Danish Pharmacovigilance Update, 20 September 2012

17 October 2012

In this issue of Danish Pharmacovigilance Update:

  • New definition of adverse reactions due to new European legislation on pharmacovigilance (front page)
  • Decline in the number of elderly people over 79 years of age receiving Pradaxa 150 mg (pp 2-3)
  • New recommendations for dosing, duration and precautions when treating patients with nosocomial (hospital-acquired) pneumonia with Doribax® (doripenem) (p 3)
  • Cases of symptomatic hypocalcaemia in patients undergoing treatment with Xgeva® (denosumab) (p 4)
  • Revatio (sildenafil) has been approved in the EU for the treatment of children, but should only be used in the recommended low doses (p 4)
  • Report of development of pulmonary fibrosis associated with the use of the active substance amiodarone (Cordan® and others) (p 5)

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