Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Xarelto for Extended Treatment of VTE

Bayer news release; ePub 2017 Oct 30

The US Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) for the extended treatment of venous thromboembolism (VTE), following at least 6 months of standard anticoagulation therapy.

Indications: Xarelto is a factor Xa inhibitor indicated for the reduction in the risk of recurrence of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months (label update).

Dosage/administration: 10 mg once daily with or without food, after at least 6 months of standard anticoagulation treatment.

Adverse reactions: The most common adverse reaction (>5%) was bleeding.

Citation:

Bayer receives FDA approval for Xarelto 10 mg once daily for the extended treatment of venous thromboembolism. [news release]. Berlin, Germany: Bayer; October 30, 2017. http://press.bayer.com/baynews/baynews.nsf/id/4DCD2EFF25773D4FC12581C600...$File/2017-0293E.pdf?open&mod=30.10.2017_12:54:03. Accessed November 12, 2017.

This Week's Must Reads

Total & CV Mortality After LDL-C Lowering, JAMA; 2018 Apr 17; Navarese, et al

PCSK9 Inhibitors for Tx of Hypercholesterolemia, Ann Pharmacother; ePub 2018 Apr 1; Patel, et al

High-Intensity Statin Use and LDL-C Control, J Clin Lipidol; ePub 2018 Apr 26; Lamprecht Jr, et al

Improving Adherence with ASCVD Interventions, Clin Cardiol; ePub 2018 Apr 17; Fentanes, et al

Lipid Screening in Children with NAFLD, J Pediatr; ePub 2018 Apr 13; Harlow, et al

Must Reads in FDA Actions

FDA Approves Giapreza for Treatment of Low BP, FDA news release; ePub 2017 Dec 21

FDA Approves EKG Device for Apple Watch, AliveCor news release; 2017 Nov 30

FDA Approves Expanded Indication for Tekturna, Noden Pharma news release; 2017 Nov 14

FDA Approves Xarelto for Extended Treatment of VTE, Bayer news release; ePub 2017 Oct 30

HeartWare HVAD System OK’d for Destination Therapy, Medtronic news release; 2017 Sep 27