Danish Pharmacovigilance Update, 19 April 2012

04 July 2012

In this issue of Danish Pharmacovigilance Update:

  • Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women (front page)
  • Risk of overdose of intravenous paracetamol (Perfalgan®) (p 2)
  • Proton-pump inhibitors and the risk of bone fracture (p 3)
  • Premature detachment of the placenta (abruptio placentae) and Zymelin® (p 4)
  • Animal data on SSRIs and reduced sperm quality (p 4)
  • New contraindications and warnings for the use of Protelos® in the treatment of postmenopausal osteoporosis (p 5)
  • Mesalazine (Asacol®, Pentasa®) for the treatment of ulcerative colitis, Crohn’s disease and renal impairment (p 6)
  • Strengthened warning against the risk associated with over-rapid increase in serum sodium in patients treated with tolvaptan (Samsca®) (p 7)
  • Risk of potential leaks with 5 l Physioneal Clear-Flex bags for patients on dialysis (p 7)
  • Annual pharmacovigilance report 2011 (p 8)
  • Focus on medical treatment of elderly people (pp 9-14)

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