2010 Volume 24 Issue 5 Pages 693-704
A post-marketing surveillance study was carried out to investigate the safety and efficacy of long-term administration of Onon Dry Syrup 10% (Pranlukast hydrate) in actual clinical settings in patients who were traceable among those eligible for the former prospective survey. A total of 55 cases were collected from 33 medical institutions all over Japan. Thirty four patients were under the medication for more than 1 year.
Among 55 patients included in the safety analysis population, an adverse drug reaction occurred in 1 case (incidence of 1.82%), which was a non-serious case of liver function disorder.
Among 50 patients included in the efficacy analysis population, 46 showed improvement (improvement rate of 92.0%). The result of the analysis by patient background factors showed no special concern with the effectiveness of the drug.
In conclusion, it was confirmed that Onon Dry Syrup is a highly safe and effective medication for bronchial asthma when administered in infants aged less than 1 year for a long-time of period.
