Danish Pharmacovigilance Update, 17 January 2013

26 March 2013

In this issue of Danish Pharmacovigilance Update:

  • The Pharmacovigilance Risk Assessment Committee, PRAC, finds that the risks outweigh the benefits from the use of Tredaptive® (front page)
  • Information to doctors concerning the correct use of the approved dosing regimen for bivalirudin (Angiox®) in percutaneous coronary intervention (p 2)
  • New recommendations for the use of the tissue adhesives Tisseel®, Tissucol®, Artiss® and Beriplast® (p 3)
  • Monovalent and multivalent vaccines against measles, mumps, German measles (rubella) (MMR) and/or chickenpox (varicella) (MMRV) should continue to be avoided during pregnancy and in patients with a weakened immune system (p 4)
  • Reports of adverse reactions comprising hearing loss and memory problems in association with the use of tadalafil (Cialis®) (p 5)
  • The Danish Health and Medicines Authority has prepared a new status report for Pradaxa® (dabigatran etexilate) and Xarelto® (rivaroxaban) (p 5)
  • The most frequent drugs in adverse reaction reports concerning children/foetuses are nervous system drugs (ATC group N) (pp 6-9)