title: [Safety profile of NO-SPA].
abstract: The aim of the safety analysis performed by Chinoin Drug Safety Unit was to summarise the safety profile of NO-SPA (drotaverine hydrochloride), the Hungarian spasmolytic well known in Hungary and abroad. Authors collected the safety data from clinical studies between 1964-1998 for the determination of the adverse event frequency. Based on the data of 12111 patients treated with NO-SPA in 37 clinical trials 0.9% frequency of adverse events was found. The value indicates uncommon (0.1-1%) adverse event frequency according to the criteria for frequency categories. The benefit-risk ratio of NO-SPA is favourable, since the therapeutic effect does not include frequent adverse reaction occurrence.
authors.affiliation: Chinoin Rt.-a Sanofi-Synthelabo vállalatcsoport tagja, Budapest.
authors.forename: Attila
authors.initials: A
authors.lastname: Tar
authors.forename: Júlia
authors.initials: J
authors.lastname: Singer
mesh_terms: D000700:Analgesics / Q000009:adverse effects*; D006801:Humans; D010208:Papaverine / Q000009:adverse effects* / Q000031:analogs & derivatives*; D010276:Parasympatholytics / Q000009:adverse effects*; D014665:Vasodilator Agents / Q000009:adverse effects*
chemical_list: D000700:Analgesics; D010276:Parasympatholytics; D014665:Vasodilator Agents; C005317:drotaverin; D010208:Papaverine