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15 March 2012 | Updated 16 March 2012 /Side effects and trials
New data on antidepressants of the SSRI type and prevalence of malformations in newborns
Data from a large Danish registry study launched by the Danish National Board of Health suggest that the risk of malformations in children is slightly increased in women who were treated in early pregnancy with an antidepressant of the type selective serotonin reuptake inhibitors (SSRIs). The Danish National Board of Health maintains its recommendation that the decision to medically treat depression in pregnant women should be made only in consultation with a specialist in psychiatry and after other non-medical options have been considered.
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01 March 2012 /Side effects and trials
EMA has updated its questions and answers about GCP
In certain types of trial designs, the investigator and patient do not know whether the patient receives a placebo drug (inactive substance) or a medicine containing an active substance. But in some situations, the investigator needs to know what the patient has been given, in which case it should be possible for the investigator to break the blinding. The new question from EMA deals with whether or not the investigator is to contact the sponsor before he or she breaks the blinding for a patient in a trial.
