Pharmacoepidemiological Examination for the Safety of the Oral laxatives in the Elderly Patients / 医薬品情報学

ABSTRACT

<b>Objective: </b>Many of the elderly patients are suffering from constipation, are using the oral laxative.  However the risk assessment of the oral laxative is not performed.  Therefore, we used Japanese Adverse Drug Event Report database (JADER) and examined for the safety of the oral laxative in the elderly patients.<br><b>Methods: </b>Since the analysis target medicines; 12 oral laxatives and target ADEs; “digestive disorders” and “electrolyte abnormality,” the JADER database for April 2004 to January 2015 were analyzed in adults of age exceeds 60.  We used the reporting odds ratio for a safety index of drugs, using reporting odds ratio, when the Lower bound of the 95% two-sided confidence interval exceeds 1, it is the signal detection of ADE.<br><b>Results: </b>The oral laxatives detected the signal of “digestive disorders” were three medicines, and “electrolyte abnormality” were five medicines.  Especially, for electrolyte abnormalities not only increases the blood magnesium values as magnesium oxide, that there is also affect other electrolyte revealed.<br><b>Conclusion: </b>Some oral laxatives were also intended to signal detections of the adverse events that are not listed in the attached document, it is necessary to pay attention to the use of them for the elderly patients.