* [[Rimantadine]]
* [[Rimantadine]]
* [[Rimexolone]]
* [[Risedronate]]
* [[Risedronate]]
* [[Rituximab]]
* [[Rituximab]]
* [[Rivaroxaban]]
* [[Rivaroxaban]]
* [[Romiplostim]]
* [[Ropinirole]]
* [[Ropinirole]]
* [[Rosiglitazone]]
* [[Rosiglitazone]]
* [[Rufinamide]]
* [[Sacrosidase]]
* [[Scopolamine]]
* [[Scopolamine]]
* [[Sertraline]]
* [[Sertraline]]
* [[Sevelamer]]
* [[Sevelamer]]
* [[Sibutramine]]
* [[Sibutramine]]
*[[Siltuximab]]
* [[Solifenacin]]
* [[Solifenacin]]
* [[Spironolactone]]
* [[Spironolactone]]
Line 393: Line 470:
* [[Sumatriptan]]
* [[Sumatriptan]]
* [[Tacrolimus]]
* [[Tacrolimus]]
* [[Tafluprost]]
* [[Tbo-filgrastim]]
* [[Telithromycin]]
* [[Telithromycin]]
* [[Tenecteplase]]
* [[Tenecteplase]]
* [[Terazosin]]
* [[Terazosin]]
* [[Tiagabine]]
* [[Ticagrelor]]
* [[Ticagrelor]]
* [[Timolol]]
* [[Timolol]]
* [[Tipranavir]]
* [[Tizanidine]]
* [[Tizanidine]]
* [[Tocilizumab]]
* [[Tolterodine]]
* [[Tolterodine]]
* [[Tolvaptan]]
* [[Tolvaptan]]
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* [[Triamcinolone acetonide]]
* [[Triamcinolone acetonide]]
* [[Triamterene]]
* [[Triamterene]]
* [[Trifluoperazine]]
* [[Trifluridine]]
* [[Trifluridine]]
* [[Trimethoprim]]
* [[Trimethoprim]]
Line 411: Line 494:
* [[Venlafaxine]]
* [[Venlafaxine]]
* [[Verapamil]]
* [[Verapamil]]
* [[Verteporfin]]
* [[Vortioxetine]]
* [[Vortioxetine]]
* [[Zaleplon]]
* [[Zaleplon]]
* [[Zanamivir]]
* [[Zanamivir]]
* [[Ziconotide]]
* [[Zidovudine]]
* [[Zidovudine]]
* [[Ziv-aflibercept]]
* [[Zolmitriptan]]
* [[Zolmitriptan]]
* [[Zolpidem]]
* [[Zolpidem]]
Line 420: Line 506:


===Drugs Labelled as Category D===
===Drugs Labelled as Category D===
* [[Afatinib]]
* [[Aliskiren]]
* [[Aliskiren]]
* [[Alprazolam]]
* [[Alprazolam]]
* [[Altretamine]]
* [[Amiodarone]]
* [[Amiodarone]]
* [[Aminoglutethimide]]
* [[Amlodipine and Benazepril]]
* [[Amlodipine and Benazepril]]
* [[Amlodipine besylate and Valsartan]]
* [[Amlodipine besylate and Valsartan]]
* [[Arsenic trioxide]]
* [[Atenolol]]
* [[Atenolol]]
* [[Axitinib]]
* [[Azathioprine]]
* [[Azathioprine]]
* [[Azilsartan kamedoxomil]]
* [[Azilsartan kamedoxomil]]
* [[Azilsartan kamedoxomil and chlorthalidone]]
* [[Azilsartan kamedoxomil and chlorthalidone]]
* [[Belinostat]]
* [[Benazepril]]
* [[Benazepril]]
* [[Benazepril hydrochloride/Hydrochlorothiazide]]
* [[Benazepril hydrochloride/Hydrochlorothiazide]]
* [[Bendamustine]]
* [[Bendamustine]]
* [[Bortezomib]]
* [[Bortezomib]]
* [[Bosutinib]]
* [[Butabarbital]]
* [[Cabozantinib]]
* [[Candesartan]]
* [[Candesartan]]
* [[Capecitabine]]
* [[Capecitabine]]
* [[Captopril]]
* [[Captopril]]
* [[Carbamazepine]]
* [[Carbamazepine]]
* [[Carfilzomib]]
* [[Ceritinib]]
* [[Ciclopirox]]
* [[Cisplatin]]
* [[Cisplatin]]
* [[Clonazepam]]
* [[Clonazepam]]
* [[Cyclophosphamide]]
* [[Cyclophosphamide]]
* [[Cytarabine]]
* [[Cytarabine]]
* [[Cytarabine liposome]]
* [[Dasatinib]]
* [[Dasatinib]]
* [[Daunorubicin]]
* [[Dexrazoxane]]
* [[Divalproex]]
* [[Divalproex]]
* [[Doxycycline Hyclate]]
* [[Doxycycline Hyclate]]
Line 448: Line 549:
* [[Enalapril maleate]]
* [[Enalapril maleate]]
* [[Enalapril maleate/Hydrochlorothiazide]]
* [[Enalapril maleate/Hydrochlorothiazide]]
* [[Epirubicin]]
* [[Eprosartan]]
* [[Eprosartan]]
* [[Eprosartan]]
* [[Eprosartan]]
* [[Eribulin]]
* [[Erlotinib]]
* [[Erlotinib]]
* [[Everolimus]]
* [[Everolimus]]
* [[Floxuridine]]
* [[Fluconazole]] (for all other indications other than vaginal candidiasis)
* [[Fluconazole]] (for all other indications other than vaginal candidiasis)
* [[Fludarabine]]
* [[Fluorouracil]]
* [[Fosinopril]]
* [[Fosinopril]]
* [[Gemcitabine]]
* [[Gentamicin]]
* [[Gentamicin]]
* [[Hydroflumethiazide]]
* [[Hydroflumethiazide]]
*[[Hydroxyurea (patient information)]]
* [[Hydroxyurea (patient information)]]
* [[Ibrutinib]]
* [[Ibritumomab tiuxetan]]
* [[Idarubicin hydrochloride]]
* [[Irbesartan]]
* [[Irbesartan]]
* [[Ixabepilone]]
* [[Lapatinib]]
* [[Lisinopril/Hydrochlorothiazide]]
* [[Lisinopril/Hydrochlorothiazide]]
* [[Losartan]]
* [[Losartan]]
Line 467: Line 579:
* [[Moexipril/Hydrochlorothiazide]]
* [[Moexipril/Hydrochlorothiazide]]
* [[Minocycline hydrochloride]]
* [[Minocycline hydrochloride]]
* [[Mitoxantrone]]
* [[Nelarabine]]
* [[Nelarabine]]
* [[Nilotinib]]
* [[Olaparib]]
* [[Olmesartan]]
* [[Olmesartan]]
* [[Olmesartan Medoxomil-Hydrochlorothiazide]]
* [[Olmesartan Medoxomil-Hydrochlorothiazide]]
* [[Omacetaxine]]
* [[Pamidronic acid]]
* [[Paroxetine]]
* [[Paroxetine]]
* [[Pembrolizumab]]
* [[Pemetrexed]]
* [[Pemetrexed]]
* [[Perindopril]]
* [[Perindopril]]
* [[Phenobarbital]]
* [[Phenobarbital]]
* [[Potassium iodide]]
* [[Potassium iodide]]
* [[Procarbazine]]
* [[Quinapril]]
* [[Quinapril]]
* [[Quinapril/Hydrochlorothiazide]]
* [[Quinapril/Hydrochlorothiazide]]
* [[Ramipril]]
* [[Ramipril]]
* [[Samarium (153Sm) lexidronam]]
* [[Secobarbital sodium]]
* [[Secobarbital sodium]]
* [[Streptozocin]]
* [[Tamoxifen]]
* [[Tamoxifen]]
* [[Tetracycline]]
* [[Tetracycline]]
* [[Tigecycline]]
* [[Tigecycline]]
* [[Topiramate]]
* [[Topiramate]]
* [[Trametinib]]
* [[Trandolapril]]
* [[Trandolapril]]
* [[Trastuzumab]]
* [[Trastuzumab]]
Line 488: Line 610:
* [[Trimethoprim sulfamethoxazole]]
* [[Trimethoprim sulfamethoxazole]]
* [[Valsartan]]
* [[Valsartan]]
* [[Vinblastine]]
* [[Vismodegib]]
* [[Warfarin]]
* [[Warfarin]]
* [[Zoledronate]]


===Drugs Labelled as Category X===
===Drugs Labelled as Category X===
Line 494: Line 619:
* [[Anastrozole]]
* [[Anastrozole]]
* [[Atorvastatin calcium]]
* [[Atorvastatin calcium]]
* [[Bexarotene ]]
* [[Boceprevir]]
* [[Boceprevir]]
* [[Clomifene]]
* [[Clomifene]]
* [[Conjugated estrogens/bazedoxifene]]
* [[Danazol]]
* [[Danazol]]
* [[Degarelix]]
* [[Denosumab]]
* [[Denosumab]]
* [[Desogestrel/ethinyl estradiol and ethinyl estradiol]]
* [[Desogestrel/ethinyl estradiol and ethinyl estradiol]]
Line 502: Line 630:
* [[Dutasteride]]
* [[Dutasteride]]
* [[Dutasteride and Tamsulosin hydrochloride]]
* [[Dutasteride and Tamsulosin hydrochloride]]
* [[Enzalutamide]]
* [[Ezetimibe/Simvastatin]]
* [[Ezetimibe/Simvastatin]]
* [[Finasteride]]
* [[Finasteride]]
Line 537: Line 666:
* [[Thalidomide]]
* [[Thalidomide]]
* [[Triazolam]]
* [[Triazolam]]
* [[Urofollitropin]]


==Australia==
==Australia==

Latest revision as of 15:44, 17 April 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites that are present in breast milk.

United States

The United States Food and Drug Administration (FDA)-assigned pregnancy categories as used in the Drug Formulary are outlined as follows:

United States FDA Pharmaceutical Pregnancy Categories
Pregnancy Category A Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.
Pregnancy Category B Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
Pregnancy Category C Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category D 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 cannot be used or are ineffective).
Pregnancy Category X Studies in animals or human beings 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.

Drugs Labelled as Category A

Drugs Labelled as Category B

Drugs Labelled as Category C

Drugs Labelled as Category D

Drugs Labelled as Category X

Australia

The Australian Therapeutic Goods Administration (TGA) categorization system differs from the US FDA categorization:

  • The categorization of medicines for use in pregnancy does not follow a hierarchical structure.
  • Human data are lacking or inadequate for drugs in the B1, B2 and B3 categories.
  • Subcategorization of the B category is based on animal data.
  • The allocation of a B category does not imply greater safety than a C category.
  • Medicines in category D are not absolutely contraindicated during pregnancy (e.g.anticonvulsants).

The TGA-assigned pregnancy drug categories are outlined as follows:

ADEC Pregnancy Categories (Australia)
Pregnancy Category A Drugs which have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Pregnancy Category B1 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
Pregnancy Category B2 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Pregnancy Category B3 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Pregnancy Category C Drugs which, owing to their pharmaceutical effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible.
Pregnancy Category D Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
Pregnancy Category X Drugs that have such a high risk of causing permanent damage to the fetus that they should NOT be used in pregnancy or when there is a possibility of pregnancy.

Categorization of Selected Agents

The data presented is for comparative and illustrative purposes only, and may have been superseded by updated data.

Classification of some agents, based on different national bodies
Pharmaceutical agent Australia United States
Acetaminophen/Paracetamol A B
Amoxicillin A B
Amoxicillin with clavulanic acid B1 B
Isotretinoin X X
Phenytoin D D
Rifampicin C C
Thalidomide X X
Theophylline A C
Tetracycline D D

References

  1. Australian Therapeutic Goods Administration (TGA) categorization system