Background

Possible biases in pharmacovigilance reporting may impact Epidermal Necrolysis (EN) and drugs associations.

Objectives

To assess biases associated with EN reporting

Methods

Using Vigibase, the WHO-pharmacovigilance database, among drugs associated with EN between 2016 and 2020, we used an unsupervised clustering including reports characteristics, i.e. reporter quality, time from drug intake to EN onset and only one suspected drug in the report.

Results

Among 152 drugs, three clusters were identified. Cluster 1 (n=41) exhibited drugs frequently reported within a time from intake to onset longer than four days, in 57±13% of reports. It corresponded to well reported drugs and was composed mainly of antivirals and antiepileptics. Cluster 2 (n=42) exhibited drugs frequently reported within a time from drug intake to onset shorter than four days, in 31±12% of reports. It corresponded to drugs with a high risk of protopathic bias and was composed of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), analgesics and antibiotics. Cluster 3 (n=69) exhibited drugs frequently reported with an unvailable time from drug intake to reaction, in 66±11% of reports, and reported by a high frequency of consumers (9±9%). It corresponded to drugs reported with a high risk of classification bias, and was composed of anticancer therapies and cardiovascular drugs.

Conclusion

Protopathic and classification biases impact EN reporting and should be considered regarding associations with antibiotics, NSAIDs, analgesics, anticancer therapies and cardiovascular drugs.

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