Abstract
Although a large number of patients drive an automobile while using drugs for the treatment of chronic or acute diseases, the status of traffic accidents related to such drugs is unclear. To address this, a survey was conducted using the Japanese Adverse Drug Event Report database（JADER）organized by the Pharmaceuticals and Medical Devices Agency. Within the period between April 2004 and March 2016, the total number of registered events was 390,669, 342 of which were traffic accidents reported as adverse drug events. On calculating the ROR（reporting odds ratio）and lower limit of a 95％ confidence interval for 176 suspected drugs, the latter exceeded 1 in 82 cases, suggesting an association. Pramipexole hydrochloride hydrate was associated with traffic accidents the most frequently（47）, and sudden sleep occurred in 36 of such cases. This was followed by zolpidem tartrate（46）, pregabalin（35）, varenicline tartrate（19）, and sulpiride（13）. In the majority of these cases, the package insert specified driving and similar activities as contraindications, or indicated precautions to be adopted when performing them. With aging, the importance of guidance on care or necessary drugs for patients who drive an automobile will further increase. Thus, it is necessary for doctors and pharmacists to provide appropriate advice to such patients, and the results of the present study may be useful for this.
