Drug‐induced sarcoidosis: an overview of the WHO pharmacovigilance database

Background There is a documented association between drug exposure and sarcoidosis‐like reactions. In this study, we used the largest pharmacovigilance database to describe drug‐induced sarcoidosis. Methods Data were collected from the World Health Organization (WHO) pharmacovigilance database (VigiBase). We excluded steroids and vaccines from the analysis. The primary end‐point was the lower end‐point of the 95% credibility interval for the information component (IC025). Results A total of 127 reports had significant IC025 values for drug‐induced sarcoidosis, and 110 were included in the final analysis, accounting for 2425 adverse drug reactions. Overall, 2074 (85.5%) reactions were considered ‘serious’ and 86 (3.5%) were fatal. Most of the drugs that led to sarcoidosis adverse reactions were TNF‐alpha antagonists, interferon or peg‐interferon therapeutics, and immune checkpoint inhibitors. Other biologic drugs were less frequently associated with sarcoidosis adverse events. Cancer‐targeted therapies such as BRAF or MEK inhibitors were associated with sarcoidosis reactions in 37 cases. Pulmonary hypertension drugs were also reported for drug‐induced sarcoidosis. Amongst the 55 drugs considered as potential sarcoidosis inducers, 25 (45.4%) were never reported in Medline as drug‐induced sarcoidosis. Conclusions We provide a detailed list of suspected drugs associated with drug‐induced sarcoidosis that will improve the recognition of this drug‐induced adverse event.