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Occurrence of pulmonary oil microembolism (POME) with intramuscular testosterone undecanoate injection: literature review

International Journal of Impotence Research volume 35, pages 439–446 (2023)Cite this article

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Abstract

Testosterone undecanoate injections (TU), an oil-based depot, is a universal hormonal-based treatment which has been associated with pulmonary oil microembolism (POME). However, the rate of POME during routine intramuscular (IM) TU injection is unknown. Here, we conduct a peer-reviewed literature review investigating POME incidents in the setting of TU injections. A total of 48 articles were selected in the literature review, which included 29 studies that used TU and reported its effects. Relatively few POME cases were reported across multiple published studies, including those that focused particularly on the occurrence rate of POME while administrating IM TU. Of the 29 individual studies, which included 7 978 patients, eight studies reported a total of 88 incidence of POME cases or cough. This included episodes of cough that were not originally declared as POME. One post market review reported 223 cases per 3,107,652 injections. When POME did occur, almost all cases resolved spontaneously within 60 min without intervention. Overall, POME was observed to be rare.

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Data availability

The data located in the table that support the findings of this study are available in References with the identifier(s) data DOI(s), title, and authors listed per references number listed. The “AVEED® (testosterone undecanoate) injection, for intramuscular use CIII” and data that support the findings of this study are openly available in/from FDA data access, https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022219s000lbl.pdf. The “AVEED® (testosterone undecanoate) for testosterone replacement for treatment of hypogogonadism” data that support the findings of this study are openly available in/from Joint Meeting of Reproductive Health Drug and Advisory Committee and Drug Safety Risk Management Advisory Committee, https://www.scribd.com/document/211471259/AVEED-Testosterone-Undecanoate-UCM348092.

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Author contributions

Conceived presented idea- AWP. Article written by JAA with support from AWP, MCB. Editor-JAA, AWP, MBC, RS. Interoperated results-JAA, AWP, MBC, RS. Literature review-JAA, AS. Supervised findings-AWP, MBC, JMH, LIL.

Funding

No external funds were received. Sources for references listed were through A.T. Still University, School of Osteopathic Medicine in Arizona library. Library access is granted to the University’s students.

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Authors and Affiliations

  1. Medical A.T. Still School of Osteopathic Medicine in Arizona, Mesa, AZ, USA

    Jarren A. Adam

  2. University of Utah School of Medicine, Salt Lake City, UT, USA

    Alexander W. Pastuszak & Michael B. Christensen

  3. University of Utah Hospital, Salt Lake City, UT, USA

    Rachel Spencer

  4. Juan Diego Catholic High School, Draper, UT, USA

    Ashlynn Sandberg

  5. University of Utah Hospital, Utah Center for Reproductive Medicine, Salt Lake City, UT, USA

    James M. Hotaling

  6. Baylor College of Medicine, Lester and Sue Smith Endowed Fund for Reproductive Medicine, Dan L Duncan Comprehensive Cancer Center, Houston, TX, USA

    Larry I. Lipshultz

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Correspondence to Jarren A. Adam or Alexander W. Pastuszak.

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Competing interests

AWP reports the following: Bayer AG–speaker.; Endo Pharmaceuticals, Inc.—speaker, advisor, consultant, research/fellowship support. Antares Pharmaceuticals—advisor; Inherent Biosciences—advisor; Allotrope Medical—advisor; Woven Health—founder and leadership position; Vault Health—leadership position. MBC: Vault Health—Consultant.

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Adam, J.A., Pastuszak, A.W., Christensen, M.B. et al. Occurrence of pulmonary oil microembolism (POME) with intramuscular testosterone undecanoate injection: literature review. Int J Impot Res 35, 439–446 (2023). https://doi.org/10.1038/s41443-022-00585-1

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