Adverse drug event profile associated with pregabalin among patients with and without cancer: analysis of a spontaneous reporting database

Kose, Eiji

doi:10.1111/jcpt.12683

Cited by 14 publications

(19 citation statements)

References 16 publications

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“…First, there was no certainty that the reported event was actually due to the drug because confounding by concomitant medications and comorbidities is likely. Second, it is possible that the data involve a reporting bias, including the underreporting of adverse events, which is an inherent limitation of a voluntary reporting system like JADER and other pharmacovigilance databases …”

Section: Discussionmentioning

confidence: 99%

Association of Stevens‐Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs in pediatric patients: Subgroup analysis based on a Japanese spontaneous database

et al. 2019

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What is known and objective Antiepileptic drugs (AEDs) are known to cause Stevens‐Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which are severe cutaneous disorders; however, real‐world data remain limited, especially on pediatric patients. The objective of this study was to investigate the association of AEDs with SJS and TEN in pediatric patients based on the Japanese Adverse Drug Event Report (JADER) database, which is a spontaneous reporting database. Methods Adverse event reports submitted to the JADER database between 2004 and 2017 were analysed. We performed a retrospective pharmacovigilance disproportionality analysis, calculating the reporting odds ratio (ROR) with a 95% confidence interval (CI). Results and Discussion A total of 159 605 adverse events were reported in pediatric patients. Significant SJS signals were detected for ethosuximide, phenytoin, phenobarbital, gabapentin, carbamazepine, zonisamide, clonazepam and lamotrigine. TEN signals were detected for ethosuximide, phenytoin, phenobarbital, gabapentin, carbamazepine and zonisamide, but the signal was strongest for gabapentin (ROR, 24.76; 95% CI, 11.4‐53.9). What is new and conclusion Severe cutaneous disorders were associated with multiple AEDs, but individual AEDs were associated with variable signals. These results may be useful for minimizing the risk of SJS or TEN during treatment of children with AEDs.

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Section: Discussionmentioning

confidence: 99%

Association of Stevens‐Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs in pediatric patients: Subgroup analysis based on a Japanese spontaneous database

et al. 2019

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“…In Japan, this technique showed various adverse events associated with pregabalin in patients with cancer. 17 Using the US FDA Adverse Event Reporting System, pharmacovigilance analysis identified serious adverse events in patients with organ transplants. 18 In this study, cytomegalovirus infection, cytomegalovirus-positive, and polyomavirus-associated nephropathy were MMF-associated adverse events in adult renal transplant patients.…”

Section: Discussionmentioning

confidence: 99%

Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients

et al. 2018

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ObjectiveImmunosuppressive regimens after renal transplantation usually include a combination of calcineurin inhibitors, corticosteroids, and a proliferation inhibitor, either azathioprine or mycophenolate mofetil (MMF), to prevent rejection and maintain graft function. MMF has a stronger immunosuppressive effect than does azathioprine. This study aimed to examine MMF-associated adverse events in renal transplant patients.MethodsRetrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report database.ResultsA total of 11,594 adverse drug events were reported in renal transplant patients; 10,272 (88.6%) involved adults and 1322 (11.4%) involved children. In adult patients, the most frequent adverse events induced by MMF were cytomegalovirus infection (272 reports), urinary tract infection (69 reports), and polyomavirus-associated nephropathy (61 reports). Among adverse events, the highest reporting odds ratio (ROR) was found for cytomegalovirus infection (ROR, 1.58; 95% confidence interval, 1.36–1.83). In pediatric patients, the rank order for MMF-associated adverse events was cytomegalovirus infection (27 reports), bronchitis (23 reports), and cytomegalovirus viremia (19 reports), but these adverse events were not detected as a signal.ConclusionOur results show the safety profile of MMF in pediatric renal transplant patients. These findings can be used to update information used for prescriptions for pediatric patients.

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“…The regulatory authority in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA), has released the SRS for the Japanese Adverse Drug Event Report (JADER) database. In the JADER database, brief AE profiles, except for the detailed AEFs, associated with pregabalin in patients with or without cancer are recorded …”

Section: What Is Known and Objectivesmentioning

confidence: 99%

“…In the JADER database, brief AE profiles, except for the detailed AEFs, associated with pregabalin in patients with or without cancer are recorded. 17 The aim of this study was to obtain novel information on the onset profiles of AEFs and several clinical factor combinations such as age and administered dose, using the FAERS and JADER database.…”

Section: What Is K Nown and Objec Tive Smentioning

confidence: 99%

Evaluation of pregabalin-induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases

et al. 2018

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Summary What is known and objective Pregabalin is used for neuropathic and postherpetic pain and generalized anxiety. The aim of this study was to obtain the onset profiles of adverse events (AE) related to falls (AEFs) such as “somnolence,” “dizziness,” “loss of consciousness” and “fall” onset and several clinical factor combinations such as age and administered dose, using spontaneous reporting system (SRS) analysis such as the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database. Methods We used the reporting odds ratio (ROR) to analyse the association between pregabalin and AEFs. Additionally, we used the time‐to‐onset analysis. Results and discussion The crude RORs of AEFs such as somnolence and dizziness were higher than one for both the databases. The adjusted RORs for AEFs in the ≥60 years age group compared to those in the <60 years age group for the FAERS and JADER databases were 1.46 (95% CI = 1.39‐1.53; P < 0.0001) and 2.58 (95% CI = 2.06‐3.27; P < 0.0001), respectively. In the JADER database, the median and quartile range for AEFs with pregabalin, at ≤75 and ≥100 mg/d, were 2.0 (0.0‐5.0) and 2.0 (1.0‐4.3) days, respectively. Additionally, 57.2% of AEFs (four preferred terms) were observed within 2 days after administration. What is new and conclusions This study is the first to evaluate the relationship between pregabalin and AEFs using the SRS analysis strategy. The risk of AEFs in the ≥60 years age group might increase compared to that in the <60 years age group. AEFs occurred almost within 1 week after pregabalin administration, and the median for AEF onset was 2 days. Our results show that patients should be closely monitored for AEFs for 1 week from the start of pregabalin administration.

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Adverse drug event profile associated with pregabalin among patients with and without cancer: analysis of a spontaneous reporting database

Abstract: The ADE profiles of pregabalin were broadly similar among patients with and without cancer, but time-to-onset and type of some ADEs may be different.

Cited by 14 publications

References 16 publications

Association of Stevens‐Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs in pediatric patients: Subgroup analysis based on a Japanese spontaneous database

Association of Stevens‐Johnson syndrome and toxic epidermal necrolysis with antiepileptic drugs in pediatric patients: Subgroup analysis based on a Japanese spontaneous database

Differential profiles of adverse events associated with mycophenolate mofetil between adult and pediatric renal transplant patients

Evaluation of pregabalin-induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases

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