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Pulmonary oil microembolism and medication error: 28 case reports In a retrospective post-marketing safety analysis study of pulmonary oil microembolism (POME) reports from Endo Pharmaceuticals Inc. database between 5 March 2014 and 30 June 2018, 28 men including aged 33–75 years [not all ages stated] were described, who developed POME following treatment with testosterone-undecanoate for hypogonadism. Among these 28 patients, 4 patients developed POME secondary to medication error. The patients had a history of hypogonadism, for which they were registered under Aveed Risk Evaluation and Mitigation Strategy program. Under this program, the patients received IM testosterone-undecanoate [Aveed] 750 mg/3mL injection, which was injected into the gluteus medius muscle with a dosing schedule of baseline, week 4 and then every 10 weeks. However, following treatment with testosterone-undecanoate, the patients developed POME, which was manifested as cough, dyspnoea with or without other symptoms such as chest pain, throat irritation, malaise, hyperhidrosis, dizziness and paresthesia. Among the 28 patients, 4 patients had medication error, of whom, 3 patients were hospitalised for the management of POME. In these patients, the POME developed due to inappropriate injection technique as the health care professional did not follow prescribing information for administration. At the time of report, in 21 patients, the outcome of the POME event was reported as resolved, and 1 patient it was reported as not recovering. One patient had death unrelated to POME or testosterone-undecanoate treatment [not all time to reactions onsets and outcomes stated]. Pastuszak AW, et al. Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis. Sexual Medicine 8: 237-242, 803499646 No. 2, Jun 2020. Available from: URL: http://doi.org/10.1016/j.esxm.2020.01.009

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Reactions 5 Sep 2020 No. 1820