Study summary · research use only
Teriparatide-associated calciphylaxis: a case series
Plain-language summary
Paraphrased from the published abstract below — not a verdict on whether anything works.
This case series reviewed postmarketing adverse event reports of teriparatide-associated calciphylaxis in humans, searching the literature (EMBASE, PubMed) and FDA reports through March 31, 2021, for cases following teriparatide exposure of less than 2 years. Twelve cases were identified, median age 81 (range 47-86) years; eleven had confirmatory biopsy and/or imaging. Median time-to-onset after teriparatide initiation was 3.5 (range 1-20) months. Three cases involved hospitalization, one resulting in death from progression of the lesions. All cases had multiple risk factors (mean 4.5), including concomitant medications associated with calciphylaxis (12 cases), female sex (11 cases), and underlying autoimmune or other inflammatory disorders (10 cases). The authors state teriparatide exposure, combined with underlying risk factors, may have triggered new-onset calciphylaxis in these cases.
Abstract
Calciphylaxis is a rare and potentially fatal small-vessel occlusive disease in which the tunica media becomes calcified, endothelial cells proliferate, and the tunica intima becomes thickened and fibrotic. Calciphylaxis typically occurs in the setting of end-stage renal disease with secondary hyperparathyroidism and elevated calcium-phosphorus product. The estimated incidence of calciphylaxis in dialysis or kidney transplant patients is 1 to 4%; however, the incidence of non-uremic calciphylaxis is unknown. We assessed postmarketing adverse event reports to further characterize cases of calciphylaxis associated with teriparatide. We searched for cases of teriparatide-associated calciphylaxis in the literature (EMBASE, PubMed) and those reported to FDA, including the FDA Adverse Event Reporting System, through March 31, 2021. We included calciphylaxis cases following teriparatide exposure of < 2 years. Twelve cases described teriparatide-associated calciphylaxis. The median age was 81 (range 47-86) years. Eleven cases reported confirmatory biopsy and/or imaging. The median time-to-onset of calciphylaxis following teriparatide initiation was 3.5 (range 1-20) months. Three cases reported hospitalization, of which one resulted in death due to progression of the lesions. All cases had multiple risk factors (mean (SD), 4.5 (1.0)) including concomitant medications associated with calciphylaxis (12), female sex (11), and/or underlying autoimmune disease or other inflammatory disorder (10). We believe that exposure to teriparatide, coupled with underlying risk factors, may have triggered new-onset calciphylaxis. Expedited diagnosis and management by a clinician are important because calciphylaxis may be life-threatening and early intervention may improve outcomes.
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