Objective:Many epidemiological studies revealed that the varicella and herpes zoster have inverse correlation. This paper examines to confirm these associations by using Prescription Surveillance. Design: Multiple regression analysis about association between the incidence rate of herpes zoster and varicella adjusting for prefecture, fiscal year and week. Methods: We used the general public data from Prescription Surveillance. Prescription Surveillance estimates the number of patients who were prescribed anti-varicella zoster virus drug with age class. We assumed the patients under 15 years old were varicella patients, and over 65 years old were herpes zoster patients. Each the number of patient was aggregated by week and prefecture from April 5, 2010 to March 31, 2013. We regressed the incidence rate of herpes zoster on the incidence rate of varicella adjusting for prefecture, fiscal year and week. Moreover, we regressed it on the several lag of the incidence rate of varicella. Results: The incidence rate of varicella was significantly positive, however the estimated coefficient was 0.030. The lag of incidence rate of varicella were also significantly positive, however these estimated coefficient were less than 0.030. Conclusion: We found that the incidence rate of herpes zoster and varicella have positive correlation, however its magnitude was not so important. It needs attention that our finding means positive correlation when we remove seasonality and regionality of both incidences.

The Japanese Ministry of Health, Labor, and Welfare lists interstitial lung disease as an serious adverse drug event.  The Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) databases are available to detect adverse events signals.  We analyzed reports of interstitial lung disease in FAERS and JADER and calculated the reporting fraction and reporting odds ratio (ROR) of drugs potentially associated with interstitial lung disease.  We applied Weibull shape parameter to time-to-event data in JADER.  We found FAERS to contain 3,522,995 reports from January 2004 to March 2013 and JADER to contain 292,720 reports from April 2004 to November 2013.  In FAERS, the reporting fractions of interstitial lung disease for Gefitinib, Bleomycin, and Amiodarone were 7.4% (285/3,856 reports), 3.2% (86/2,663 reports), and 1.9% (357/18,366 reports), and RORs (95% confidence interval [CI]) were 29.26 (25.89-33.07), 11.99 (9.66-14.88), and 7.29 (6.55-8.11), respectively.  In JADER, the reporting fractions of interstitial lung disease for Gefitinib, Bleomycin, and Amiodarone were 45.6% (1,070/2,348 reports), 22.1% (77/348 reports), and 27.9% (468/1,678 reports), and RORs (95% CI) were 18.46 (16.99-20.06), 5.83 (4.52-7.51), and 8.14 (7.31-9.07), respectively.  Adverse event signals of interstitial lung disease were observed in most drugs, which are warned as a suspected drug in the literature.  With the time-to-event analysis using Weibull shape parameter, time-dependency of adverse events in each drug was different.  Therefore, these drugs should be used carefully in clinical practice.

There have been concerns that neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) cause neuropsychiatric adverse events (NPAEs).  We evaluated the number of relevant reports, reporting ratio, and reporting odds ratio (ROR) by using spontaneous reporting database, such as the Japanese Adverse Drug Event Report (JADER) (April 2004 to July 2014).  The RORs of oseltamivir, zanamivir, laninamivir, and peramivir were 11.8 (95% confidence interval (CI), 10.8-13.0), 47.0 (95% CI, 40.0-55.3), 9.5 (95% CI, 6.8-13.2), and 3.3 (95% CI, 2.1-5.1), respectively.  The lower limit of the ROR 95% CI of NPAEs of all neuraminidase inhibitors was ≥1.  We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model.  The adjusted ROR of NPAEs was 66.9 (95% CI, 50.3-88.9) in male patients treated with osletamivir aged 10-19 years.  The adjusted RORs of NPAEs were increased in male and female patients under the age of 20 years.  Neuraminidase inhibitors including oseltamivir treatment could be associated with NPAEs.  Therefore, these drugs should be used carefully in clinical practice.

Introduction: Dermatological disorders are one of the adverse events caused by cancer chemotherapy and are a dose-limiting factor for some anti-neoplastic agents.  The severe symptoms associated with these disorders affect the patients’ quality of life (QOL).  Early countermeasures for the onset of dermatological disorders associated with anti-neoplastic agent administration might be important.
Materials and Methods: We analyzed the occurrences of dermatological disorders after administration of an anti-neoplastic agent in the Food and Drug Administration Adverse Event Reporting System (FAERS), and compared the adverse event (AE) reporting ratio of the total reports.  In addition, we studied the association between anti-neoplastic agents and dermatological disorders using cluster analysis.  Reports for 15 anti-neoplastic agents (4 anti-neoplastic agents and 11 molecular target drugs) were analyzed.
Results: After excluding duplicate data in FAERS, 6,157,897 reports were analyzed.  The number of reports that showed a dermatological disorder was 534,934.  The reporting ratio of hand-foot syndrome with sorafenib and capecitabine was 11.20% and 7.05%, respectively.
Conclusions: We set the cluster number at six; cluster features obtained were as follows: (1) the reporting ratio of hand-foot syndrome was especially high, followed by the reporting ratio of rash, (2) the reporting ratio of rash and erythema was high.  Similar anti-neoplastic agents may demonstrate similar occurrence tendencies of AEs and cluster features.  Further studies are required to draw conclusions over these findings.  Information services based on the feature of each cluster might be useful to improve patient QOL at the clinical site.