Characteristic analysis of adverse reactions of five anti-TNFɑ agents: a descriptive analysis from WHO-VigiAccess
Frontiers in Pharmacology · 5 authors, 2 centres
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This study analyzed adverse event reports for five anti-TNFα inhibitors from the WHO-VigiAccess database. The most commonly reported adverse reactions were non-specific symptoms like rash, arthralgia, and headache, while serious events like cancer were rarely reported.
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Key findings included that 70% of reports originated from the Americas and Europe, and adverse events were more commonly reported in females and the 45-64 age group, likely reflecting the patient population with rheumatoid arthritis. The most common reported adverse reactions were non-specific and often self-limiting, such as rash, arthralgia, headache, nausea, and pruritus. The study notes important limitations inherent to spontaneous reporting systems, such as voluntary reporting, potential for under-reporting, and lack of complete data, which can lead to underestimation of true incidence and preclude definitive causal conclusions.