Danish Pharmacovigilance Update, 15 December 2011

03 January 2012
  • Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, front page
  • Increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), front page
  • Pradaxa® capsules are NOT to be opened, page 2
  • New recommendations for the antidepressant escitalopram, page 2
  • Tibolone and a potential risk of thromboembolisms, myocardial infarction, breast cancer and ovarian cancer, page 3
  • Rosuvastatin and the risk of gynaecomastia, page 3
  • In October, the Danish Medicines Agency received two reports involving cases of lactic acidosis in patients undergoing treatment with metformin for the treatment of type 2 diabetes, page 4
  • Consumption analysis of Daxas® for COPD patients with known depression, page 5
  • Childhood vaccinations and adverse reactions in the third quarter of 2011, page 6
  • Gender differences in adverse reaction reports, page 8
  • When is it important for doctors to report adverse reactions to the Danish Medicines Agency? Back page
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