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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.
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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.
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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.
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12 October 2011 /Side effects and trials
Focus on medicines most frequently involved in serious adverse drug events can improve patient safety
A new study carried out by a working group associated with the Danish Medicines Agency's network "Prevention of Medication Errors" has shown that it is more or less the same groups of medicines that have been involved in the so-called adverse events from the 1970s and up until today. Based on the study, we have drawn up two lists of medicines that appear in high-risk situations – sorted by active substance and medicine group. The Danish Medicines Agency and the working group behind the study hope that these lists can become an important tool in the daily work with risks in the medication process in the health sector.
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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.
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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.
