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