Table 1.
Examples of drugs with complex REMS (containing ETASU) classified by risk concern
| Medication (by brand name) | Risk/reason for REMS | |
|---|---|---|
| Addiction | Abstral (fentanyl sublingual tablets) | Abuse, misuse, overdose, and addiction |
| Butrans (buprenorphine transdermal system) | Abuse, misuse, overdose, and addiction | |
| Exalgo (hydromorphone hydrochloride) | Abuse, misuse, overdose and addiction | |
| Onsolis (fentanyl buccal soluble film) | Overdose, abuse, addiction, and serious complications due to medication errors | |
| OxyContin (oxycodone hydrochloride controlled-release) | Abuse, misuse, overdose, and addiction | |
| Suboxone (buprenorphine and naloxone) | Abuse, misuse, overdose, and addiction | |
| Xyrem (sodium oxybate, GHB) | Abuse, misuse, overdose, and addiction, along with serious CNS effects including respiratory depression | |
| Fetal exposure | Accutane (isotretinoin) | Adverse fetal outcomes |
| Letairis (ambrisentan) | Adverse fetal outcomes | |
| Revlimid (lenalidomide) and Thalomid (thalidomide) | Adverse fetal outcomes | |
| Cardiac | Avandia family [Avandia, Avandamet, Avandaryl] (rosiglitazone) | Myocardial infarction |
| Tikosyn (dofetilide) | Risk of induced arrhythmia | |
| GI | Lotronex (alosetron hydrochloride) | Ischemic colitis and complications of constipation |
| Infection/allergic reaction | Lumizyme (alglucosidase alfa) | Life-threatening or severe allergic reactions and severe skin and systemic immune-mediated reactions |
| Soliris (eculizumab) | Meningococcal infection (Neisseria meningitidis), other serious infections, and possible serious hemolysis post-discontinuation | |
| Hematological | Mifeprex (mifepristone) | Excessive bleeding |
| Nplate (romiplostim) | Changes in bone marrow reticulin formation and bone marrow fibrosis, worsened thrombocytopenia after cessation, thrombotic/thromboembolic complications, hematological malignancies, and progression of malignancy in patients with a preexisting hematological malignancy or myelodysplastic syndrome (MDS), and medication errors associated with serious outcomes | |
| CNS | Sabril (vigabatrin) | Vision loss and increased risk of suicidal thoughts and behavior |
| Zyprexa Relprevv (olanzapine) | Post-injection delirium/sedation syndrome (PDSS) | |
| Cancer | Erythropoiesis-stimulating agents (ESA): Aranesp (darbepoetin alfa); Epogen and Procrit (epoetin alfa) | Risk of shortened overall survival and/or increased risk of tumor progression or recurrence (also increased risk of death from cardiovascular and thromboembolic reactions) |
| Other | Extraneal (icodextrin) | Drug-device interaction and the potential for falsely elevated blood glucose readings |