Background There is limited research regarding the use of glaucoma medicines during pregnancy. Prostaglandins contract uterine smooth muscle; however, it is not clear whether prostaglandin eye drops are associated with pregnancy loss in pregnant women. Objectives We conducted a pharmacovigilance study using spontaneous report databases from Japan and the USA to evaluate the association between pregnancy loss and the use of prostaglandin eye drops during pregnancy. Methods The Japanese Adverse Drug Event Report database and the Food and Drug Administration Adverse Event Reporting System were used for analysis. Disproportionality analyses and a review of individual case safety reports were conducted. Results As for prostaglandin eye drops in pregnancy-related reports, there were eight reports involving latanoprost in the Japanese Adverse Drug Event Report database and no reports of pregnant women using other prostaglandin eye drops. In the Food and Drug Administration Adverse Event Reporting System, there were 25 reports involving latanoprost, 23 involving bimatoprost, 13 involving travoprost, and three involving tafluprost. The drug safety signal was detected during latanoprost usage and pregnancy loss. In the Japanese Adverse Drug Event Report database, there were five reports of pregnancy loss related to latanoprost, with a reporting odds ratio of 12.84 (95% confidence interval 3.06–53.86), and in the Food and Drug Administration Adverse Event Reporting System, pregnancy loss was reported in 12 cases of latanoprost usage with a reporting odds ratio of 4.35 (95% confidence interval 1.98–9.54). Uterine contractions were observed as concomitant adverse events in one case. Conclusions Although a disproportionality analysis cannot determine causality, we need to keep an eye on the signal detected in this study. This signal should be validated using a causal design study.

Through our analysis of the Japanese Adverse Drug Event Report database, we found a potential signal for miscarriage for aripiprazole. Safety information on the use of aripiprazole during pregnancy is very limited. Therefore, we suggest that the potential signal detected in our analysis be explored further.

BackgroundPatients and their families are able to obtain information about palliative care from websites easily nowadays. However, there are concerns on the accuracy of information on the Web and how up to date it is.ObjectiveThe objective of this study was to elucidate problematic points of medical information about palliative care obtained from websites, and to compare the quality of the information between Japanese and US websites.MethodsWe searched Google Japan and Google USA for websites relating to palliative care. We then evaluated the top 50 websites from each search using the DISCERN and LIDA instruments.ResultsWe found that Japanese websites were given a lower evaluation of reliability than US websites. In 3 LIDA instrument subcategories—engagability (P<.001), currency (P=.001), and content production procedure (P<.001)—US websites scored significantly higher and had large effect sizes.ConclusionsOur results suggest that Japanese websites have problems with the frequency with which they are updated, their update procedures and policies, and the scrutiny process the evidence must undergo. Additionally, there was a weak association between search ranking and reliability, and simultaneously we found that reliability could not be assessed by search ranking alone.

Safety information regarding drug use during pregnancy is insu‹cient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identiˆed reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/infant cardiovascular events. The PRR and ROR values diŠered between all reports in the JADER database and those on pregnant women, aŠecting whether signal detection criteria were met. Therefore we considered that reports on pregnant women should be used when risks associated with pregnancy were determined using signal detection. Analyses of MMI embryopathy revealed MMI signals ［PRR, 159.7; ROR, 669.9; 95％ conˆdence interval (CI), 282.4 1588.7] but no propylthiouracil signals (PRR, 1.98; ROR, 2.0; 95％CI, 0.3 15.4). Theseˆndings were consistent with those of reported risks. Analyses of fetal/infant cardiovascular events revealed ritodrine signals (PRR, 2.1; ROR, 2.1; 95％CI, 1.4 3.3). Theseˆndings were also consistent with reported risks. Mining the JADER database was helpful for analyzing adverse drug reactions in pregnant women.

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