Factorial Analysis of Hepatitis B Virus Reactivation-Induced Hepatitis B Using JADER

Hara, Ayako; Matsumoto, Kazuaki; Yokoyama, Yuta; Kizu, Junko

doi:10.1248/bpb.b16-00765

Cited by 11 publications

(10 citation statements)

References 19 publications

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“…Bohnert et al reported that among patients receiving opioid prescriptions for pain, a higher morphine equivalent dose of ≥100 mg/d was associated with an increased risk of opioid overdose-related death. 29) As shown in Fig. 2, the median daily dose of transdermal fentanyl was 120 mg of oral morphine equivalent, whereas the oral morphine and oxycodone doses were comparably low (30 mg of oral morphine equivalents).…”

Section: Discussionmentioning

confidence: 91%

“…Furthermore, several studies reported that patients using opioids with a daily morphine equivalent dose as low as 20 to 50 mg can also experience life-threatening respiratory or CNS depression under impairment of hepatic or renal function, or concomitant use of CNS depressants such as benzodiazepines, antidepressants, and alcohol. 27,29) The usefulness of the Weibull distribution for profiling the time-to-onset of ADEs has been reported. 11,12,[30][31][32] To the best of our knowledge, no time-to-onset analysis of respiratory depression for opioids in cancer patients has been done using SRSs.…”

Section: Discussionmentioning

confidence: 99%

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Analyses of Respiratory Depression Associated with Opioids in Cancer Patients Based on the Japanese Adverse Drug Event Report Database

Sugawara

Uchida

Suzuki

et al. 2019

Biological & Pharmaceutical Bulletin

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Opioid-induced respiratory depression is a potentially life-threatening adverse drug event. The purpose of this study was to evaluate the incidence of respiratory depression using the Japanese Adverse Drug Event Report (JADER) Database to obtain data to promote proper use of opioids. The JADER database from April 2004 to March 2017 was obtained from the Pharmaceuticals and Medical Devices Agency. We calculated the reporting odds ratios (RORs) of suspected opioids (morphine, fentanyl, oxycodone, tapentadol, methadone, tramadol, pentazocine, buprenorphine, and codeine phosphate hydrate), analyzed the daily dose at first appearance and the time-to-onset profile, and assessed the hazard type using the Weibull shape parameter. ROR analysis detected adverse event signals for all opioids. Morphine showed a large ROR value with statistical significance in elderly (≥70 years old) patients. The median daily doses of oral morphine and oxycodone for inducing respiratory depression were comparably low (30 mg/d as oral morphine equivalent dose), while that of transdermal fentanyl was 120 mg/d (oral morphine equivalent dose). On time-to-onset analysis using the Weibull distribution, those opioids were classified as the early failure type. The median time-to-onset of oral morphine, oral oxycodone and transdermal fentanyl was 5.5, 11 and 12.5 d, respectively, and almost 50% of cases were reported within 30 d. Taken together, our results suggest that it is important to monitor patients carefully for at least the first one week to one month, even if opioids are administered at a relatively low dose, especially in elderly patients administered morphine.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Analyses of Respiratory Depression Associated with Opioids in Cancer Patients Based on the Japanese Adverse Drug Event Report Database

Sugawara

Uchida

Suzuki

et al. 2019

Biological & Pharmaceutical Bulletin

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“…An automated reporting system is needed to obtain data for a database with an aim for reducing cost and labor . In the United States, Korea, and Japan, the signal detection for adverse events was investigated using databases, including spontaneous adverse event reporting databases . The US Food and Drug Administration launched the “Sentinel Initiative” to expand postmarketing safety data analysis, which is still investigational, especially for anticancer drugs.…”

Section: Discussionmentioning

confidence: 99%

“…23 In the United States, Korea, and Japan, the signal detection for adverse events was investigated using databases, including spontaneous adverse event reporting databases. [24][25][26][27] The US Food and Drug Administration launched the "Sentinel Initiative" to expand postmarketing safety data analysis, 28 which is still investigational, especially for anticancer drugs. Careful analysis between the costs of creating extremely large databases and obtaining meaningful clinical information must also be conducted.…”

Section: All-case Surveillance Of Oncology Drugs In Japanmentioning

confidence: 99%

Does Industry‐Conducted All‐Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan?

Suzuki

Sato

Sasaki

2019

Clinical Translational Sci

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In Japan, the Pharmaceuticals and Medical Devices Agency requires all‐case surveillance studies (ACSS) for many novel oncology drugs as a condition for approval. However, this is a major burden on the pharmaceutical industry and clinicians. The objective of this analysis was to investigate whether ACSS can contribute essential new information on severe adverse drug reactions, which are necessary to revise the package inserts of drugs. All oncology drugs for which ACSS were required from January 2006–September 2015 found on the Pharmaceuticals and Medical Devices Agency website were reviewed, and the influence of ACSS on the package insert content was evaluated. Most of the package insert revisions regarding serious treatment‐related adverse events were based on spontaneous reports from clinicians. The contribution of ACSS results to the revision of package inserts is limited and comes at the cost of financial resources and labor. An alternative, more efficient adverse‐event reporting system is necessary.

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“…In Japan, the Pharmaceutical and Medical Device Agency (PMDA) has collected spontaneous adverse event reports of drugs for medical use, non-prescription drugs, and drugs requiring guidance since 2004, and more than 300000 adverse event reports are open to the public as the Japanese Adverse Drug Event Report (JADER). JADER has been utilized in many retrospective studies, [1][2][3] playing a major role in the safety evaluation of drugs in clinical practice sites in Japan. 4) The U.S. Food and Drug Administration (FDA) opened the FDA's Adverse Event Reporting System (FAERS) to the public, which is also a spontaneous adverse event report database similar to JADER.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Expression Time of Ganciclovir-Induced Adverse Events Using JADER and FAERS

Ando

Taguchi

Enoki

et al. 2019

Biological & Pharmaceutical Bulletin

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Investigation of the occurrence time of adverse drug reactions helps to prevent the development and aggravation of adverse reactions, but the expression time of ganciclovir-induced adverse events has not been elucidated. In this study, using databases of spontaneous adverse event reports, the Japanese Adverse Drug Event Report database (JADER) and the U.S. Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS), the incidence of adverse reactions due to ganciclovir and their expression time were analyzed. As a result of calculation of the reporting odds ratio (ROR) and 95% confidence interval for individual main adverse reactions of ganciclovir (cytopenia, leukopenia, thrombocytopenia, liver damage, and acute renal failure), a signal was detected for all adverse reactions in both databases, except for liver damage in JADER. Furthermore, the Weibull distribution was performed for the analysis of onset time of each ganciclovir-induced adverse event. The results of Weibull parameter α and β values of each adverse event in both JADER and FAERS suggested that most adverse events occurred within 30 d and classified into the early failure type, except that thrombocytopenia and acute renal failure in JADER classified into the random failure type. Based on these findings, it concluded that the paying attention to signs of each ganciclovirinduced adverse event is required from the early phase after ganciclovir administration. However, in FAERS, development after a long-term course also accounted for 11%, suggesting that long-term periodic monitoring of adverse reactions would be also required.

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Factorial Analysis of Hepatitis B Virus Reactivation-Induced Hepatitis B Using JADER

Cited by 11 publications

References 19 publications

Analyses of Respiratory Depression Associated with Opioids in Cancer Patients Based on the Japanese Adverse Drug Event Report Database

Analyses of Respiratory Depression Associated with Opioids in Cancer Patients Based on the Japanese Adverse Drug Event Report Database

Does Industry‐Conducted All‐Case Surveillance of Newly Approved Oncology Drugs Contribute to the Revision of Package Inserts in Japan?

Evaluation of the Expression Time of Ganciclovir-Induced Adverse Events Using JADER and FAERS

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