Citation

Etges T, Karolia K, Grint T, Taylor A, Lauder H, Daka B, Wright S. Ther. Clin. Risk Manag. 2016; 12: 1667-1675.

Copyright

(Copyright © 2016, Dove Press)

DOI

10.2147/TCRM.S115014

PMID

unavailable

Abstract

The global exposure of Sativex® (Δ9-tetrahydrocannabinol [THC]: cannabidiol [CBD], nabiximols) is estimated to be above 45,000 patient-years since it was given marketing approval for treating treatment-resistant spasticity in multiple sclerosis (MS). An observational registry to collect safety data from patients receiving THC: CBD was set up following its approval in the UK, Germany, and Switzerland, with the aim of determining its long-term safety in clinical practice. Twice a year, the Registry was opened to prescribing physicians to voluntarily report data on patients' use of THC: CBD, clinically significant adverse events (AEs), and special interest events. The Registry contains data from 941 patients with 2,213.98 patient-years of exposure. Within this cohort, 60% were reported as continuing treatment, while 83% were reported as benefiting from the treatment. Thirty-two percent of patients stopped treatment, with approximately one third citing lack of effectiveness and one quarter citing AEs. Psychiatric AEs of clinical significance were reported in 6% of the patients, 6% reported falls requiring medical attention, and suicidality was reported in 2%. Driving ability was reported to have worsened in 2% of patients, but improved in 7%. AEs were more common during the first month of treatment. The most common treatment-related AEs included dizziness (2.3%) and fatigue (1.7%). There were no signals to indicate abuse, diversion, or dependence. The long-term risk profile from the Registry is consistent with the known (labeled) safety profile of THC: CBD, and therefore supports it being a well-tolerated and beneficial medication for the treatment of MS spasticity. No evidence of new long-term safety concerns has emerged. © 2016 Etges et al.

Language: en

Keywords

adult; human; suicide; female; male; Germany; aged; United Kingdom; suicidal ideation; depression; Multiple sclerosis; psychosis; suicide attempt; intoxication; fatigue; major clinical study; mental disease; clinical practice; prescription; driving ability; somnolence; anxiety disorder; falling; treatment withdrawal; drug safety; Switzerland; drug dependence; drug fatality; long term care; drug cost; drug efficacy; drug tolerability; nausea; drug withdrawal; neurologic disease; relapse; cohort analysis; side effect; drug surveillance program; infection; lung cancer; malignant neoplastic disease; gastrointestinal disease; postmarketing surveillance; drug approval; register; digestive system injury; Spasticity; multiple sclerosis; pneumonia; dizziness; drug exposure; urinary tract infection; Article; observational study; mouth mucosa; evidence based practice; treatment duration; infestation; spasticity; Tetrahydrocannabinol; benign tumor; dysgeusia; nabiximols; Cannabidiol; Non-interventional; oral spray; prescription drug diversion; Risk management plan