27 September 2011 /Side effects and trials
Based on a debate about the safety of treatment with SSRI antidepressants, the Danish Medicines Agency has drawn up an overview report. The report aims to provide healthcare professionals and others involved in SSRI treatment with an overview of our current knowledge about the consumption of SSRIs and the safety of this type of medicine. The main focus of the report is on the safety of SSRIs and the risk of adverse reactions in foetuses and newborns of mothers who have used SSRI antidepressants.
23 September 2011 /Side effects and trials
The European Medicines Agency, EMA, recommends limited use of the medicine Multaq®, which is used for cardiac arrhythmia. This is the result of an overall review of the risks and benefits of this medicine carried out by the Committee for Medicinal Products for Human Use, CHMP. The review was initiated in January 2011 due to reports of serious liver damage in patients who had been treated with Multaq®.
13 September 2011 /Side effects and trials
The U.S. Food and Drug Administration (FDA) recently issued a warning against using large doses of the antidepressant citalopram. The FDA has reviewed data which shows that doses of citalopram of 60 mg a day may be linked with changes in the heart rate (QT interval prolongation).
08 September 2011 /Side effects and trials
The Danish Medicines Agency now launches an e-form in English for reporting suspected unexpected serious adverse reactions in clinical trials (SUSARs). The e-form specifically targets researchers and small and medium-sized enterprises that for some reason cannot report via EudraVigilance.