The study aim was to assess the abuse/misuse potential of second‐generation antipsychotics (SGAPs) using VigiBase data. We extracted individual case safety reports of “Drug abuse, dependence and withdrawal” involving SGAPs up to June 2018. We assessed disproportionate reporting by calculating the information component, considering the lower end of the 95% credibility interval for the information component (IC025), and the proportional reporting ratio. We identified 1683 individual case safety reports recorded as “abuse, dependence and withdrawal” involving SGAPs, mainly quetiapine (n = 1089) and olanzapine (n = 209). The disproportional reporting indicators highlighted an association between “Drug abuse and dependence”, and quetiapine, olanzapine and ziprasidone, as indicated by the IC025 (2.263, 0.259 and 1.051, respectively) and proportional reporting ratio values (3.929, 1.020 and 1.334, respectively). The abuse/misuse potential is confirmed for quetiapine and olanzapine and highlighted for the first time for ziprasidone. Physicians should consider these risks when prescribing these antipsychotics, especially to patients with history of drug abuse.

Background Spasticity is a common and disabling symptom of multiple sclerosis (MS). The management of MS spasticity is centred around relief and functional improvement, evaluated with the Expanded Disability Status Scale (EDSS). Sativex oromucosal spray is a cannabinoid-based medicine used for adult MS patients with moderate to severe spasticity who do not respond adequately to first-line antispasticity medications. The patients who responded to Sativex showed an improvement from baseline in spasticity !20%-30% evaluated with a numerical rating scale (NRS) scores. 1 Purpose The aim of the study was to review the use of oromucosal spray Sativex in patients with moderate to severe MS. Material and methods A retrospective cohort study was conducted in patients who began using Sativex between January 2016 and June 2018. The data was retrieved from the webbased register of the Italian Medicines Agency. The primary endpoint was the change in the degree of severity of spasticity assessed by the NRS scale and the evaluation of adverse effects in order to assess safety. The efficacy of Sativex was established by a medium reduction of 20%, according to the NRS scale, from the value at the baseline to the value of the last re-evaluation of the disease. The adverse effects were evaluated during the whole period considered. Results Thirty-seven patients were evaluated, 70.27% of these were female. The medium age was 56±9 years, the mean NRS and the mean EDSS score before treatment was 7.86 ±1.00 and 5.95±1,47, respectively. A medium correlation was found between NRS and EDSS score (R=0.669; F=29.903; p<0.0001). The NRS score after treatment was 5.66±1.04 (D= À2,20±0.68), with a statistical significance (Z=-5,829; p<0.00001). All patients obtained a reduction >20% of the NRS score. The adverse effects detected were fatigue (8.1%), nausea (5.4%), headache (5.4%) and vertigo (2.7%). Conclusion The symptomatic relief of spasticity led to quantifiable benefits in the ability to perform daily activities and it improved the patients' quality of life. These findings are in line with other studies, which show the use of Sativex as effective and well tolerated for the management of the spasticity of patients with MS with moderate to severe grade symptoms.