Evaluation of the Association of Hand-Foot Syndrome with Anticancer Drugs Using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) Databases

Sasaoka, Sayaka; Matsui, Teruo; Abe, Junko; Umetsu, Ryogo; Kato, Yamato; Ueda, Norifumi; Hane, Yuuki; Motooka, Yumi; Hatahira, Haruna; Yasutomi, Keita; Nakamura, Mitsuhiro

doi:10.1248/yakushi.15-00222

Cited by 15 publications

(20 citation statements)

References 25 publications

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“…Sasaoka et al reported that in their study of the time to onset for hand-foot syndrome during treatment with anticancer agents, for which they used JADER and FAERS, the input ratio of SAEs with capecitabine was 78% in JADER and 49% in FAERS. 8 The reporting ratios of time-to-onset information with TNF-I and IL-6-I in our study were similar to that for capecitabine in the previous study, but the ratio for MTX was lower. We suspect that because MTX had been administered as off-label use long before the approval for the RA indication, the safety profile of MTX was considered to have been established to some extent.…”

Section: Discussionsupporting

confidence: 88%

“…As studies that focused on the time to onset of AEs from drugs, investigations of suicide or diabetes with interferon formulations, osteonecrosis of the jaw with bisphosphonates, and hand-foot syndrome with anticancer agents have been reported. [8][9][10][11] Weaknesses of spontaneous-report databases, such as overreporting, underreporting, and missing data have been pointed out. 9,12 Since JADER is a spontaneous-report database, we need to recognize the existence of selection bias and reporting bias, and that some data are missing.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database

Matsuoka

Narukawa

2018

Ther Innov Regul Sci

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Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database

Matsuoka

Narukawa

2018

Ther Innov Regul Sci

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“…Median, quartile, and Weibull shape parameter (WSP) tests were used to evaluate the time-to-onset analysis [7–10]. We analyzed the time the specific adverse event occurred from when the prescription of specific drugs commenced by using the Weibull distribution parameter.…”

Section: Methodsmentioning

confidence: 99%

Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases

Hatahira

Abe

Hane

et al. 2017

J Pharm Health Care Sci

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BackgroundDrug-induced gingival hyperplasia (DIGH) causes problems with chewing, aesthetics, and pronunciation, and leads to the deterioration of the patient’s quality of life (QOL). Thus, the aim of this study was to evaluate the incidence of DIGH using spontaneous reporting system (SRS) databases.MethodsWe analyzed reports of DIGH from SRS databases and calculated the reporting odds ratios (RORs) of suspected drugs (immunosuppressants, calcium channel blockers, and anticonvulsants). The SRS databases used were the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) database. With the data, we evaluated the time-to-onset profile and the hazard type using the Weibull shape parameter (WSP). Furthermore, we used the association rule mining technique to discover undetected relationships such as possible risk factors.ResultsThe FAERS contained 5,821,716 reports. The RORs (95% confidence interval: CI) for cyclosporine, everolimus, sirolimus, mycophenolate mofetil, amlodipine, nifedipine, carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, and valproic acid, were 39.4 (95% CI: 30.3–51.2), 4.2 (1.7–10.0), 6.6 (2.5–17.7), 13.1 (7.2–23.2), 94.8 (80.0–112.9), 57.9 (35.7–94.0), 15.1 (10.3–22.3), 65.4 (33.8–126.7), 6.5 (3.6–11.8), 19.7 (8.8–44.0), 65.4 (52.4–82.9), 56.5 (21.1–151.7), 2.9 (1.1–7.7), and 17.5 (12.6–24.4), respectively. The JADER database contained 430,587 reports. The median time-to-onset of gingival hyperplasia values for immunosuppressants, calcium channel blockers, and anticonvulsants use were 71, 262, and 37 days, respectively. Furthermore, the 95% CI of the WSP β for anticonvulsants was over and excluded 1, which meant that they were wear-out failure type.ConclusionsOur results suggest that DIGH monitoring of patients administered immunosuppressants, calcium channel blockers, or anticonvulsants is important. We demonstrated the potential risk of DIGH following the long-term use of calcium channel blocker over approximately 260 days. Based on the results of the association rule mining approach, patients with intellectual disability who are administered phenytoin should be monitored carefully. We recommend that patients who experience symptoms related to DIGH should be closely monitored.

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“…If β is greater than 1 and the 95% CI of β excludes the value of 1, the hazard is considered to increase over time. [17][18][19][20]24,25) We investigated the relation between the number of reports and seasonality of DIP. We analyzed the onset day of AEs and then obtained the number of AE reports per month between April 2004 and November 2016 from REAC table of JADER.…”

Section: 23)mentioning

confidence: 99%

Evaluation of Drug-Induced Photosensitivity Using the Japanese Adverse Drug Event Report (JADER) Database

Nakao

Hatahira

Sasaoka

et al. 2017

Biological & Pharmaceutical Bulletin

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Drug-induced photosensitivity (DIP) refers to the development of cutaneous disorders caused by the combined effects of different medications and light. The aim of this study was to obtain new information on drug risk comparisons and on DIP onset profiles, including seasonal variations, for clinically used prescription drugs. We analyzed reports of DIP recorded in the Japanese Adverse Drug Event Report (JADER) database using a reporting odds ratio (ROR). We also used Key words photosensitivity; Japanese Adverse Drug Event Report database; seasonal variation; ketoprofen; hydrochlorothiazide Drug-induced photosensitivity (DIP) refers to the development of cutaneous disorders caused by the combined effects of a variety medications (oral, intravenous, and dermal) and light.1) Although the pathogenesis of DIP reactions is not fully understood, they can be classified as phototoxic or photoallergic drug eruptions.2) The clinical manifestation of phototoxicity is an exaggerated sunburn with blistering, desquamation, and hyperpigmentation, while that of photoallergy is dermatitis.3) Many drugs are associated with photosensitivity. The common photosensitizing medications include antibiotics, antifungals, antihistamines, cholesterol-lowering drugs, diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), oral contraceptives and estrogens, phenothiazines, psoralens, retinoids, sulfonamides, sulfonylureas used for type 2 diabetes, and alpha-hydroxy acids used in cosmetics.

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Evaluation of the Association of Hand-Foot Syndrome with Anticancer Drugs Using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) Databases

Cited by 15 publications

References 25 publications

Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database

Comparison of Serious Adverse Event Profiles Among Antirheumatic Agents Using Japanese Adverse Drug Event Report Database

Drug-induced gingival hyperplasia: a retrospective study using spontaneous reporting system databases

Evaluation of Drug-Induced Photosensitivity Using the Japanese Adverse Drug Event Report (JADER) Database

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