Danish Pharmacovigilance Update, March 2016

25 April 2016

News from the EU

  • Inhaled corticosteroids and risk of pneumonia in COPD patients, page 2
  • The European Pharmacovigilance Risk Assessment Committee is reviewing gadolinium contrast agents, page 3
  • Updated precautions for use of idelalisib (Zydelig), page 3
  • EU's list of recommendations on safety signals, page 4

News from the Danish Medicines Agency

  • Childhood vaccinations and reported suspected adverse reactions in Q4 of 2015, page 5
  • Reports of granuloma formation after vaccination with aluminium adjuvant vaccines, page 15
  • Lithium intoxication, page 18
  • Hypotonic solutions for infusion may cause hyponatraemia with severe cerebral symptoms, page 19
  • NSAIDs should be avoided in patients at risk of heart disease, page 20
  • Pregabalin and abuse potential, page 21

Short news

  • List of biological medicines and biosimilars, page 23
  • The DKMA’s annual pharmacovigilance report 2015, page 23
  • Most recent Direct Healthcare Professional Communications (DHPCs), page 23
  • Head of Pharmacovigilance and Editor-in-Chief signs off, page 24


Danish Pharmacovigilance Update March 2016