Danish Pharmacovigilance Update, April 2015

08 May 2015

The April issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news:

News from the EU

  • High-dose ibuprofen/dexibuprofen may cause small increased cardiovascular risk, page 2
  • EU recommends further measures to minimise risk of osteonecrosis of the jaw with zoledronic acid and denosumab, page 3
  • EU's list of recommendations on safety signals, page 4

News from the DHMA

  • Warfarin Orion must not replace Marevan and Waran, page 5
  • Clozapine and reports of deaths, page 6
  • Aubagio® under strict monitoring, page 9
  • Influenza vaccines and reports of suspected adverse reactions, page 13

Short news

  • Most recent Direct Healthcare Professional Communications (DHPCs), page 16
  • Danish Health and Medicines Authority's Annual Pharmacovigilance Report 2014, page 16


Danish Pharmacovigilance Update April 2015