Testosterone-containing medicines associated with risk of VTE
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Testosterone-containing medicines associated with risk of VTE Certain testosterone-containing medicines should be used with caution in patients with risk factors for venous thromboembolism (VTE), says Ireland’s HPRA.* Following a recent periodic review of topical, oral and injectable formulations of testosterone-containing medicines, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that product information for these medicines should be updated. The HPRA has indicated that brand names of testosterone-containing medicines licensed in Ireland include Androgel, Nebido, Restandol Testocaps, Testarzon, Testim, Testogel and Tostran. A review of the scientific literature (including two studies lead by Dr Charles J. Glueck and his colleagues, both published in 2018) resulted in the PRAC recommending that existing product information (i.e. Summary of Product Characteristics, and Package Leaflet) for testosterone-containing medicines should be amended to highlight the need to use these products with caution in patients with risk factors for VTE. In addition, cases of VTE have been reported in patients with thrombophilia – including in some patients who are also taking anticoagulants. The HPRA has advised healthcare professionals that "continuing testosterone treatment in patients with thrombophilia requires careful evaluation after a first thrombotic event and implementation of measures to minimise the individual VTE risk". Consequently, a similar warning will be included to the appropriate product information, and the HPRA said that "the PRAC considered it pertinent to specify risk factors for VTE in the Package Leaflet and additionally to include signs and symptoms of thrombosis in order to highlight these for patients". All reports of suspected adverse reactions with testosterone-containing medicines should be reported to the HPRA via the available methods. * HPRA = Health Products Regulatory Agency Health Products Regulatory Authority. Testosterone-containing medicinal products - Caution in patients with thrombophilia or risk factors for venous thromboembolism 803499206 (VTE). Internet Document : 17 Aug 2020. Available from: URL: https://www.hpra.ie/docs/default-source/default-document-library
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Reactions 29 Aug 2020 No. 1819
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