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  • 28 October 2011 /Side effects and trials

    European Medicines Agency recommends lower dose of citalopram

    In October 2011, the European Pharmacovigilance Working Party has concluded to reduce the maximum dose of the antidepressant medicine citalopram. The recommendation follows from a drug trial and adverse reactions showing that citalopram may affect the heart rhythm, especially when given in high doses.

  • 25 October 2011 /Side effects and trials

    Number of suspected adverse reactions reported to the Danish Medicines Agency for articaine

    In 2006, the Danish Medicines Agency examined the risk of nerve damage from the anaesthetics that dentists use for local anaesthesia. The examination was initiated due to a suspicion raised in Denmark that one of the active substances, articaine, caused a greater risk of nerve damage than other substances. We have followed the development since then, and we have decided to review the safety again.

  • 24 October 2011 /Side effects and trials

    Adverse reaction reports on antidepressants and pregnancy – June to October 2011

    On 20 September 2011, the Danish Medicines Agency published an overview report (in Danish) on antidepressants of the SSRI type, the main focus being on safety and the risk of adverse reactions in foetuses and newborns whose mothers had taken an SSRI. In the subsequent period from 14 June 2011 to 9 October 2011, the Danish Medicines Agency has received 12 reports concerning 21 suspected adverse reactions in children/foetuses whose mothers had taken an SSRI.

  • 04 October 2011 /Side effects and trials

    Monthly report from the EU Pharmacovigilance Working Party, PhVWP – September 2011

    The EU Pharmacovigilance Working Party (PhVWP) convened on 19-21 September. On the meeting's agenda was: active substances with a known risk of Stevens-Johnson syndrome and toxic epidermal necrolysis.

  • 04 October 2011 /Side effects and trials

    Monthly reports from the EU Pharmacovigilance Working Party, PhVWP – June and July 2011

    The EU Pharmacovigilance Working Party (PhVWP) convened on 20-22 June and 18- 20 July 2011.