4 Questions
In what scenarios is a boxed warning issued for a drug?
All of the above
What does REMS stand for?
Risk Evaluation and Mitigation Strategy
What specific condition must be met for Loxapine with an active REMS program? Risk of ________.
bronchospasm
Match the medication with the associated risk of adverse effect:
Buprenorphine = Risk of serious death or harm with IV administration; risk of abuse/overdose Clozapine = Risk of severe neutropenia Sodium oxybate = Risk of CNS depression and abuse/misuse Phentermine/topiramate = Risk of embryo-fetal toxicity Vigabatrin = Risk of vision loss
Study Notes
FDA Guidance on Boxed Warnings
- A boxed warning is issued in three scenarios: serious adverse reaction proportionate to potential benefit, preventable/reducible serious adverse reaction, and FDA-approved drug with restricted use.
- Boxed warnings consider patient selection, careful monitoring, avoiding concomitant therapy, and managing patients in a specific manner.
FDA Guidance on REMS Programs
- REMS (Risk Evaluation and Mitigation Strategy) programs are determined by the FDA for specific drugs.
- REMS programs can require: Medication Guides, communication plans, safe disposal technologies, and Elements To Assure Safe Use (ETASU).
Elements To Assure Safe Use (ETASU)
- Healthcare providers must have particular training/experience.
- Pharmacies/practitioners/healthcare settings must be specially certified.
- Drugs can only be dispensed in certain healthcare settings or with evidence of safe use conditions (e.g., lab results).
- Patients must be subject to monitoring or enrolled in a registry.
Medications with an Active REMS Program
- As of 4/17/24, there are 69 medications with REMS programs.
REMS – Neuro/Psych/Pain/Substance Abuse Medications
- Loxapine: risk of bronchospasm.
- Buprenorphine: risk of serious death or harm with IV administration and risk of abuse/overdose.
- Clozapine: risk of severe neutropenia.
- Sodium oxybate: risk of CNS depression and abuse/misuse.
- Opioid Analgesics: risk of abuse/misuse (ensures provider and patient education).
- Phentermine/topiramate: risk of embryo-fetal toxicity.
- Esketamine: risk of sedation/dissociation (must be administered by a healthcare provider).
- Vigabatrin: risk of vision loss.
- Olanzapine (Zyprexa Relprevv): risk of post-injection sedation/delirium syndrome.
REMS – Cardiovascular Medications
- Endothelin Receptor Antagonists: risk of embryo-fetal toxicity and hepatotoxicity (bosentan only).
- Mavacamten: risk of heart failure due to systolic dysfunction.
- Riociguat: risk of embryo-fetal toxicity.
REMS – Immunological Medications
- Alemtuzumab: risk of autoimmunity, infusion reactions, and malignancy.
- Thalidomide/lenalidomide: risk of embryo-fetal toxicity.
- Mycophenolate: risk of embryo-fetal toxicity.
- Brodalumab: risk of suicidal ideation.
- Eculizumab: risk of meningococcal infection.
- Natalizumab: risk of progressive multifocal leukoencephalopathy (PML).
REMS – Miscellaneous Medications
- Alvimopan: ensuring short-term use only.
This quiz covers FDA guidance on boxed warnings, scenarios for issuing boxed warnings, and REMS programs. It is a part of the NAPLEX review.
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