Hyponatremia in elderly patients treated with desmopressin for nocturia: a review of a case series

Objective: Lately, desmopressin (dDAVP) administered orally has been demonstrated to be an effective alternative in the management of nocturia in adults. Although the safety profile of dDAVP is well known, much of the experience originates from studies in enuretic children and younger adults, and it may not be readily extrapolated to elderly patients. In order to identify factors associated with an increased risk of hyponatremia in elderly patients treated with dDAVP for nocturia, we analysed spontaneous reports accrued from clinical practice in Denmark and Sweden. Method: Following a selection procedure, the study base comprised 15 case reports. From the included reports, information was sought on concurrent diseases, concomitant medications and other factors that may predispose elderly patients to hyponatremia when treated with desmopressin. Results: The median age amongst the cases was 81 years (range 61-93 years) and 80% were females. For seven of the patients, the hyponatremia occurred during the first 3 weeks of treatment. The symptoms presented by the patients led to hospitalisation in all but one case. Among patients with information available on concomitant medication, half of them were treated with cyclooxygenase inhibitors. An excessive fluid intake could only be ascertained in one case; all 15 patients eventually recovered. Conclusion: In elderly patients treated with dDAVP for nocturia, an increased risk of hyponatremia exists in the first weeks of treatment. Compared with younger subjects, risk factors other than excessive intake of fluid appear to contribute to this adverse drug reaction

Direct-acting oral anticoagulants (DOACs) in pregnancy: new insight from VigiBase ®

We aimed to perform an analysis of individual case safety reports retrieved after the Standardized MedDRA Query “Pregnancy and neonatal topics” for which Direct-Acting Oral Anticoagulants (DOACs) were claimed as suspected/interacting drugs. Additionally, to investigate if exists a disproportion of cases reporting “Pregnancy and neonatal topics” adverse events rather than other adverse events for DOACs in comparison with all other drugs registered in VigiBase or warfarin. VigiBase, the World Health Organization (WHO)’s global database of individual case safety reports was used as data source. Forty-two cases of abortion were detected of which 18 (42.8%) had alternative causes for its occurrence. Fourteen cases reported congenital anomaly (8 cases) or low birth weight baby/fetal growth restriction (6 cases) of which 62.5% and 33.3% had at least one confounder, respectively. In the disproportionality analyses, a potential safety signal for spontaneous abortion emerged for rivaroxaban (Reporting Odds Ratio, ROR 2.70; 95% CI 1.79–4.07) and apixaban (ROR 6.76; 95% CI 2.99–15.25). However, when the same analyses were performed using only cases without alternative causes, no statistically significant associations for rivaroxaban when compared to all other drugs (ROR 1.05; 95% CI 0.54–2.02) or warfarin (ROR 0.79; 95% CI 0.47–1.32) were found. For apixaban, we found a statistically significant ROR for induced abortion when compared to all other drugs or warfarin. For the majority of cases claiming DOACs-induced teratogenic effects, spontaneous or induced abortion there was at least one alternative cause explaining the occurrence of the adverse events. For rivaroxaban, when cases without confounders were considered, no safety signals emerged. However, for apixaban, we found a potential safety signal suggesting an increased probability of reporting spontaneous/induced abortion rather than other events when compared to all other drugs or warfarin