|
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
