Headache associated with use of etanercept
The Netherlands Pharmacovigilance Centre Lareb received 39 reports of headache associated with the use of etanercept. Etanercept is used for different rheumatic diseases and psoriasis. In the Dutch patient leaflet of etanercept, headache is only described in children with juvenile idiopathic arthritis.
Headache associated with etanercept was reported in the spontaneous reporting system and also in the Biologic Monitor, a longitudinal observational cohort study using the Lareb Intensive Monitoring (LIM) system. In 16 reports the occurrence of the headache was related to the moment of administration of etanercept. In 13 of these reports the headache occurred shortly after administration. In 8 reports, headache recurred after each administration. Most patients recovered from the headache after a few days. In one report the patient did not recover and the intensity of the headache increased after each administration.
Lareb informed the Dutch Medicines Evaluation Board about these reports. The Dutch Medicines Evaluation Board will discuss this association within the European regulatory network.
Read the analysis of the reports.
Read more about the Biologic Monitor: Patients with inflammatory rheumatic diseases: quality of self-reported medical information in a prospective cohort event monitoring system.