Boxed Warnings Flashcards
Abacavir
Hypersensitivity (HLA B*5701),
APAP
risk of med errors
hepatotoxicity
Fluoroquinolones
e.g. moxifloxacin, levofloxacin, ciprofloxacin
“Serious adverse reactions”:
- Risk of tendonitis and tendon rupture
- peripheral neuropathy
- CNS effects
Exacerbation of myasthenia gravis
Aminoglycosides
e.g. tobramycin, gentamicin
Ototoxicity
nephrotoxicity
ACE Inhibitors and ARBs
Fetal Toxicity
Beta Blockers
metoprolol, atenolol
“Ischemic heart disease”: abrupt discontinuation can result in exacerbations of angina pectoris, even MI. Gradually taper off.
Calcineurin inhibitors (topical)
maybe malignancy
Calcineurin Inhibitors
malignancies and serious infection
mortality in liver transplantation
Loop Diuretics
furosemide, bumetanide
Volume and electrolyte depletion
Estrogen
breast cancer
endometrial cancer (unopposed estrogens)
cardiovascular disease: MI, stroke, VTE
use lowest effective dosage for shortest amount of time
increased risk of dementia
NSAIDs
serious CV thrombotic events: MI, stroke
serious GI events: bleeding, ulcerations, perforation
Oral contraceptives
> 35 + cigarette smoking (contraindication)
SSRIs
Increased risk of suicidal thinking and behavior in children, adolescents and young adults
Antipsychotics
atypical and typical
Increased mortality in elderly patients with dementia-related psychosis
Amiodarone
life-threatening arrhythmias
worsened arrhythmias (initiate in a clinical setting)
pulmonary toxicity
hepatotoxicity
Atomoxetine
suicidal ideation in children and adolescents
Clozapine
Severe neutropenia: baseline ANC must be >1500, need ANC monitoring. Agranulocytosis
seizures; dose-related
myocarditis, cardiomyopathy and mitral valve incompetence
orthostatic hypotension, bradycardia, syncope
Increased mortality in elderly pts w/dementia related psychosis
Fentanyl
Duragesic: do NOT expose to heat
Life threatening respiratory depression
addiction, abuse, misuse
accidental exposure
CYP4503A4 interactions
Neonatal Opioid withdrawal syndrome
Risks w/concomitant BZDs or CNS depressants
Risk of med errors
Opioids
Addiction, abuse, misuse
Benefits outweigh risks
Life threatening respiratory depression
accidental ingestion
neonatal opioid withdrawal
CYP3A4 interactions
Risks from concomitant BZDs and CNS depressants
Risk of med errors
ketoconazole
appropriate use
hepatotoxicity
QT prolongation
Methadone
all opioid BWs
Life threatening QT prolongation
Thiazolidinediones
congestive heart failure: can cause or exacerbate
Selective Estrogen Receptor Modulators (SERMs)
Increased risk of VTE
Cardiovascular disease: increased risk of death d/t stroke
LABAs
e.g. salmeterol
asthma-related death (as monotherapy for asthma, need ICS too)