Danish Pharmacovigilance Update, 27 June 2013

24 July 2013

In this issue of Danish Pharmacovigilance Update:

  • The benefits of medicines for the treatment of acne (Diane® Mite and others) continue to outweigh the risks of use within the indication (front page)
  • The EMA recommends restrictions in the use of retigabine (Trobalt®) (p 2)
  • Thiazides and hyponatraemia – reports to the Capital Region of Denmark's Adverse Drug Reaction Manager at the Department of Clinical Pharmacology at Bispebjerg Hospital (p 3)
  • ADR reports to the Danish Health and Medicines Authority concerning hyponatraemia from the use of thiazides (p 4)
  • Acute pancreatitis and hepatitis associated with the use of vildagliptin (Galvus®) and linagliptin (Trajenta®) reported as potential adverse reactions (p 5)
  • Reports of adverse reactions from the use of Gardasil® during the period 2009-2012 (pp 6-11)
  • New report from the Danish Health and Medicines Authority on the consumption of and adverse reactions from immunomodulatory biological drugs (p 12)