Danish Pharmacovigilance Update, February 2016

09 March 2016

News from the EU

  • SGLT2 (sodium-glucose co-transporter 2) inhibitors and development of life-threatening atypical ketoacidosis in patients with type 2 diabetes, page 2
  • New recommendations to minimise the risk of PML in connection with treatment with natalizumab (Tysabri), page 3
  • EU's list of recommendations on safety signals, page 4

News from the Danish Medicines Agency

  • Special focus on reported adverse reactions to biological medicines and biosimilars, page 5
  • Development in the number of melatonin users younger than 25 years of age from 2007-2015, page 12
  • Beware of interactions between miconazole and warfarin – new, serious ADR reports, page 14

Short news

  • Most recent Direct Healthcare Professional Communications (DHPCs), page 15


Danish Pharmacovigilance Update, February 2016