Thromb Haemost 2016; 115(05): 911-912
DOI: 10.1160/TH16-02-0124
Current Controversies
Schattauer GmbH

Diplopia on vorapaxar: An unexpected side effect emerging only at second glance

Lisa Gross
1   Medizinische Klinik und Poliklinik I, Klinikum der Universit⃤t M⃼nchen, Ludwig-Maximilians-Universit⃤t M⃼nchen, Munich, Germany
,
Dirk Sibbing
2   DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
› Author Affiliations
Further Information

Publication History

Received: 15 February 2016

Accepted: 15 February 2016

Publication Date:
06 December 2017 (online)

 

 
  • References

  • 1 Roffi M, Patrono C, Collet JP. et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2016; 37: 267-315.
  • 2 Tricoci P, Huang Z, Held C. et al. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med 2012; 366: 20-33.
  • 3 Morrow DA, Braunwald E, Bonaca MP. et al. Vorapaxar in the secondary prevention of atherothrombotic events. N Engl J Med 2012; 366: 1404-1413.
  • 4 Serebruany VL, Rao S, Tanguay J. et al. Vorapaxar and diplopia: Possible off-target PAR-receptor mismodulation. Thromb Haemost 2016; 115: 905-910.
  • 5 Baker NC, Lipinski MJ, Lhermusier T. et al. Overview of the 2014 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting about vorapaxar. Circulation 2014; 130: 1287-1294.
  • 6 NDA294–886. Cross-discipline Team Leader review on Vorapaxar. April 8th, 2014. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204886Orig1s000SumR.pdf Accessed February 10, 2016.
  • 7 Serebruany VL, Choi SY, Kim MH. The FDA review on data quality and conduct in vorapaxar trials: Much better than in PLATO, but still not perfect. Int J Cardiol 2016; 205: 13-16.
  • 8 Serebruany VL, Cherepanov V, Cabrera-Fuentes HA. et al. Solid cancers after antiplatelet therapy: Confirmations, controversies, and challenges. Thromb Haemost 2015; 114: 1104-1112.
  • 9 Serebruany V, Cherepanov V, Dukhanin A. Significant excess of early deaths after prehospital ticagrelor: The ATLANTIC trial challenge. Thromb Haemost 2015; 114: 7-8.
  • 10 Serebruany VL, Pokov AN, Fortmann SD. et al. Disbalance between mortality and non-fatal vascular events in the CHAMPION-PHOENIX trial: the cangrelor efficacy challenge. Thromb Haemost 2014; 111: 3-7.
  • 11 Fraunfelder FW, Richards AB. Diplopia, blepharoptosis, and ophthalmoplegia and 3-hydroxy- 3-methyl-glutaryl-CoA reductase inhibitor use. Ophthalmology 2008; 115: 2282-2285.
  • 12 Penedones A, Mendes D, Alves C. et al. Drug-induced ocular adverse reactions: review of the safety alerts issued during the last decade. J Ocul Pharmacol Ther 2015; 31: 258-268.
  • 13 Simonsen CZ, Nielsen E. Hypertensive microbleed as a transient ischemic attack mimic. Case Rep Neurol 2013; 5: 31-33.
  • 14 Mukhi SV, Lincoln CM. MRI in the Evaluation of Acute Visual Syndromes. Top Magn Reson Imaging 2015; 24: 309-324.
  • 15 Becker RC, Moliterno DJ, Jennings LK. et al. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebocontrolled phase II study. Lancet 2009; 373: 919-928.
  • 16 Goto S, Yamaguchi T, Ikeda Y. et al. Safety and exploratory efficacy of the novel thrombin receptor (PAR-1) antagonist SCH530348 for non-ST-segment elevation acute coronary syndrome. J Atheroscler Thromb 2010; 17: 156-164.
  • 17 Lasser KE, Allen PD, Woolhandler SJ. et al. Timing of new black box warnings and withdrawals for prescription medications. J Am Med Assoc 2002; 287: 2215-2220.