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Pregnancy Categories for Drugs

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Pregnancy Categories for Drugs

Each drug approved by the Federal Drug Administration (FDA) has a Pregnancy Category associated with it. These Categories indicate which drugs how safe a drug is to use during pregnancy. There are 5 FDA Pregnancy Categories:. Categories A, B, C, D, and X.

*Always consult your doctor before taking any medication.
Pregnancy 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).[1]
Pregnancy 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.[1]

Asacol Oral (Mesalamine) - Procter & Gamble Pharmaceuticals, Inc.[9]

Asacol HD Oral (Mesalamine) - Procter & Gamble Pharmaceuticals, Inc.[10]

Augmentin (Amoxicillin and Clavulante Potassium) - Physicians Total Care, Inc.[11]

Colazal (balsalazide disodium) - Oral - Salix Pharmaceuticals, Inc.[12]

Enbrel (Amgen)[13]

HUMIRA (adalimumab) - Abbott Laboratories[14]

Lialda (mesalamine) - Oral - Shire US Inc.[15]

Omnicef - Cefdinir (Antibiotic. Abbott Laboratories)[16]

Mesalamine Rectal Suspension USP 4g.60mL - TEVA PHARMACEUTICALS USA[17]

Metronidazole (Flagyl)[18]

Paracetamol (Acetaminophen), (APAP)[19][20]

PENTASA (mesalamine) - Oral - Shire US Inc.[21]

Sulfasalazine - Greenstone LLC[22][23] - Anti Inflammatory
*Reduces absorbption of folate.

Remicade (Infliximab) - Janssen Inc.[24][25][26][27]

Rowasa (Mesalamine)[28]
Pregnancy 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.[1]

Actemra (tocilizumab) - Genentech Roche [8][29][30][31]
Interleukin-6 (IL-6) receptor inhibitor indicated for treatment of Rheumatoid Arthritis


Asacol Oral (Mesalamine) - Cardinal Health[32]

Avelox

Budesonide Capsules (generic Entocort formulation)

Cipro (ciprofloxacin hydrochloride) - Bayer HealthCare, Schering-Plough[33][34]

Corticosteroids -

Creon - (Pancrelipase) - Abbott Laboratories Inc.[35]

Cyclosporin -

Entocort EC

Epogen - Amgen[36]

Fosamax (alendronate sodium) - Merck & Co.[37]

Loperamide hydrochloride capsules - Anti diarrheal - Teva Pharmaceuticals USA[38]

Lyrica (pregabalin) - Pregnancy Category C - Pfizer[39]

Moxifloxacin

Naltrexone[40][41]

Neulasta (Amgen)[42]

Neupogen (Amgen)[43]

Nplate (romiplostim) (Amgen)[44]

Olsalazine

Prolia (denosumab) Amgen[45]

ReVia (Naltrexone hydrochloride) - Oral - Barr Laboratories Inc.[46][47]

Rifaximin - (please see Xifaxan, below)

Sensipar (cinacalcet) Amgen[48]

Simethicone[49]

Tacrolimus -

Tocilizumab (Actemra) - Genentech Roche[8]

Ultram (Tramadol) - Janssen[50]

Vectibix (panitumumab) Amgen[51]

Xeljanz (Tofacitinib) Pfizer[52]

Xifaxan - (Rifaximin) Salix Pharmaceuticals, Inc.[53]
Pregnancy 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.[1]

Azathioprine (Imuran)[5]

Xgeva (denosumab) Amgen Initial U.S. Approval: 2010 [6]
Pregnancy 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.[1]

Accutane (isotretinoin) - Roche[54]

Arava [7] -

Leflunomide [7] -

Methotrexate -
*Reproduction is not advised for female or male patients during treatment with Methotrexate or for 6 months after Methotrexate treatment is stopped.[55]

Thalidomide -

Vytorin (ezetimibe / simvastatin) - Merck & Co., Inc.[56]

References

[pos]1a[/pos][1]. http://depts.washington.edu/druginfo.../Pregnancy.pdf

[pos]2a[/pos][2]. http://www.gpo.gov/fdsys/pkg/FR-2008...f/E8-11806.pdf

[pos]3a[/pos][3]. Paracetamol (Acetaminophen), (APAP) http://www.otispregnancy.org/files/acetaminophen.pdf

[pos]4a[/pos][4]. Habal FM and Ravindran NC. Management of inflammatory bowel disease in the pregnant patient. World J Gastroenterol. 2008; 14(9):13261332. http://www.ncbi.nlm.nih.gov/pmc/arti...JG-14-1326.pdf

[pos]5a[/pos][5]. Azathioprine tablet. Roxane Laboratories, Inc. Updated June 2011. Accessed September 2012. From http://dailymed.nlm.nih.gov Azathioprine Link

[pos]6a[/pos][6]. Xgeva (denosumab) prescribing information. Amgen. Accessed September 2012. http://pi.amgen.com/united_states/xgeva/xgeva_pi.pdf

[pos]7a[/pos][7]. Arava (leflunomide). Sanofi-Aventis U.S. LLC. http://www.arava.com/hcp/default.aspx

[pos]8a[/pos][8]. Actemra (tocilizumab) Injection for intravenous infusion. 2012 Genentech, Inc. Updated October 2012; Accessed December 2012. http://www.actemra.com and http://www.gene.com/gene/products/in...mra/pdf/pi.pdf

[pos]9a[/pos][9]. http://dailymed.nlm.nih.gov/dailymed...4-06e651d004d2

[pos]10a[/pos][10]. http://dailymed.nlm.nih.gov/dailymed...0-fb99044c14f0

[pos]11a[/pos][11]. http://dailymed.nlm.nih.gov/dailymed...0-ea3039786480

[pos]12a[/pos][12]. http://dailymed.nlm.nih.gov/dailymed...9-65e077abd787

[pos]13a[/pos][13]. http://pi.amgen.com/united_states/en.../enbrel_pi.pdf

[pos]14a[/pos][14]. http://dailymed.nlm.nih.gov/dailymed...a-7159aa5f933d

[pos]15a[/pos][15]. http://dailymed.nlm.nih.gov/dailymed...8-7fc4beab77b7

[pos]16a[/pos][16]. http://www.rxabbott.com/pdf/omnicef.pdf

[pos]17a[/pos][17]. http://dailymed.nlm.nih.gov/dailymed...e-f88c2aefa470

[pos]18a[/pos][18]. http://labeling.pfizer.com/ShowLabeling.aspx?id=570

[pos]19a[/pos][19]. http://www.otispregnancy.org/files/acetaminophen.pdf

[pos]20a[/pos][20]. http://www.tylenolprofessional.com/assets/TYL_PPI.pdf

[pos]21a[/pos][21]. http://dailymed.nlm.nih.gov/dailymed...5-159e03e2daba

[pos]22a[/pos][22]. http://dailymed.nlm.nih.gov/dailymed...o.cfm?id=17307

[pos]23a[/pos][23]. http://www.drugs.com/pro/sulfasalazi...e-tablets.html

[pos]24a[/pos][24]. http://www.remicade.com/hcp/remicade/assets/hcp_ppi.pdf

[pos]25a[/pos][25]. http://www.accessdata.fda.gov/drugsa...72s5295lbl.pdf

[pos]26a[/pos][26]. http://www.fda.gov/downloads/Drugs/D.../ucm107718.pdf

[pos]27a[/pos][27]. http://www.drugs.com/remicade.html

[pos]28a[/pos][28]. http://www.Rowasa.com

[pos]29a[/pos][29]. http://www.gene.com/gene/products/in...mra/pdf/pi.pdf

[pos]30a[/pos][30]. http://www.rochecanada.com/fmfiles/r...raJan19CIE.pdf

[pos]31a[/pos][31]. http://www.gene.com/gene/products/in...mra/pdf/pi.pdf

[pos]32a[/pos][32]. http://dailymed.nlm.nih.gov/dailymed...b-821b08115109

[pos]33a[/pos][33]. http://www.accessdata.fda.gov/drugsa...1473s24lbl.pdf

[pos]34a[/pos][34]. http://www.bayer.ca/files/CIPRO-PM-E...012-150473.pdf

[pos]35a[/pos][35]. http://www.rxabbott.com/pdf/creon_PI.pdf

[pos]36a[/pos][36]. http://pi.amgen.com/united_states/ep...cp_english.pdf

[pos]37a[/pos][37]. http://www.merck.com/product/usa/pi_...fosamax_pi.pdf

[pos]38a[/pos][38]. http://dailymed.nlm.nih.gov/dailymed...2-32ac979ff963

[pos]39a[/pos][39]. http://labeling.pfizer.com/ShowLabeling.aspx?id=561

[pos]40a[/pos][40]. http://www.drugs.com/pro/naltrexone.html

[pos]41a[/pos][41]. http://www.accessdata.fda.gov/drugsa...897s015lbl.pdf

[pos]42a[/pos][42]. http://pi.amgen.com/united_states/ne...cp_english.pdf

[pos]43a[/pos][43]. http://pi.amgen.com/united_states/ne...cp_english.pdf

[pos]44a[/pos][44]. http://pi.amgen.com/united_states/np...cp_english.pdf

[pos]45a[/pos][45]. http://pi.amgen.com/united_states/prolia/prolia_pi.pdf

[pos]46a[/pos][46]. http://dailymed.nlm.nih.gov/dailymed...1-852ea3521707

[pos]47a[/pos][47]. http://www.mims.com/USA/drug/info/na...gnancyCategory

[pos]48a[/pos][48]. http://pi.amgen.com/united_states/se...cp_english.pdf

[pos]49a[/pos][49]. https://online.epocrates.com/u/10a2166/simethicone

[pos]50a[/pos][50]. http://www.ultram-er.com/sites/defau...s/ultramer.pdf

[pos]51a[/pos][51]. http://pi.amgen.com/united_states/ve...ectibix_pi.pdf

[pos]52a[/pos][52]. http://labeling.pfizer.com/ShowLabeling.aspx?id=959

[pos]53a[/pos][53]. http://www.salix.com/assets/pdf/pres.../xifaxanpi.pdf

[pos]54a[/pos][54]. http://www.accessdata.fda.gov/drugsa...662s060lbl.pdf

[pos]55a[/pos][55]. http://www.ncbi.nlm.nih.gov/pmc/arti...JG-14-1326.pdf

[pos]56a[/pos][56]. http://www.accessdata.fda.gov/drugsa...687s044lbl.pdf

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