@article{ref1,
title="An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex® (THC: CBD, nabiximols) oromucosal spray",
journal="Therapeutics and clinical risk management",
year="2016",
author="Etges, T. and Karolia, K. and Grint, T. and Taylor, A. and Lauder, H. and Daka, B. and Wright, S.",
volume="12",
number="",
pages="1667-1675",
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.<p /><p>Language: en</p>",
language="en",
issn="1176-6336",
doi="10.2147/TCRM.S115014",
url="http://dx.doi.org/10.2147/TCRM.S115014"
}