Danish Pharmacovigilance Update, March 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

Link

Danish Pharmacovigilance Update March 2016