REMS stands for Risk Evaluation and Mitigation Strategies. These are special safety programs required by the FDA for certain medications that carry specific risks. If you’ve ever been prescribed a medication like isotretinoin, Prolia, or Spravato (esketamine), you may have already encountered REMS.
You can think of REMS as your safety net. It’s a system designed to help you safely access treatments that could truly change your life.
Quick Facts About REMS
- What it is: FDA-required safety programs for certain controlled-substance prescriptions
- Why it exists: To ensure the benefits of the drug outweigh its risks
- Who it involves: Patients, prescribers, pharmacies, and manufacturers
- Examples: Spravato, isotretinoin (iPLEDGE), Prolia
- How it helps: Encourages safe prescribing, administration, and monitoring
If you’re considering ketamine therapy, Spravato, or other advanced mental health treatments, it’s worth understanding how REMS ensures you’re getting the safest care possible.
Why Spravato Has a REMS Program
Spravato (esketamine) is FDA-approved for treatment-resistant depression and major depressive disorder with suicidal ideation. Because of how it works in the brain, it comes with a few risks that are important to monitor in the first couple hours after dosing.
Why REMS Applies to Spravato
The FDA requires Spravato to be administered under a REMS program because of the following manageable side effects:
- Sedation and dissociation: Some patients may feel drowsy or disconnected after taking Spravato
- Temporary blood pressure increases: A short-lived rise in blood pressure is common
- Potential for misuse: As a ketamine derivative, esketamine needs controlled access
To address these, the REMS framework ensures:
- Spravato is only available at certified clinics
- Patients are monitored for at least two hours after each session
- Medication cannot be taken home
This built-in structure is what makes Spravato both safe and effective. When used as intended, under medical supervision, most patients tolerate the treatment well and experience significant improvement in symptoms.
What Are the Goals of a REMS Program?
Not every medication needs a REMS program. The FDA only requires one if there are serious risks that need extra attention beyond the usual drug labeling. The goal is to make sure the benefits of treatment outweigh the risks.
REMS programs don’t cover every possible side effect. They focus on specific concerns that need active prevention or monitoring, such as sedation, organ damage, or risks during pregnancy. These safety plans are structured to reinforce safe-use behaviors by:
- Educating both providers and patients
- Mandating monitoring protocols
- Regulating how a drug is prescribed or dispensed
In practice, this could mean anything from requiring a certified clinic to perform blood tests, to simply providing a medication guide with every dose.
How REMS Works: A Team Effort
REMS programs involve everyone who touches your treatment plan:
- Patients: You may need to sign consent forms, follow certain monitoring instructions, or schedule treatments at specific certified facilities.
- Healthcare providers: Must complete training and become certified to prescribe certain REMS drugs, like Spravato.
- Pharmacies: Must be certified and follow procedures to ensure safety before dispensing medication.
- Drug manufacturers: They design, maintain, and fund the REMS, and report outcomes to the FDA.
At clinics like Anew Therapy Utah, a REMS-certified facility, the REMS process is woven into your care plan. It’s designed to run smoothly in the background so you can focus on healing.
Common REMS Medications
Spravato (esketamine)
Spravato’s REMS program requires in-office administration and two hours of observation. That may sound intensive, but it’s part of what makes the treatment safe and accessible. Most patients feel reassured knowing they’re being carefully monitored throughout the process.
Learn more about how Anew administers Spravato here: Spravato treatment info
iPLEDGE (isotretinoin)
iPLEDGE is the REMS program for isotretinoin, a powerful medication used to treat severe, cystic acne that hasn’t responded to other treatments. While highly effective, isotretinoin carries an extremely high risk of causing birth defects if taken during pregnancy. That’s why the iPLEDGE program requires patients who can become pregnant to use two forms of birth control, undergo monthly pregnancy tests, and complete regular check-ins before each refill. These steps are designed to prevent fetal exposure and ensure the medication is used as safely as possible.
Prolia (denosumab)
Prolia is a medication used to treat osteoporosis in postmenopausal women and others at high risk for bone fractures. The FDA requires a REMS program for Prolia because it can cause severe hypocalcemia (low blood calcium levels), especially in patients with advanced kidney disease. The REMS ensures healthcare providers monitor calcium levels closely and educate patients on the importance of calcium and vitamin D supplementation to prevent serious complications.
The Evolution of REMS Programs
REMS isn’t a static system. These programs are constantly being updated as new research, safety data, and patient experiences shape best practices. The FDA can revise or even eliminate a REMS program if the risks can be managed with standard prescribing.
One recent example: the Clozapine REMS was officially discontinued in June 2025. After reviewing years of safety data, the FDA found that standard labeling was sufficient and that REMS requirements were creating unnecessary delays.
In other words, REMS are not forever. They evolve alongside medicine.
Anew Therapy: Utah’s REMS Certified Clinic
At Anew Therapy in Utah, patient safety and access go hand in hand. As a REMS certified clinic, we’re fully equipped to administer advanced treatments like Spravato with the oversight required by the FDA. That means all treatments happen on site, under the supervision of trained professionals, with built-in time for observation and support.
From the moment you walk in, our team is focused on making the process feel smooth and stress-free. We handle the paperwork, insurance authorizations, and all REMS compliance steps behind the scenes, so you can focus on healing. Our clinic combines the structure of medical safety with a soothing, spa-like environment, so you can feel truly at ease while you receive treatment.
If you have questions about your eligibility or want to learn more about what Spravato treatment looks like in our clinic, you can email us or call or text us at (801) 980-2690.
Searching for a REMS certified Spravato clinic in Utah? Anew Therapy offers expert care and proven results. Schedule your free evaluation today.
