Severe cutaneous adverse reactions to anti-osteoporosis drugs: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System database and a review of published cases.

OBJECTIVE

This study analyzed severe cutaneous adverse reactions (SCARs) linked to anti-osteoporosis drugs using FDA Adverse Event Reporting System (FAERS) data and characterized implicated drugs and clinical features through a literature review.

METHODS

A retrospective disproportionality analysis of SCAR reports from FAERS (2004-2024) utilized signal detection metrics, including reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN). A structured literature search across PubMed, Web of Science, and Scopus gathered case reports of SCARs induced by anti-osteoporosis drugs.

RESULTS

Of 77,789 SCAR reports, 399 (0.51%) involved anti-osteoporosis drugs, mainly affecting female patients (76.25%) with a median age of 69 years. Denosumab (24%), alendronate (23.25%), and zoledronic acid (17.13%) were most frequently reported. Significant signals included risedronic acid with erythema multiforme [ROR = 9.06; PRR = 9.03; information component (IC) = 3.17], zoledronic acid with cutaneous vasculitis (ROR = 3.15; PRR = 3.15; IC = 1.65), and alendronic acid with Stevens-Johnson syndrome (SJS) (ROR = 4.03; PRR = 4.02; IC = 2.00). The literature review (33 cases) confirmed a median symptom onset of 22 days, with treatments often involving corticosteroids and supportive care.

CONCLUSION

Anti-osteoporosis drugs, notably bisphosphonates and strontium ranelate, are rarely linked to SCARs but may cause serious consequences. Increased clinical awareness, pre-treatment risk evaluation, and vigilant monitoring are essential for at-risk patients.