The Reagan-Udall Foundation for the FDA, in collaboration with the FDA, is hosting a hybrid public workshop on "Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest."
Identifying Safety Concerns and Potential Risks
Associated with the Use of Ketamine Products
Megan Ehret, PharmD, MS, BCPP
University of Maryland Baltimore School of Pharmacy
Tolerability & Safety
Psychiatric Side Effects
Dissociation- some literature shows decrease of disocciation over subsequent administrations, peaks within 40 minutes, resolves in 1-2 hours
CLinical Rating scales (CADSS) too challenging to adminsiter
Psycotomimetic - pre-existing vulnerability - (aka psychedelic)
Dizziness, drowsiness, light-headedness - fall risks
Long term exposure? Cellular or lolecular evidence of neurotoxicity - DOn’t know if we have the evidence yet
Hemodynmaic - increase in BP 10-50%, observed in 20-50 minutes of treatment
Resolve in 2-4 hours
with esketamine, we have the REMS that dictate when and what to measure
20-30% have increased BP
Identifying Safety Concerns and Potential Risks Associated with the Use of Ketamine Products Megan Ehret, PharmD, MS, BCPP University of Maryland Baltimore School of Pharmacy
Tolerability & Safety
Psychiatric Side Effects Dissociation- some literature shows decrease of disocciation over subsequent administrations, peaks within 40 minutes, resolves in 1-2 hours CLinical Rating scales (CADSS) too challenging to adminsiter Psycotomimetic - pre-existing vulnerability - (aka psychedelic) Dizziness, drowsiness, light-headedness - fall risks Long term exposure? Cellular or lolecular evidence of neurotoxicity - DOn’t know if we have the evidence yet
Hemodynmaic - increase in BP 10-50%, observed in 20-50 minutes of treatment Resolve in 2-4 hours
with esketamine, we have the REMS that dictate when and what to measure 20-30% have increased BP
Genitourinary - 20-40% of recreatinal users - nocturita, painful hematuria, dysuria, urinary urgency, incontinence - dose-dependent relationsip
Abuse Liability Increased liking, (cites 2017 and 2008 research)
Esketamine vs ketamine REMS?
Esketamine required to reduce occuraence of severity esketamine- increased risk of seadation, discoiation, repiratory dewpression after admin
Many providers see REMS as a barrier to esketamine prescription
Ketamine does not have a REMS