Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database

Sasaoka, Sayaka; Hatahira, Haruna; Hasegawa, Shiori; Motooka, Yumi; Fukuda, Akiho; Naganuma, Misa; Umetsu, Ryogo; Nakao, Shin-ichi; Shimauchi, Akari; Ueda, Norifumi; Hirade, Kouseki; Iguchi, Kazuhiro; Nakamura, Mitsuhiro

doi:10.1248/yakushi.17-00172

Cited by 8 publications

(5 citation statements)

References 10 publications

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“…These findings build on a small but growing body of evidence supporting the use of voluntary reporting data for pharmacovigilance of OTC and non-prescription medicines. Similar signals for OTC medicines have been reported in a large study using the Japanese Adverse Event Report Database where safety signals for OTC analgesic and antipyretic agents [ 23 ], as well as OTC cough and cold medicines [ 24 ] were detected. Looking internationally, safety signals for OTC medicines have been reported in the Dutch Lareb dataset [ 2 ], and the findings from our study extend the evidence supporting the use of spontaneous ADR reporting data for pharmacovigilance of OTC medicines, to include the Asia Pacific and North American regions.…”

Section: Discussionsupporting

confidence: 76%

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding

Amatya¹,

Fois²,

Williams

et al. 2020

Pharmacy

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One post-marketing surveillance challenge for many regulatory authorities is access to information regarding the safety of over-the-counter (OTC) medicines. National spontaneous adverse drug reaction (ADR) report data represent a rich potential data source for the detection of safety signals associated with OTC medicines, yet little is known regarding the possibility of detecting safety signals for OTC medicines within these datasets. The aim of this study was to evaluate the potential for detecting safety signals for OTC medicines in National ADR spontaneous reporting data, using OTC non-steroidal anti-inflammatory drugs (NSAIDs) and gastrointestinal bleeding as an example. Data from the Australian Adverse Drug Reactions System (ADRS) dataset (1971–2008) and the Canadian Vigilance Adverse Reaction Online Database (VAROD) (1965–2013) were used to explore the feasibility of using spontaneous reporting data, exploring the association between gastrointestinal bleeding and the use of OTC NSAIDs. Safety signals were examined using disproportionality analyses and reporting odds ratios calculated. After adjusting for age, gender, medications known to increase the risk of bleeding, and medications used for the management of conditions associated with an increased risk of bleeding, a two-fold increase in the risk of gastrointestinal (GI) bleeding with OTC NSAID was observed within each dataset. This study demonstrates that spontaneous ADR reporting data can be used in pharmacovigilance to monitor the safety of OTC medicines.

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Section: Discussionsupporting

confidence: 76%

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding

Amatya¹,

Fois²,

Williams

et al. 2020

Pharmacy

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“…From April 2004 to November 2016, side effects of OTC cold medicine in Japan were reported in 1276 cases, including 88 cases involving the respiratory system, thorax, and mediastinum (fourth place) [ 1 ]. Besides acetaminophen, drug-induced interstitial lung disease caused by ibuprofen-containing OTC cold medicine has been reported.…”

Section: Discussionmentioning

confidence: 99%

“…If more cold medicine is required on another occasion or in another store, the drugstore clerk might sell it without checking the patient’s medication history. Although the prevalence is low, drug-induced interstitial lung disease cases due to OTC cold medicine are being reported [ 1 ]. The mechanisms through which drug-induced lung disease occurs are likely to involve direct damage to alveolar epithelial or capillary endothelial cells, dysregulation of the immune system, systemic cytokine release, cell-mediated lung damage, and free radical production with oxidative injury [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Drug-induced interstitial lung disease due to over-the-counter cold medicine taken daily for 25 years: a case report

2023

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Introduction We report a rare case of drug-induced interstitial lung disease due to over-the-counter cold medicine taken daily for 25 years to clear the patient’s head. Case presentation A 77-year-old Japanese man presented to our hospital with a worsening cough that started 5 years ago. Chest radiographs and computed tomography images showed bilateral opacities, and transbronchial lung biopsy specimens showed an organizing pneumonia pattern. He reported taking the same over-the-counter cold medicine daily for the past 25 years to clear his head. We suspected that the cold medicine caused the lung opacities and asked him to stop taking them. His cough, general fatigue, and chest infiltrate gradually diminished. However, 6 months later, he resumed the same treatment because of a cold. The following month, he presented with severe worsening cough and chest radiographical findings. We diagnosed drug-induced interstitial lung disease. He improved by stopping the cold medicine again and taking prednisolone. Conclusions Over-the-counter cold medicines are easily accessible at the drugstore. In cases of diffuse lung disease, we should consider drug-induced interstitial lung disease due to over-the-counter cold medicine, which patients have been taking not only for weeks or months but also years.

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“…Spontaneous reporting systems (SRSs) such as the Food and Drug Administration Adverse Event Reporting System (FAERS), the Japanese Adverse Drug Event Report (JADER) database, and the database of the WHO Programme for International Drug Monitoring (VigiBase ) are used to evaluate the risk of adverse drug events. [8][9][10][11] Most cases of adverse drug reactions are reported to these systems by patients themselves or healthcare professionals. However, few studies have investigated the associations between drugs and the risk of DILI with adjustment for potential confounding factors including age and sex.…”

Section: Introductionmentioning

confidence: 99%

Signal Detection of Potential Hepatotoxic Drugs: Case-Control Study Using Both a Spontaneous Reporting System and Electronic Medical Records

Akimoto

Nagashima

Minagawa

et al. 2021

Biological & Pharmaceutical Bulletin

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Drug-induced liver injury (DILI) is a common adverse drug event. Spontaneous reporting systems such as the Japanese Adverse Event Report Database (JADER) have been used to evaluate the association between drugs and adverse drug events. However, the association of drugs with adverse drug events may be overestimated due to reporting biases. Therefore, it is important to objectively evaluate the association using liver function test values. The aim of the present study was to predict potential hepatotoxic drugs using real-world data including electronic medical records and the JADER database. A total of 70009 (2779 with DILI and 67230 without DILI) and 438515 (10235 with DILI and 428280 without DILI) Japanese adult patients were extracted from electronic medical records and the JADER database, respectively. Drugs with ≥100 DILI patients in both of the two databases were regarded as suspected drugs for DILI. We used multivariate logistic regression to evaluate the association between the suspected drugs and increased risk of DILI. Among the suspected drugs, broad-spectrum antibiotics such as meropenem, tazobactam/piperacillin and ceftriaxone were significantly associated with an increased risk of DILI, and meropenem had a greater risk of DILI in both of the two databases. Additionally, there were significant associations of mosapride and L-carbocisteine with increased risk of DILI. In addition to well-known associations between antibiotic drugs and DILI, mosapride and L-carbocisteine were found to be new potential signals of drugs causing hepatotoxicity. This study indicates potential hepatotoxic drugs that require further causality assessment.

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Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database

Cited by 8 publications

References 10 publications

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding

Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding

Drug-induced interstitial lung disease due to over-the-counter cold medicine taken daily for 25 years: a case report

Signal Detection of Potential Hepatotoxic Drugs: Case-Control Study Using Both a Spontaneous Reporting System and Electronic Medical Records

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