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Danish Pharmacovigilance Update 19 December 2013

17 February 2014

In this issue of Danish Pharmacovigilance Update:

News from the EU

  • Restrictions on the use of metoclopramide (Primperan® etc.) for the treatment of nausea and vomiting
  • Letters of safety information sent to doctors

News from the Danish Health and Medicines Authority

  • Patients with mechanical heart valves should not be treated with the new oral anticoagulants Pradaxa®, Xarelto® and Eliquis®
  • Stricter reporting requirements for suspected adverse reactions following vaccination with Infanrix hexa®
  • Childhood vaccinations and reported suspected adverse reactions during the first half of 2013
  • Desmopressin and hyponatraemia
  • The Danish Health and Medicines Authority's analysis of melatonin users under the age of 25

Short news

  • New opportunity to report adverse reactions from dietary supplements to the Danish Veterinary and Food Administration
  • Clarification to the article 'Bisphosphonates/denosumab and the risk of osteonecrosis of the jaw' in Danish Pharmacovigilance Update, 28 November 2013