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Author: Admin | 2025-04-28
An important post-hoc subset of subjects: The Proposed Label Population … is the Applicant’s proposed target population. The Applicant’s rationale for limiting use to this population is that it might be difficult for a physician to distinguish between a prior stroke and a prior TIA, and it would more prudent to simply exclude patients with either from treatment with vorapaxar because of the risk of intracranial hemorrhage.99FDA’s additional remarks on the need to exclude patients with prior stroke and the need to exclude patients with prior transient ischemic attack (TIA), took the form, “However, a warning against its use in anyone who has had a TIA may be justified if the drug is approved.”100As shown below, the label contraindicated the use of vorapaxar in patients with a history of stroke and also in patients with history of TIA.Package label. The package label for vorapaxar (Zontivity®) included a Black Box Warning and a Contraindications section, where both contraindicated use of vorapaxar in patients with history of stroke or history of TIA:WARNING: BLEEDING RISK … Do not use ZONTIVITY in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding … Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including intracranial hemorrhage (ICH) and fatal bleeding.101CONTRAINDICATIONS. History of stroke, TIA, or intracranial hemorrhage (ICH). Active pathological bleeding.102Read full chapterURL: https://www.sciencedirect.com/science/article/pii/B9780128146477000051ContraindicationsContraindications to arthroscopic trapeziometacarpal arthroplasty include any general contraindication to thumb arthroscopy, including distortion of the anatomy due to swelling, unstable or friable skin
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