Monday, June 15, 2015

Common REMS Drugs


Drug or Class
Safety Concerns
Apixaban 
Thrombotic events - stroke, in patients with nonvalvular atrial fibrillation when stopping without introducing an adequate alternative anticoagulant
Ambrisentan 
Adverse fetal outcomes
belatacept
Post-transplant lymphoproliferative disorder (PTLD)
Bosentan 
Hepatotoxicity, teratogenic effects
Buprenorphine 
Abuse potential
Buproprion 
Serious risks
Clozapine 
Neutropenia, aplastic anemia
Darbepoetin 
Cardiovascular events, stroke, increased mortality, tumor progression
Dofetilide 
Ventricular Arrhythmia
Dronedarone 
Prevent use in symptomatic heart failure and atrial fibrillation 
Epoetin alpha
Cardiovascular events, stroke, increased mortality, tumor progression
Fentanyl 
Abuse potential 
Fingolimid 
Bradyarrhythmia and atrioventricular block at treatment initiation,
Infections, macular edema, respiratory effects, hepatic effects, and fetal risk
Hydromorphone 
Overdose with abuse
Isotretinoin 
Teratogenic - iPLEDGE
Letairis
Hepatotoxicity, teratogenic effects
Liraglutide 
Medullary thyroid carcinoma and the risk of acute pancreatitis
Metoclopramide 
Tardive dyskinesia
Mifepristone 
Use in inappropriate clinical situations
Morphine
Abuse potential 
Mycophenolate
To avoid in pregnancy
Naltrexone 
Use in appropriate clinical situations
Natalizumab 
Progressive multifocal leukoencephalopathy (PML) - TOUCH
Olanzapine 
Post-injection delirium/ sedation syndrome 
Oxycodone 
Overdose 
Rosiglitazone 
Myocardial infarction
Tapentadol 
Overdose
Testosterone
Serious risks 
Thalidomide 
Teratogenic 
Tofacitinib 
Serious infections
Varenicline 
Neuropsychiatric symptoms
Vigabatrin 
Irreversible vision loss
Source:
http://dig.pharm.uic.edu/faq/restrictedaccess.aspx
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
http://www.ashp.org/REMS

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