Increased risk of cardiac arrest associated with the use of TCA and SSRI antidepressants

A new Danish study has found an increased risk of cardiac arrest associated with treatment with TCAs (tricyclic antidepressants) or SSRIs (selective serotonin reuptake inhibitors). The study found no association between increased risk of cardiac arrest and the use of SNRI antidepressants (serotonin and norepinephrine reuptake inhibitors) or NaSSA antidepressants (noradrenergic and specific serotonergic antidepressants).

Pradaxa – consider age and follow dose recommendations

In March, in collaboration with the Thrombosis Centre in Aalborg, the Danish Health and Medicines Authority published an evaluation of all adverse reaction reports in Danish Pharmacovigilance Update for the period 22 August 2011 up to and including 23 February 2012 in connection with a new indication (prevention of apoplexy in patients with non-valvular atrial fibrillation) for Pradaxa® (dabigatran etexilate). With this announcement, we once more want to call attention to the development in consumption, reported adverse reactions, age and dose recommendations.

Announcement of time slots for decentralised procedures in 2013

The Danish Health and Medicines Authority is closed on Ascension Day and Friday 18 May

Questions and answers from the Clinical Trial Facilitation Group on trial designs and DSUR