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Black Box Warnings

Please review each of these drugs carefully.

abacavir	Hypersensitivity
acetaminophen	Hepatotoxicity
acetaminophen-butalbital-caffeine	Hepatotoxicity
acetaminophen-codeine	acetaminophen: Hepatotoxicity codeine in children: death due to ultra-rapid metabolism
acetaminophen-diphenhydrAMINE	Hepatotoxicity
acetaminophen-HYDROcodone	Hepatotoxicity
acetaminophen-oxyCODONE	acetaminophen: hepatotoxicity oxyCODONE oral solution: risk of errors Addition, Abuse, and Misuse; Life-Threatening Depression; Accidental Exposure; Neonatal Opioid Withdrawal Syndrome; and Hepatotoxicity
acetaminophen-traMADol	Hepatotoxicity
acetylcysteine	Inhalation solution: not for injection
adalimumab	Infection risk; malignancy in children and adolescents
aldesleukin	Capillary Leak Syndrome
alemtuzumab	Hematological toxicity; opportunistic infections
aliskiren	Pregnancy risk
alogliptin-metFORMIN	metFORMIN: Lactic Acidosis
alvimopan	Short-term hospital use only
amikacin	Neurotoxicity; nephrotoxicity
aMILoride	Hyperkalemia
amiodarone	Oral: Pneumonitis; Proarrhythmic Effects
amitriptyline	Suicidal ideation in children, adolescents
amphetamine-dextroamphetamine	Abuse/diversion potential; drug dependence
amphotericin B	Noninvasive fungal disease; avoid overdose
amphotericin B lipid complex	Lipid Emulsions: Death in preterm infants
apixaban	Discontinuation without anticoagulation
arformoterol	Asthma Related Death
ARIPiprazole	Elderly patients with dementia related psychosis
arsenic trioxide	Cardiac toxicity
asparaginase Escherichia coli	Anaphylaxis; sudden death
atenolol	Avoid abrupt withdrawal
bacitracin	Injection: Nephrotoxicity
baclofen	Intrathecal: Abrupt discontinuation
becaplermin topical	Increased risk of secondary malignancy
benazepril	ACE inhibitor pregnancy risk
benzathine penicillin-procaine penicillin	Not for Intravenous Use
bevacizumab	GI perforation; wound healing complications
bleomycin	Pulmonary Fibrosis; Idiosyncratic Reactions
budesonide-formoterol	Asthma Related Death
bumetanide	Potent diuretic
bupivacaine	Intravascular injection risk; 0.75% strength caution
bupivacaine-EPINEPHrine	Bupivacaine: Intravascular injection risk; 0.75% strength caution
bupivacaine-fentaNYL	bupivacaine: Intravascular injection risk; 0.75% strength caution
buPROPion	Suicidal Ideation
cabazitaxel	Hemtalogical & Hypersensitivity Reactions
caffeine-ergotamine	Drug interaction risk
canagliflozin	Lower Limb Amputation
candesartan	Pregnancy risk
capecitabine	Warfarin Interaction
captopril	Pregnancy risk
captopril-hydroCHLOROthiazide	captopril: Pregnancy risk
carBAMazepine	Hematological Risk; Serious Dermatologic Reactions
carbidopa-levodopa	Bolded (not boxed): Carbidopa dosing
CARBOplatin	Myelosuppression; Anaphylaxis risk
carmustine	Bone Marrow Suppression; Pulmonary Toxicity
celecoxib	Cardiovascular, gastrointestinal risk
cetuximab	Infusion Reactions; Cardiopulmonary Arrest
chloramphenicol	Fatal blood dyscrasias
chlorproMAZINE	Mortality in elderly with dementia
cidofovir	Nephrotoxicity; neutropenia
cilostazol	CHF patient contraindication
ciprofloxacin	Tendinitis; tendon rupture
CISplatin	Nephrotoxicity; Myelosuppression
citalopram	Suicidal Thoughts and Behaviors
clindamycin	Pseudomembranous colitis
cloNIDine	Epidural cloNIDine
clopidogrel	Poor CYP2C19 metabolizers
cloZAPine	Agranulocytosis, myocarditis, seizure risk
codeine	codeine in children: death due to ultra-rapid metabolism
conjugated estrogens IV	Endometrial cancer; cardiovascular; dementia risk
conjugated estrogens topical	Endometrial cancer; cardiovascular; dementia risk
cycloSPORINE	Infection, neoplasm, nephrotoxicity risk
cycloSPORINE IV	Infection, neoplasm, nephrotoxicity risk
cytarabine	Prior to initiation of therapy
dabigatran	Discontinuation without anticoagulation
dacarbazine	Hemopoietic depression; hepatic necrosis risk
DACTINomycin	Handling precautions; extravasation risk
dalfopristin-quinupristin	Approved indication
danazol	Pregnancy contraindication; stroke risk; hepatic risk with long term use; benign intracranial hypertension
dantrolene	Hepatitis risk
darbepoetin alfa	Mortality, serious CV events, tumor progression or recurrence
demo	Cardiovascular; gastrointestinal risk
denosumab	Severe Hypocalcemia in Patients with Advanced Kidney Disease
desvenlafaxine	Suicidal ideation
diatrizoate	Not for intrathecal use
diclofenac	Cardiovascular, gastrointestinal risk
didanosine	Pancreatitis, hepatotoxicity, lactic acidosis risk
dihydroergotamine	Drug interaction risk
disopyramide	Mortality Risk
DOCEtaxel	Hepatic dysfunction, hypersensitivity risk
dofetilide	Initiation or re-initiation monitoring
DOPamine	Peripheral ischemia risk
doxepin	Suicidal Ideation
DOXOrubicin	Cardiac, hepatic, myelosuppression, extravasation risk
DOXOrubicin liposomal	Cardiac, acute infusion reaction, myelosuppresssion risk
dronedarone	Contraindication in certain CHF conditions
DULoxetine	Suicidal Ideation
edetate calcium disodium	Lead encephalopathy risk
emtricitabine	Lactic Acidosis, Severe Hepatomegaly
emtricitabine-tenofovir	Emtricitabine: Lactic acidosis, severe hepatomegaly; hepB co-infection Tenofovir: lactic acidosis, severe hepatomegaly; hepB co-infection Lactic Acidosis; severe hepatomegaly; hep B co-infection
enalapril	Pregnancy risk
enoxaparin	Spinal/epidural hematoma risk
epiRUBicin	Myocardial toxicity; extravasation
epoetin alfa	Risk of mortality, tumor progression, cardiac events
escitalopram	Suicidal ideation
esterified estrogens	Endometrial cancer; cardiovascular; dementia risk
estradiol patch	Transdermal: endometrial cancer; cardiovascular; dementia risk Vaginal cream/tab: endometrial cancer; cardiovascular; dementia risk
estradiol vaginal	Endometrial cancer; cardiovascular; dementia risk Vaginal cream/tab: endometrial cancer; cardiovascular; dementia risk
ethacrynic acid	Potent Diuretic
ethinyl estradiol-norethindrone	Cigarette smoking; risk of cardiovascular disease
etodolac	Cardiovascular; gastrointestinal risk
etoposide	Myelosuppression risk
exenatide	Extended Release Injection: Risk of thyroid c-cell tumors
factor VIIa, recombinant	Serious Thrombotic Adverse Events Associated with Recombinant Coagulation Factor VIIa Outside Label Indicatons
fat emulsion, intravenous	Cautious use in infants
fentaNYL	Buccal Tablet: Serious adverse events, deaths; abuse potential Nasal Spray: Schedule II Controlled Substance: Abuse potential Sublingual Spray: Risk of respiratory depression, medication errors, abuse potential Transdermal: High concentration of Schedule II opioid agonist
ferric carboxymaltose	Iron Overdose Risk
ferrous fumarate	Iron Overdose Risk
ferrous gluconate	Iron Overdose Risk
ferrous sulfate	Iron Overdose Risk
ferumoxytol	Iron Overdose Risk
flecainide	Cardiovascular risk
floxuridine	Hematological risk
flucytosine	Hepatic, hematologic risks; caution in renal impairment
fludarabine	Neurotoxicity, hemolytic anemia risk
flumazenil	Seizure Risk
FLUoxetine	Suicidal Ideation
FLUoxetine-OLANZapine	FLUoxetine: Suicidal ideation OLANZapine:Mortality in elderly with dementia related psychosis Sucidal Thoughts and Behaviors; Increased Mortality in Elderly Patients with Dementia-Related Psychosis
fluPHENAZine	Mortality in elderly with dementia
fluticasone-salmeterol	Salmeterol: asthma related death; pediatric and adolescent patients
fluticasone-umeclidinium-vilanterol	Asthma Related Death
fluvoxaMINE	Suicidal Ideation
fondaparinux	Spinal/epidural hematoma risk
formoterol	Asthma Related Death
foscarnet	Nephrotoxicity; seizure risk
fosinopril	Pregnancy risk
fosphenytoin	Cardiovascular risk with rapid infusion
furosemide	Potent Diuretic
ganciclovir	Hematological toxicity; IV and oral different indications
gentamicin	Ototoxicity; Nephrotoxocity
glyBURIDE-metFORMIN	Lactic Acidosis
glycopyrrolate-indacaterol	Asthma-related death
golimumab	Risk of Serious Infections, Malignancy in Children and Adolescents
haloperidol	Mortality in elderly with dementia
hemin	Use only after alternate therapy failure
heparin	Spinal/Epidural Hematomas
hydroCHLOROthiazide-losartan	Angiotensin II antagonist pregnancy risk
hydroCHLOROthiazide-methyldopa	Individualize dose
hydroCHLOROthiazide-spironolactone	Possible tumorigen
hydroCHLOROthiazide-triamterene	Hyperkalemia
hydroCHLOROthiazide-valsartan	Valsartan: ACE inhibitor pregnancy risk
HYDROmorphone	Injection: Respiratory depression risk; abuse potentia Injection, High Potency: Opioid-tolerant patients only; Respiratory depression risk; abuse potential Oral, extended release: Opioid-tolerant patients only; overdose risk; abuse potential Oral, liquid & tablets: Abuse potential; respiratory depression; neonatal withdrawal; alcohol interaction
hydroxychloroquine	Prior to initiation of therapy
hydroxyurea	Prior to initiation of therapy
ibuprofen	Cardiovascular; gastrointestinal risk
ibutilide	Potentially Fatal Arrhythmias
ifosfamide	Urotoxicity; myelosuppressionm CNS toxicity
imipramine	Suicidal ideation
immune globulin intramuscular	Renal dysfunction, acute renal failure
immune globulin intravenous	Renal dysfunction, acute renal failure
immune globulin intravenous and subcutaneous	Renal dysfunction, acute renal failure
indacaterol	Asthma Related Death
indomethacin	Cardiovascular; gastrointestinal risk
inFLIXimab	Serious infection risk; hepatosplenic t-cell lymphomas; malignancy
insulin aspart	Risk of acute bronchospasm in patients with chronic lung disease
insulin aspart-insulin aspart protamine	Risk of acute bronchospasm in patients with chronic lung disease
insulin human in Normal Saline	Risk of acute bronchospasm in patients with chronic lung disease
insulin isophane (NPH)	Risk of acute bronchospasm in patients with chronic lung disease
insulin isophane-insulin regular	Risk of acute bronchospasm in patients with chronic lung disease
insulin regular	Risk of acute bronchospasm in patients with chronic lung disease
interferon alfa-2b	Neuropsychiatric, autoimmune, ischemic and infectious disorders
ipilimumab	Immune-Mediated Adverse Reactions
irbesartan	ACE inhibitor pregnancy risk
irinotecan	Severe diarrhea
iron dextran	Injection: Anaphylactic reaction risk
iron polysaccharide	Iron overdose risk
iron sucrose	Iron overdose risk
ixabepilone	Toxicity in hepatic impariment
ketamine	Emergence reactions; psychological manifestations
ketoprofen	Cardiovascular; gastrointestinal risk
ketorolac	Duration of therapy; max dose; GI, cardiovascular, bleeding, renal risk
lamiVUDine	Lactic acidosis, hepatomegaly; exacerbations of hepatitis b; dosing formulation
lamiVUDine-zidovudine	lamiVUDine: Lactic acidosis, hepatomegaly; exacerbations of hepatitis b; dosing formulation Zidovudine: Hematological adverse events; myopathy; lactic acidosis; hepatomegaly
lamoTRIgine	Serious dermatological reactions
lapatinib	Hepatotoxicity
leflunomide	Pregnancy risk
levoFLOXacin	Tendinitis, tendon rupture
levonorgestrel	Bolded (not boxed): Not Protective Against HIV
levothyroxine	Treatment of obesity or weight loss
lidocaine topical	Lidocaine, viscous: Do NOT use for teething pain
lindane topical	Neurotoxicity
liothyronine	Treatment of obesity or weight loss
lisinopril	ACE inhibitor pregnancy risk
lithium	Monitoring recommendations
lopinavir-ritonavir	ritonavir: Drug interactions
losartan	Pregnancy risk
loxapine	Elderly patients with dementia related psychosis Aerosol: Bronchospasm
mannitol	Severe bronchospasm risk
medroxyPROGESTERone	Cardiovascular and other risks
medroxyPROGESTERone IM	Cardiovascular and other risks
meloxicam	Cardiovascular; gastrointestinal risk
melphalan	Bone marrow suppression; hypersensitivity reactions; pregnancy risk
mercaptopurine	Bolded (not boxed): initiation of therapy
metFORMIN	Lactic Acidosis
metFORMIN-pioglitazone	metFORMIN: Lactic Acidosis Congestive heart failure
metFORMIN-rosiglitazone	metFORMIN: Lactic Acidosis
metFORMIN-SAXagliptin	metFORMIN: Lactic Acidosis
metFORMIN-SITagliptin	metFORMIN: Lactic Acidosis
methacholine	Diagnostic use only
methadone	Risk during initiation of or conversion to methadone
methohexital	Continuous monitoring of respiratory and cardiac function
methotrexate	Bone marrow, liver, lung and kidney toxicity risk
methotrexate IV	Bone marrow, liver, lung and kidney toxicity risk
methylphenidate	Tolerance and dependence
metoclopramide	Tardive Dyskinesia
metOLazone	Bolded (not boxed): do not interchange
metroNIDAZOLE	Carcinogenicity
mexiletine	Mortality; Acute Liver Injury
midazolam	Individualize dose
midodrine	Supine blood pressure > 180 mmHg
minoxidil	Antihypertensive risk
mirtazapine	Suicidal ideation
miSOPROStol	Pregnancy risk
mitoMYcin	Bone marrow suppression; hemolytic uremic syndrome
mitoXANTRONE	Cardiotoxicity; baseline neutrophil count; extravasation risk
moexipril	ACE inhibitor pregnancy risk
morphine	24-hour observation following epidural/intrathecal administration
moxifloxacin	Tendinitis, tendon rupture
multivitamin with iron	Iron overdose risk
mycophenolate mofetil	Prior to initiation of therapy
mycophenolate mofetil IV	Prior to initiation of therapy
nabumetone	Cardiovascular; gastrointestinal risk
nadolol	Avoid abrupt withdrawal
naloxone-pentazocine	Oral use only
naltrexone	Abuse Liability
naproxen	Cardiovascular; gastrointestinal risk
nefazodone	Hepatotoxicity
neomycin	Neurotoxicity, nephrotoxicity, ototoxicity; general toxicity
nevirapine	Hepatotoxicity; dermal reactions; patient monitoring
niMODipine	Serious harm with IV administration of oral product
nitroprusside	Cyanide toxicity; hypotension risk; dilute
norEPINEPHrine	Extravasation risk
norethindrone	Cigarette smoking; risk of cardiovascular disease
nortriptyline	Suicidal ideation
OLANZapine	Mortality in elderly with dementia related psychosis
olmesartan	ACE inhibitor pregnancy risk
olodaterol	Olodaterol: Asthma-Related Death
olodaterol-tiotropium	Olodaterol: Asthma-Related Death
omalizumab	Anaphylaxis
onabotulinumtoxinA	Distant spread of toxin effect
oprelvekin	Allergic reactions, including anaphylaxis
OXALIplatin	Anaphylactic-like reactions
oxyCODONE	Oral solution: Risk of errors Controlled release: Abuse potential
oxyMORphone	Abuse/diversion potential; drug dependence
oxytocin	Elective induction of labor
PACLitaxel	Prior to initiation of therapy
PACLitaxel protein-bound	Prior to initiation of therapy
PARoxetine	Suicidal ideation
pegloticase	Anaphylaxis and Infusion Reactions
pentostatin	Prior to initiation of therapy
perflutren	Serious cardiopulmonary reactions
perindopril	ACE inhibitor pregnancy risk
pertuzumab	Cardiomyopathy and Embryo-Fetal Toxicity
phenylephrine	Prior to initiation of therapy
phenytoin IV	Cardiovascular risk with rapid infusion
phytonadione	Severe reactions with IV use
pioglitazone	Congestive heart failure
piroxicam	Cardiovascular; gastrointestinal risk
prasugrel	Bleeding risk
primaquine	Prior to initiation of therapy
procainamide	Positive titers with chronic administration
procarbazine	Prior to initiation of therapy
prochlorperazine	Elderly patients with dementia related psychosis
progesterone	Cardiovascular disorders; breast cancer; probable dementia
promethazine	Patients < 2 years; severe tissue injury
propafenone	Mortality (CAST trial results)
propranolol	Avoid abrupt withdrawal
propylthiouracil	Severe liver injury; acute liver failure
protamine	Hypotension, pulmonary hypertension; risk factors described
prothrombin complex	Arterial and venous thromboembolic complications
QUEtiapine	Elderly patients with dementia related psychosis
quinapril	ACE inhibitor pregnancy risk
quiNINE	No benefit in leg cramps; hematologic risks
ramipril	Olmesartan: ACE inhibitor pregnancy risk
rasburicase	Anaphylaxis; hemolysis; methemoglobinemia; uric acid measure interference
risperiDONE	Elderly patients with dementia related psychosis
ritonavir	Drug interaction risk
riTUXimab	Fatal infusion reaction; mucocutaneous reactions; progressive multifocal leukoencephalopathy; hep b reactivation
rivaroxaban	Premature discontinuation; spinal/epidural hematomas
rocuronium	Prior to initiation of therapy
rosiglitazone	Thiazolidinediones, including pioglitazone and rosiglitazone, cause or exacerbate congestive heart failure in some patients.
sacubitril-valsartan	valsartan: ACE inhibitor pregnancy risk
salmeterol	Asthma Related Deaths
salsalate	Cardiovascular; gastrointestinal risk
sertraline	Suicidal ideation
sodium phosphate	Phosphate nephropathy
sotalol	Therapy initiation; renal impairment caution; product selection
spironolactone	Possible tumorigen
stavudine	Pancreatitis, lactic acidosis, hepatomegaly
streptomycin	Neurotoxicity; nephrotoxicity
streptozocin	Nephrotoxicity; experienced physician; mutagen
succinylcholine	Hyperkalemic rhabdomyolysis in infants or children
sulindac	Cardiovascular; gastrointestinal risk
SUNItinib	Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe and deaths have been reported.
tacrolimus	Lymphoma risk; infection related to immunosuppression
tamoxifen	Women at high risk for breast cancer; women with DCIS
telmisartan	ACE inhibitor pregnancy risk
tenofovir	Lactic acidosis, severe hepatomegaly; hepB co-infection
terbutaline	Preterm labor (injectable and oral)
testosterone	Secondary exposure to testosterone Testosterone undecanoate, injection: POME reactions and anaphylaxis
thalidomide	Teratogen; informed consent required
thioridazine	QTc prolongation; elderly with dementia related psychosis
thiothixene	Elderly patients with dementia related psychosis
thrombin topical	Bleeding, thrombosis risk
thyroid desiccated	Treatment of obesity or weight loss
ticagrelor	Bleeding Risk
ticlopidine	Severe hematological adverse events
tigecycline	All cause mortality
timolol	Avoid abrupt withdrawal
tiZANidine	Bolded (not boxed): bioequivalence between products
tobramycin	Ototoxicity, nephrotoxicity risk with IV use
tocilizumab	Serious infections risk
tolcapone	Hepatotoxicity
topotecan	Bone marrow suppression
trastuzumab	Cardiomyopathy; infusion reactions, pulmonary toxicity; teratogenicity
traZODone	Suicidal ideation
trifluoperazine	Elderly patients with dementia related psychosis
umeclidinium-vilanterol	Asthma Related Death
valGANciclovir	Granulocytopenia, Anemia, Thrombocytopenia
valproic acid IV	Risk to children exposed in utero
valproic acid PO	Risk to children exposed in utero
valsartan	ACE inhibitor pregnancy risk
varenicline	Serious neuropsychiatric events, monitoring and patient counseling
venlafaxine	Suicidal ideation
vilazodone	Suicidal ideation
vinBLAStine	IV use only; granulocytopenia; avoid extravasation
vinCRIStine	IV use only; dose liposomal product differently
vinORELBine	IV use only; granulocytopenia; avoid extravasation
warfarin	Serious bleeding risk
zidovudine	Hematological adverse events; myopathy; lactic acidosis; hepatomegaly
ziprasidone IM	Mortality in elderly with dementia related psychosis
ziprasidone PO	Mortality in elderly with dementia related psychosis
ziv-aflibercept	Gastrointestinal hemorrhage and perforation; Compromised wound healing
zolpidem	Complex Sleep Behaviors

Pharmacy Contact Info:

Main Inpatient Pharmacy: ext 4599, 3503
Fax: 704-878-7283

Director of Pharmacy - Randi Raynor, PharmD: ext 4501
Clinical Coordinator - Laura Rollings, PharmD: ext 4597
Pharmacy Informaticist - Stephen Pringle, PharmD: ext 7645
Pharmacy Technician Supervisor - Amy Wingler, CPhT: ext 7385
Pharmacy Automation Coordinator (Omnicell) - Melissa Fulford, CPhT: ext 3556

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as to the use of this information outside of Iredell Memorial Hospital.
The content of this policy and procedure document serves as guidance to the delivery of quality patient care.
Care providers are expected to exercise critical thinking and situational awareness skills,
and in specific situations to take such action as is necessary for the delivery of quality patient care.