Abstract
The use of steroid compounds formulated in oil for depot injection can be associated with acute pulmonary reactions characterized primarily by cough, but sometimes with other associated symptoms. The pathophysiology of these reactions remains unclear, although they are reported in the literature as ‘POMEs’ or pulmonary oil micro-embolism events. We report on a large case series and propose a case definition for these events. These events can raise significant concern even though they are often self-limited. It is hoped that clinicians will recognize these events more readily and be able to inform patients better, and that future reports and assessments can benefit from our proposed case definition.
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Declaration of funding
This study was not funded. The authors wrote this study report independently without support of any kind from Endo Pharmaceuticals.
Declaration of financial/other relationships
R.J.M. and M.M. have disclosed that they served as paid regulatory consultants to Endo Pharmaceuticals to adjudicate POME cases from the controlled and post-marketing clinical experience with testosterone undecanoate for intramuscular injection.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Notes
*Aveed is a registered trade name of Endo Pharmaceuticals (499 South Capital Street, South Washington, DC, USA)
†Nebido is a registered trade name of Bayer Pharmaceuticals (Bayer AG, 51368 Leverkusen, Germany)