"Black Box" Warnings Joseph A

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University of the Pacific Scholarly Commons School of Pharmacy and Health Sciences Faculty Thomas J. Long School of Pharmacy and Health Articles Sciences

3-1-2006 Products with "Black Box" Warnings Joseph A. Woelfel University of the Pacific, [email protected]

Follow this and additional works at: https://scholarlycommons.pacific.edu/phs-facarticles Part of the Pharmacy and Pharmaceutical Sciences Commons

Recommended Citation Woelfel, J. A. (2006). Products with "Black Box" Warnings. Pharmacist’s Letter & Prescriber’s Letter, 22(3), 1–6. https://scholarlycommons.pacific.edu/phs-facarticles/41

This Article is brought to you for free and open access by the Thomas J. Long School of Pharmacy and Health Sciences at Scholarly Commons. It has been accepted for inclusion in School of Pharmacy and Health Sciences Faculty Articles by an authorized administrator of Scholarly Commons. For more information, please contact [email protected]. Detail-Document #220332 −This Detail-Document accompanies the related article published in− PHARMACIST’S LETTER / PRESCRIBER’S LETTER March 2006 ~ Volume 22 ~ Number 220332

Products with “Black Box” Warnings (Last modified March 2017) * For a list of Drugs with Medication Guides, please go to Detail-Document #220331 *

Abacavir / Lamivudine ( Epzicom ) Alvimopan ( Entereg ) Antidepressants (Aplenzin , Forfivo XL, Abacavir Sulfate (Ziagen ) Ambrisentan ( Letairis ) Luvox, Prozac, Symbyax , Wellbutrin , and Abacavir/Dolutegravir/Lamivudine ( Triumeq ) Amiloride ( Midamor ) Zyban listed separately) Abacavir/Lamivudine/Zidovudine ( Trizivir ) Amino acid/electrolyte/dextrose/lipid injectable ( Kabiven ) Links to Examples: Abarelix ( Plenaxis ) Aminoglycosides, Parenteral Brisdelle (paroxetine) Acetaminophen-containing products, oral Link to Example: Cymbalta (duloxetine) (prescription only) Tobramycin Emsam (selegiline) Link to Examples: Amiodarone ( Cordarone ) Fetzima (levomilnacipran) Fioricet w/ Codeine Amphetamines and Amphetamine Mixtures Marplan (isocarboxazid) Ultracet Links to Examples: Viibryd (vilazodone) Acetaminophen Injection ( Ofirmev ) Adderall XR Anti-inhibitor Coagulant Complex ( Feiba Acetylcysteine Inhalation ( Mucomyst ) Desoxyn VH ) Acitretin ( Soriatane ) Dexedrine Antipsychotics, Atypical (aripiprazole, Adalimumab ( Humira ) Dyanavel XR clozapine, Latuda , Rexulti , Seroquel , Adalimumab-atto ( Amjevita ) Amphotericin B ( Fungizone ) Symbyax , and Zyprexa Relprevv listed Adefovir Dipivoxil (Hepsera ) Anabolic Steroids separately) and Conventional (Adasuve Ado-trastuzumab ( Kadcyla ) Link to Example: listed separately) Albiglutide ( Tanzeum ) Anadrol-50 (oxymetholone) Links to Examples: Aldesleukin ( Proleukin ) Angiotensin II Receptor Blockers (ARBs) Risperdal , Alemtuzumab ( Campath , Lemtrada ) Link to Examples: Risperdal Consta (risperidone) Alglucosidase alfa ( Myozyme, Lumizyme ) Avalide, Avapro (irbesartan) Haloperidol Aliskiren ( Tekturna, Tekturna HCT ) Azor (amlodipine/olmesartan) Vraylar (cariprazine) Aliskiren/Amlodipine ( Tekamlo ) Diovan, Diovan HCT (valsartan) Zyprexa (olanzapine) Aliskiren/Amlodipine/HCTZ ( Amturnide ) Edarbi (azilsartan) Anti-thymocyte Globulin, rabbit Aliskiren/Valsartan ( Valturna ) Entresto (sacubitril/valsartan) (Thymoglobulin ) Allergen extract, grass pollen (Grastek ) Angiotensin-converting Enzyme Inhibitors (ACEIs) Anti-thymocyte Globulin Allergen extract, grass pollens ( Oralair ) Link to Example: (equine)/lymphocyte immune globulin Allergen extract, ragweed pollen ( Ragwitek ) Aceon (perindopril erbumine) (Atgam) Alosetron HCl ( Lotronex ) Mavik (trandolapril) Apixaban ( Eliquis ) Alprostadil ( Prostin VR Pediatric ) Prestalia (perindopril/amlodipine) Aprotinin ( Trasylol ) Altretamine ( Hexalen ) Anthrax Immune Globulin ( Anthrasil ) Arformoterol ( Brovana ) More. . . Copyright © 2006 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com More Products with “Black Box” Warnings (Detail -Document #220332: Page 2 of 7)

Aripiprazole ( Abilify , Abilify Maintena , Aristada ) Bupropion/Naltrexone ( Contrave ) Danazol Arsenic Trioxide ( Trisenox ) Busulfan ( Busulfex [inj.], Myleran [oral]) Dantrolene ( Dantrium ) Atomoxetine ( Strattera ) Cabazitaxel ( Jevtana ) Darbepoetin alfa ( Aranesp ) Atracurium ( Tracrium ) Cabozantinib ( Cometriq ) Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir Aurothioglucose ( Solganal ) (Product Capecitabine ( Xeloda ) (Viekira Pak , Viekira XR ) discontinued) Capreomycin ( Capastat ) Daunorubicin, liposomal (DaunoXome ) Azathioprine ( Imuran ) Carbamazepine ( Carbatrol , Carnexiv , Equetro , Tegretol ) Daunorubicin, conventional ( Cerubidine ) Bacitracin Injection ( Baci-IM ) Carbidopa ( Lodosyn ) Deferasirox ( Exjade , Jadenu ) Baclofen Intrathecal ( Lioresal , Gablofen ) Carboplatin ( Paraplatin ) Deferiprone ( Ferriprox ) Basiliximab ( Simulect ) Carmustine ( BiCNU ) Denileukin Diftitox ( Ontak ) BCG Live ( TICE BCG ) Certolizumab ( Cimzia ) Desirudin ( Iprivask ) Becaplermin ( Regranex ) Cetuximab ( Erbitux ) Desmopressin nasal spray ( Noctiva ) Bedaquiline ( Sirturo ) Chlorambucil ( Leukeran ) Dexmethylphenidate ( Focalin , Focalin XR ) Belatacept ( Nulojix ) Chloramphenicol ( Chloroptic ) Diatrizoate Meglumine (Crystografin , Benzodiazepine products Chlorhexidine gluconate ( ChloraPrep Tint ) others) Link to Examples: Chloroquine ( Aralen ) Diatrizoate/Iodipamide Meglumine Ativan (lorazepam) Cidofovir ( Vistide ) (Sinografin ) Restoril (temazepam) Cilostazol ( Pletal ) Diatrizoate Meglumine/Sodium Xanax (alprazolam) Cisapride ( Propulsid ) (Gastrografin ) Beta-Blockers (Sotalol listed separately) Cisplatin ( Platinol ) Diclofenac Gel ( Solaraze ) Link to Example: Cladribine ( Leustatin ) Didanosine ( Videx , Videx EC ) Toprol-XL (metoprolol) Clindamycin ( Cleocin ) Dihydrocodeine [plus aspirin, caffeine] Bevacizumab ( Avastin ) Clonidine Injection ( Duraclon ) (Synalgos-DC ) Bexarotene, oral ( Targretin ) Clopidogrel ( Plavix ) Dinoprostone Products Bleomycin ( Blenoxane ) Clozapine ( Clozaril, FazaClo , Versacloz ) Link to Example: Blinatumomab ( Blincyto ) Codeine-containing products Cervidil Bosentan ( Tracleer ) Link to Examples: Dinutuximab ( Unituxin ) Botulinum Toxin ( Botox , Botox Cosmetic , Codeine tablets Disopyramide ( Norpace ) Dysport , Myobloc ) Tuxarin ER (codeine/chlorpheniramine) Disulfiram ( Antabuse ) Brentuximab ( Adcetris ) Corticosteroids, Inhaled Diuretics, Loop Bretylium Tosylate (Product discontinued) Link to Example: Link to Example: Brexpiprazole ( Rexulti ) Pulmicort (budesonide) Bumex (bumetanide) Brodalumab ( Siliq ) Cyclosporine ( Sandimmune, Neoral ) Docetaxel ( Taxotere , Docefrez ) Budesonide Inhalation ( Pulmicort ) Cytarabine, liposomal (DepoCyt ) Dofetilide ( Tikosyn ) Bupivacaine ( Marcaine , Sensorcaine ) Cytarabine, conventional Dopamine ( Intropin ) Buprenorphine Buccal Film ( Belbuca ) Dabigatran ( Pradaxa ) Doxorubicin Liposome Injection ( Doxil ) Buprenorphine Implant ( Probuphine ) Dacarbazine ( DTIC-Dome ) Doxorubicin, conventional ( Adriamycin ) Buprenorphine Transdermal ( Butrans ) Daclatasvir ( Daklinza ) Dronedarone ( Multaq ) Bupropion ( Aplenzin , Forfivo XL, Daclizumab ( Zenapax , Zinbryta ) Droperidol ( Inapsine ) Wellbutrin , Zyban ) Dactinomycin ( Cosmegen ) Droxidopa ( Northera )

More. . . Copyright © 2006 by Therapeutic Research Center Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.pharmacistsletter.com ~ www.prescribersletter.com More Products with “Black Box” Warnings (Detail -Document #220332: Page 3 of 7)

Dulaglutide ( Trulicity ) Exenatide Extended-release ( Bydureon ) Ridaura (auranofin) Ecallantide ( Kalbitor ) Ezogabine ( Potiga ) Gold Sodium Thiomalate Products Eculizumab ( Soliris ) Felbamate ( Felbatol ) Link to example: Edetate Disodium ( Endrate ) Fentanyl Buccal Film ( Onsolis ) Myochrisine Edoxaban ( Savaysa ) Fentanyl Citrate ( Actiq , Fentora ) Golimumab ( Simponi , Simponi Aria ) Efalizumab ( Raptiva ) Fentanyl Iontophoretic Transdermal ( Ionsys ) Hemin ( Panhematin ) Efavirenz/Emtricitabine/Tenofovir ( Atripla ) Fentanyl Nasal Spray ( Lazanda ) Human Chorionic Gonadotropin Elbasvir/Grazoprevir ( Zepatier ) Fentanyl Sublingual Spray ( Subsys ) Products Elosulfase alfa ( Vimizim ) Fentanyl Sublingual Tablet (Abstral ) Link to example: Eltrombopag ( Promacta) Fentanyl Transdermal ( Duragesic ) Pregnyl Emtricitabine ( Emtriva ) Ferumoxytol ( Feraheme ) Hydralazine/Hydrochlorothiazide Emtricitabine/Tenofovir alafenamide ( Descovy ) Flecainide ( Tambocor ) Hydrocodone ER (Hysingla ER , Emtricitabine/Tenofovir disoproxil (Truvada ) Flibanserin ( Addyi ) Vantrela ER , Zohydro ER ) Emtricitabine/Rilpivirine/Tenofovir alafenamide Floxuridine Hydrocodone-containing antitussives : (Odefsey) Flucytosine ( Ancobon ) Link to examples: Emtricitabine/Rilpivirine/Tenofovir disoproxil Fludarabine ( Fludara ) Obredon (Complera ) Flumazenil ( Romazicon ) Rezira Emtricitabine/Elvitegravir/Cobicistat/Tenofovir Fluoroquinolone Antibiotics (systemic only) Tussionex disoproxil fumarate (Stribild ) Link to example: Hydrocodone/Ibuprofen ( Vicoprofen ) Emtricitabine/Elvitegravir/Cobicistat/Tenofovir Avelox (moxifloxacin) Hydromorphone Injection (Dilaudid-HP ), alafenamide ( Genvoya ) Cipro (ciprofloxacin) Oral ( Dilaudid , Exalgo , Palladone ) Entecavir ( Baraclude ) Levaquin (levofloxacin) Hydroxyethyl Starch Solutions ( Hespan , Epirubicin Injection ( Ellence ) Fluorouracil ( Efudex ) Hextend , Epoetin alfa ( Epogen , Procrit ) Fluoxetine (Prozac , Prozac Weekly ) Voluven ) Ergotamine Derivatives Flutamide ( Eulexin ) Hydroxyurea ( Droxia ) Link to Example: Fluvoxamine ( Luvox ) Ibritumomab Tiuxetan ( Zevalin ) Migranal (dihydroergotamine) Fondaparinux ( Arixtra ) Ibutilide Fumarate ( Corvert ) Erythromycin Estolate (Product discontinued) Formoterol Products Icodextrin ( Extraneal ) Estradiol Transdermal Spray ( Evamist ) Links to examples: Idarubicin ( Idamycin PFS ) Estrogens with and without Progestins (Duavee , Bevespi , Dulera, Foradil , Symbicort Idelalisib ( Zydelig ) Evamist , and NuvaRing listed separately) Foscarnet ( Foscavir ) Idursulfase ( Elaprase ) Links to Examples: Fosphenytoin ( Cerebyx ) Ifosfamide (Ifex ) Angeliq , Elestrin , Femhrt , Gadolinium-based contrast agents Iloperidone ( Fanapt ) Premarin Vaginal Cream , Prempro (Ablavar, Dotarem , Eovist , Gadavist, Magnevist , MultiHance, Immune Globulins (human, equine, rabbit) Estrogen/Bazedoxifene ( Duavee ) Omniscan , OptiMARK , ProHance, Vasovist ) Link to example: Etanercept (Enbrel ) Gallium Nitrate ( Ganite ) Gamunex (Immune Globulin Human) Etanercept-szzs ( Erelzi ) Ganciclovir (Cytovene IV, Cytovene oral) Immune Globulin Rh o(D) (WinRho SDF ) Ethinyl Estradiol/Etonogestrel Vaginal Ring Gemtuzumab ( Mylotarg ) Immune Globulin with hyaluronidase (NuvaRing ) Gold Compounds (Hyqvia ) Everolimus ( Zortress ) Link to example: IncobotulinumtoxinA ( Xeomin )

Indacaterol ( Arcapta Neohaler ) Leflunomide ( Arava ) Methoxsalen, topical ( Oxsoralen ) Indacaterol/glycopyrrolate ( Utibron Neohaler ) Lenalidomide ( Revlimid ) Methoxy polyethylene glycol-epoetin beta Infliximab ( Remicade ) Lesinurad ( Zurampic ) (Mircera ) Infliximab-dyyb ( Inflectra ) Lidocaine viscous 2% Methyldopa/Hydrochlorothiazide Insulin inhalation ( Afrezza ) Linaclotide ( Linzess ) Methylphenidate Products Interferon Alfa-2b, Recombinant Inj (Intron A) Lincomycin ( Lincocin ) Link to examples: Interferon alfacon-1 Injection (Infergen ) Lindane Aptensio XR Intravenous Fat Emulsion Products Liraglutide ( Victoza , Saxenda ) Ritalin LA Link to example: Liraglutide/Insulin Degludec ( Xultophy ) Daytrana Liposyn Lisdexamfetamine ( Vyvanse ) Quillichew ER Smoflipid Lithium Carbonate or Citrate Products Quillivant XR Iodixanol ( Visipaque ) Link to Example: Metoclopramide Products Iohexol ( Omnipaque ) Lithobid Link to example: Iopamidol ( Isovue ) Lomitapide ( Juxtapid ) Metozolv ODT Iopromide ( Ultravist ) Lomustine ( CeeNU ) Reglan ODT Ioversol ( Optiray ) Low Molecular Weight Heparins (LMWH) Metolazone ( Mykrox , Zaroxolyn ) Ipilimumab ( Yervoy ) Link to Example: Metreleptin ( Myalept ) Irinotecan ( Camptosar ) Lovenox (enoxaparin) Metronidazole ( Flagyl ) Irinotecan Liposome ( Onivyde ) Loxapine ( Adasuve ) Metronidazole/tetracycline/bismuth Iron Dextran Injection ( INFed, DexFerrum ) Lurasidone ( Latuda ) (Pylera ) Iron-containing Products (Oral) Macitentan ( Opsumit ) Mexiletine Link to example: Mannitol for Inhalation ( Aridol ) Midazolam ( Versed ) Ferralet (carbonyl iron) Maraviroc ( Selzentry ) Midodrine ( Orvaten , ProAmatine ) Isoniazid-containing drugs (Isoniazid, Rifater , Mechlorethamine HCl for Injection ( Mustargen ) Mifepristone ( Korlym , Mifeprex ) Rifamate ) Medroxyprogesterone ( Depo -Provera Contraceptive Injection ) Milnacipran ( Savella ) Isotretinoin-containing products Mefloquine ( Lariam ) Miltefosine ( Impavido ) Link to example: Melphalan ( Alkeran ) Minoxidil ( Loniten , Rogaine ) Absorica Mercaptopurine ( Purinethol ) Mipomersen ( Kynamro ) Itraconazole ( Sporanox) Metformin ( Glucophage ) and combination products Misoprostol ( Cytotec ) Ixabepilone ( Ixempra ) Methacholine ( Provocholine ) Misoprostol/Diclofenac ( Arthrotec ) Ketamine ( Ketalar ) Methadone Injection Mitomycin ( Mutamycin ) Ketoconazole ( Nizoral ) Methadone Oral (Dolophine ) Mitotane ( Lysodren ) Ketorolac Tablets, Injection Methohexital ( Brevital ) Mitoxantrone for Injection ( Novantrone ) Ketorolac Nasal Spray ( Sprix ) Methotrexate Sodium for Injection Modafinil ( Provigil ) Lamivudine (Epivir, Epivir-HBV) Methotrexate SQ ( Otrexup , Rasuvo ) Moricizine ( Ethmozine ) Lamivudine/Raltegravir ( Dutrebis ) Methotrexate Products (Oral) Morphine Extended-release ( Arymo ER , Lamivudine/Zidovudine ( Combivir ) Link to example: Avinza , Kadian , Morphabond , MS Contin ) Lamotrigine ( Lamictal, Lamictal ODT, XR ) Rheumatrex Morphine inj preservative-free ( Duramorph ) Lapatinib ( Tykerb ) Methoxsalen, extracorporeal ( Uvadex) Morphine/Naltrexone ( Embeda ) Laronidase ( Aldurazyme ) Methoxsalen, oral (8-MOP,Oxsoralen -Ultra) Muromonab-CD3 ( Orthoclone OKT3 )

Mycophenolate ( CellCept ) Oxaliplatin ( Eloxatin ) Pioglitazone-containing products (Actos , Mycophenolic Acid ( Myfortic ) Oxycodone ( Oxaydo , OxyContin , Roxicodone , Xtampza ER ) Actoplus Met, Actoplus Met XR, Duetact , Natalizumab ( Tysabri ) Oxycodone Oral Solution Oseni ) Necitumumab ( Portrazza ) Oxycodone/acetaminophen ( Xartemis XR ) Plecanatide ( Trulance ) Nelarabine ( Arranon ) Oxycodone/aspirin ( Percodan ) Podophyllotoxin Derivatives (etoposide, Neomycin Oral Oxycodone/naloxone ( Targiniq ER ) teniposide) Nevirapine ( Viramune ) Oxycodone/naltrexone ( Troxyca ER ) Polymyxin B Injection Nilotinib ( Tasigna ) Oxymorphone ( Opana ER ) Polysaccharide Iron Complex ( Niferex ) Nilutamide ( Nilandron ) Oxytocin ( Pitocin ) Pomalidomide ( Pomalyst ) Nimodipine ( Nimotop ) Paclitaxel Ponatinib ( Iclusig ) Nitroprusside Sodium ( Nitropress ) Paclitaxel Albumin-bound ( Abraxane ) Pooled plasma SD (solvent detergent) Non-steroidal Anti-inflammatory Drugs Pancuronium treated (NSAIDs) (Arthrotec , Ketorolac, Solaraze , and Panitumumab ( Vectibix ) (Plas+SD ) Vicoprofen listed separately) Panobinostat ( Farydak ) Pramlintide ( Symlin ) Link to Examples: Parathyroid hormone ( Natpara ) Prasugrel ( Effient ) Caldolor (ibuprofen injectable) Pazopanib ( Votrient ) Primaquine Duexis (ibuprofen/famotidine) Peginesatide ( Omontys ) Procainamide ( Pronestyl ) Dyloject (diclofenac injection) Peginterferon Alfa-2a ( Pegasys ) Procarbazine ( Matulane ) Pennsaid (diclofenac topical) Peginterferon Alfa-2b ( PegIntron , Sylatron ) Progesterone ( Prometrium ) Vimovo (naproxen/esomeprazole) Pegloticase ( Krystexxa ) Promethazine, oral/suppository (Phenergan ) Vivlodex (meloxicam) Pemoline ( Cylert ) Promethazine, injectable Norelgestromin/Ethinyl Estradiol Patch ( Ortho Penicillamine ( Cuprimine ) Promethazine/codeine oral solution (also see Evra ) Penicillin G Benzathine ( Bicillin L-A) “codeine-containing products) Norepinephrine Bitartrate ( Levophed ) Penicillin G benzathine/penicillin G procaine Propafenone ( Rythmol SR ) Obiltoxaximab ( Anthim ) (Bicillin C-R) Propoxyphene ( Darvocet , Darvon. etc) Obinutuzumab ( Gazyva ) Pentazocine Combinations Propylthiouracil Ofatumumab ( Arzerra ) Link to Example: Protamine Sulfate Olanzapine ER injection ( Zyprexa Relprevv ) Talwin Nx Quetiapine ( Seroquel , Seroquel XR ) Olanzapine/Fluoxetine ( Symbyax ) Pentostatin ( Nipent ) Quinidine Olodaterol ( Striverdi Respimat ) Perampanel ( Fycompa ) Quinine ( Qualaquin ) Olodaterol/tiotropium ( Stiolto Respimat ) Perflutren Lipid Microsphere Contrast Agent Raloxifene ( Evista ) Omalizumab ( Xolair ) (Definity ) Ramucirumab ( Cyramza ) Ombitasvir/Paritaprevir/Ritonavir ( Technivie ) Perflutren Protein-Type A Microsphere Contrast Agent (Optison ) Rasburicase ( Elitek ) Oprelvekin ( Neumega ) Pertuzumab ( Perjeta ) Regorafenib ( Stivarga ) Oral Contraceptives Phentermine ( Adipex-P, others) Reslizumab ( Cinqair ) Links to Examples: Phenylephrine Injection ( Neo-Synephrine ) Ribavirin ( Copegus, Rebetol, Ribasphere, Ortho-Novum /Modicon (norethindrone/ethinyl Phenytoin Injection ( Dilantin ) Virazole) estradiol) Phytonadione Injection ( AquaMephyton ) Ribavirin/Interferon Alfa-2b ( Rebetron ) Yaz (drospirenone/ethinyl estradiol) Pimavanserin ( Nuplazid ) Riociguat ( Adempas ) Ospemifene ( Osphena ) Pimecrolimus Cream (Elidel ) Ritonavir ( Norvir )

Rituximab ( Rituxan ) Telaprevir ( Incivek ) Triamterene ( Dyrenium ) Rivaroxaban ( Xarelto ) Telavancin ( Vibativ ) Valganciclovir ( Valcyte ) Rocuronium ( Zemuron ) Telbivudine ( Tyzeka ) Valproic Acid, Divalproex Products Rosiglitazone-containing products (Avandia , Telithromycin ( Ketek ) Link to Examples: Avandamet , Avandaryl ) Tenofovir Disoproxil Fumarate (Viread ) Depacon Rubidium Rb 82 ( CardioGen-82 ) Tenofovir Alafenamide ( Vemlidy ) Depakene Salicylates Terbutaline (oral, injection) Depakote Link to Example: Teriflunomide ( Aubagio ) Stavzor Aspirin Teriparatide (rDNA origin) Injection Vandetanib (Caprelsa ) Salmeterol (Forteo ) Vecuronium Links to Examples: Testosterone Gel ( AndroGel 1%, 1.62%; Testim , Fortesta , Vogelxo ) Vigabatrin ( Sabril ) Advair Diskus , Airduo Respiclick , Serevent Testosterone Topical Solution ( Axiron ) Vilanterol/Fluticasone ( Breo Ellipta ) Diskus Testosterone Undecanoate Injection ( Aveed ) Vilanterol/Umeclidinium ( Anoro Ellipta ) Simeprevir ( Olysio ) Tetrabenazine ( Xenazine ) Vinblastine Sirolimus ( Rapamune ) Thalidomide ( Thalomid ) Vincristine Smallpox (Vaccinia) Vaccine ( ACAM2000 ) Thiotepa ( Tepadina ) Vincristine Liposome ( Marqibo ) Sodium Nitrite/Thiosulfate ( Nithiodote ) Thrombin Topical (Evithrom , Recothrom , Vinorelbine (Navelbine ) Sodium Oxybate ( Xyrem ) Thrombin-JMI ) Vismodegib ( Erivedge ) Sodium Phosphate, Oral ( Visicol , Thyroid Hormones Vorapaxar ( Zontivity ) OsmoPrep ) Links to Example: Warfarin ( Coumadin ) Sofosbuvir ( Sovaldi ) Liothyronine ( Cytomel ) Zalcitabine ( Hivid ) Sofosbuvir/Ledipasvir ( Harvoni ) Ticagrelor ( Brilinta ) Ziconotide ( Prialt ) Sofosbuvir/Velpatasvir (Epclusa ) Ticlopidine ( Ticlid ) Zidovudine (Retrovir oral, IV) Sonidegib ( Odomzo ) Tigecycline ( Tygacil ) Ziv-aflibercept ( Zaltrap ) Sotalol ( Betapace , Sotylize ) Tinidazole ( Tindamax ) Spironolactone ( Aldactone ) Tipranavir ( Aptivus ) Spironolactone/HCTZ ( Aldactazide ) Tizanidine ( Zanaflex ) Stavudine ( Zerit ) Tocilizumab ( Actemra ) Streptomycin Tofacitinib ( Xeljanz , Xeljanz XR ) Streptozocin ( Zanosar ) Tolcapone ( Tasmar ) Succinylcholine ( Anectine , Quelicin ) Tolvaptan ( Samsca ) Sulfur hexafluoride lipid-type A microspheres Topotecan ( Hycamtin ) (Lumason ) Toremifene ( Fareston ) Sunitinib ( Sutent ) Tositumomab/Iodine I 131 Tositumomab Tacrolimus Extended-Release ( Astagraf XL , (Bexxar ) Envarsus XR ) Tramadol-containing products Tacrolimus Injectable/Oral ( Prograf ) Link to Example: Tacrolimus Ointment (Protopic ) Ultram Tamoxifen Trastuzumab ( Herceptin ) Tapentadol ER (Nucynta ER ) Tretinoin ( Vesanoid)

Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and Internet links in this article were current as of the date of publication.

Cite this Detail-Document as follows: Products with “black box” warnings. Pharmacist’s Letter/Prescriber’s Letter 2006;22(3):220332.

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