Signal of Miscarriage with Aripiprazole: A Disproportionality Analysis of the Japanese Adverse Drug Event Report Database

Sakai, Takamasa; Ohtsu, Fumiko; Mori, Chiyo; Tanabe, Kouichi; Goto, Nobuyuki

doi:10.1007/s40264-017-0560-z

Cited by 20 publications

(12 citation statements)

References 20 publications

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“…The JADER could be used to evaluate signals detected in global research and to generate hypotheses or identify trends in pharmacovigilance among specific populations (eg, pediatric individuals, geriatric individuals, and pregnant women). Sakai et al performed a study using the JADER and found a potential signal for miscarriage for aripiprazole, for which safety information during pregnancy was very limited …”

Section: Discussionmentioning

confidence: 99%

Quality evaluation of the Japanese Adverse Drug Event Report database (JADER)

Tsuchiya

Obara

Sakai

et al. 2019

Pharmacoepidemiology and Drug

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Introduction: The spontaneous adverse drug reaction (ADR) reporting system plays an important role in pharmacovigilance by providing information from clinical settings in the postmarketing environment. The Japanese Adverse Drug Event Report (JADER) database contains a portion of Japanese ADR reports, and no previous study has described the quality or characteristics of ADR reports in the JADER.Objective: The aim of this study was to identify the characteristics of the JADER database and to evaluate the quality of ADR reports contained in the JADER using the documentation-grading scheme developed by the World Health Organization.Methods: Of 478 508 ADR reports in the JADER, the analysis set consisted of 395 091 reports meeting inclusion criteria. An analysis was carried out to evaluate the quality of the reports according to the type of report, the type of sender, and the qualification of the reporter. Annual changes in the number of reports from medical institutions submitted by pharmacists were compared with changes in the number submitted by physicians.Results: The distribution of documentation grade differed according to the type of report, the type of sender, and the qualification of the reporter. Regarding "medical institution reports", the quality of reports was similar among qualification types, while the quality of reports submitted by physicians was higher for "company reports" and "study reports" (P < .0001, respectively). Conclusion:Our study showed that the quality of the ADR reports in the JADER differed among the type of report, the sender of the report, and the qualification of the reporter.

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Section: Discussionmentioning

confidence: 99%

Quality evaluation of the Japanese Adverse Drug Event Report database (JADER)

Tsuchiya

Obara

Sakai

et al. 2019

Pharmacoepidemiology and Drug

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“…Subgroup disproportionality analyses have been reported because of the possibility of bias when analyzing the association between drugs and pregnancy outcomes in datasets in which the majority of reports are from non-pregnant women [ 4 , 16 ]. Given that there is no dedicated field to identify pregnant women’s reports from the spontaneous reporting database, attempts are being made to identify such reports using the standard MedDRA query (SMQ) [ 3 , 5 , 17 ]. Therefore, in this study, we modified our previously reported method and used the following extraction method [ 3 , 17 ].…”

Section: Methodsmentioning

confidence: 99%

“…Given that there is no dedicated field to identify pregnant women’s reports from the spontaneous reporting database, attempts are being made to identify such reports using the standard MedDRA query (SMQ) [ 3 , 5 , 17 ]. Therefore, in this study, we modified our previously reported method and used the following extraction method [ 3 , 17 ].…”

Section: Methodsmentioning

confidence: 99%

“…However, these studies require a system to collect pregnant women and a sufficient number of cases to be conducted. Given the possibility that safety information for pregnant women can be obtained earlier by using spontaneous reports, some reports using the spontaneous reporting database have been reported [2][3][4][5][6]. Lareb, a pharmacovigilance center in the Netherlands, is also developing a toolkit for monitoring drug safety in pregnant women under the guidance of the World Health Organization, in which the use of a spontaneous reporting database is discussed [7].…”

Section: Introductionmentioning

confidence: 99%

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Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases

Sakai

Mori

Koshiba

et al. 2021

Drugs - Real World Outcomes

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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.

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“…Because of these limitations, causality between vaccines and adverse reactions from the JADER cannot be evaluated. However, the database enables the early detection of signals that can then be investigated more deeply [ 25 ]. To increase the availability and value of the JADER, age information as a continuous variable should be disclosed, especially in pediatric AEFI reports.…”

Section: Discussionmentioning

confidence: 99%

Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database

et al. 2020

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The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JADER from 2004 to 2017. The number of AEFI reports gradually increased among children aged <10 years and was the highest in 2011 among children aged 10–19 years. The number of suspected vaccines per AEFI report increased after 2011 among children aged <10 years. The percentage of “death” and “did not recover” as AEFI outcomes reported were 4.3% and 3.7% among children aged <10 years and 0.2% and 21.1% among children aged 10–19 years, respectively. The most frequently reported vaccine–reaction pair was Haemophilus influenzae type b conjugate vaccine and pyrexia among children aged <10 years and recombinant adsorbed bivalent human papillomavirus-like particle vaccine and a loss of consciousness among children aged 10–19 years. It is necessary to consider the Weber effects to understand the trend and characteristics of AEFI reporting because pharmacovigilance activity regarding vaccination is not sufficient in Japan.

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Signal of Miscarriage with Aripiprazole: A Disproportionality Analysis of the Japanese Adverse Drug Event Report Database

Cited by 20 publications

References 20 publications

Quality evaluation of the Japanese Adverse Drug Event Report database (JADER)

Quality evaluation of the Japanese Adverse Drug Event Report database (JADER)

Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases

Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database

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