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Teriparatide-associated calciphylaxis: a case series.

J Kim¹, K Konkel², S C Jones²

¹Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. jenny.kim@fda.hhs.gov.

Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

|September 8, 2021

Summary

Teriparatide may trigger calciphylaxis, a rare vascular disease, in patients with risk factors. Early diagnosis and management are crucial for this potentially fatal condition.

Keywords:

Calciphylaxis Non-uremic Osteoporosis Teriparatide

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A Calcium Phosphate-Induced Mouse Abdominal Aortic Aneurysm Model

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Area of Science:

Vascular Medicine
Pharmacovigilance
Nephrology

Background:

Calciphylaxis is a rare, severe small-vessel disease affecting the vascular media, intima, and endothelium.
It commonly occurs in end-stage renal disease patients with hyperparathyroidism and high calcium-phosphorus levels.
The incidence of non-uremic calciphylaxis and its association with specific medications remain under-investigated.

Purpose of the Study:

To characterize cases of calciphylaxis potentially associated with teriparatide use.
To assess the incidence and clinical features of teriparatide-associated calciphylaxis.
To evaluate the role of risk factors in the development of calciphylaxis following teriparatide exposure.

Main Methods:

A systematic search of medical literature (PubMed, EMBASE) and FDA adverse event reports (AERS) was conducted up to March 31, 2021.
Cases of calciphylaxis within two years of teriparatide initiation were included.
Clinical data, including patient demographics, time to onset, risk factors, and outcomes, were analyzed.

Main Results:

Twelve cases of teriparatide-associated calciphylaxis were identified, with a median patient age of 81 years.
The median time from teriparatide initiation to calciphylaxis onset was 3.5 months.
All identified cases presented with multiple risk factors, including concomitant medications, female sex, and underlying inflammatory conditions. One case resulted in death.

Conclusions:

Teriparatide exposure, particularly in patients with pre-existing risk factors, may precipitate new-onset calciphylaxis.
Prompt clinical diagnosis and intervention are essential for managing this life-threatening condition and improving patient outcomes.