Skip to main content

ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1391356

Indications and adverse events of Teriparatide: based on FDA adverse event reporting system (FAERS)

Provisionally accepted
Mingtao Wen Mingtao Wen 1Jiacheng LEE Jiacheng LEE 2Bowen Lu Bowen Lu 2*Huarong Shao Huarong Shao 3*Peixue Ling Peixue Ling 3*Fei Liu Fei Liu 3*Gang Li Gang Li 2*Di Luo Di Luo 4*
  • 1 Shandong University of Traditional Chinese Medicine, Jinan, China
  • 2 First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China
  • 3 Shandong Academy of Pharmaceutical Sciences, Jinan, Shandong Province, China
  • 4 Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China

The final, formatted version of the article will be published soon.

    Background: Teriparatide is approved for osteoporosis. Post-marketing surveillance is critical given its widespread use.Objective: To investigate adverse events (AEs) associated with teriparatide using the FAERS database, compare association strengths for key AEs, and explore potential applications to provide clinical reference. Methods: FAERS data from 2004 to 2023 were analyzed. Reports where teriparatide was the primary suspect drug were included. Adverse events were mapped to System Organ Classes and Preferred Terms.Disproportionality analysis using ROR, PRR, BCPNN and EBGM algorithms was conducted to detect safety signals.Results: 107,123 reports of teriparatide as primary suspect drug were analyzed. Key AEs included pain in extremity (PRR:4.54), muscle spasms (PRR:5.11), fractures (PRR range: 17.67-552.95), increased calcium (PRR:50.73) and heart rate (PRR:3.4). Teriparatide exhibited higher strength for increased calcium (PRR:50.73) than fractures ). We identified off-label use in arthritis (0.57%) and cancer (0.12%). For osteoporosis, main AEs were pain (18.2%), fractures (12.4%), muscle spasms (7.7%) and nausea (6.5%), while for glucocorticoid-induced osteoporosis, AEs included fractures (24.1%), pain (13.2%), decreased bone density (9.8%) and nausea (5.1%).Our analysis provides real-world safety data on teriparatide. Findings reveal key AEs, compare association strengths, highlight off-label use, and deliver insights into different indications. Ongoing vigilance and research are critical to guide teriparatide's clinical use.

    Keywords: Teriparatide, Osteoporosis, FAERS, adverse events, Pharmacovigilance

    Received: 25 Feb 2024; Accepted: 23 Jul 2024.

    Copyright: © 2024 Wen, LEE, Lu, Shao, Ling, Liu, Li and Luo. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Bowen Lu, First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China
    Huarong Shao, Shandong Academy of Pharmaceutical Sciences, Jinan, Shandong Province, China
    Peixue Ling, Shandong Academy of Pharmaceutical Sciences, Jinan, Shandong Province, China
    Fei Liu, Shandong Academy of Pharmaceutical Sciences, Jinan, Shandong Province, China
    Gang Li, First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China
    Di Luo, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, Shandong Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.