Medsafe group manager Dr Stewart Jessamine tells the court that because fluoxetine is not approved for major depressive disorder treatment in children and adolescents in New Zealand, the only way it can be given to that age group is by what's known as "off label" prescribing.
"This means informed consent must be obtained from the patient," he says.
Marinoto staff prescribing fluoxetine for Toran, in the two periods in 2007 and 2008 he was under their care, say informed consent was sought and, in the second instance, Toran asked to go back on the medication.
Both Toran and his mother were given information pamphlets which included information about side effects. Staff also say they discussed with Toran and his mother that the drug was not approved for those under 18 and that it carried a "Black Box" warning in the United States.
source - http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10623761
"This means informed consent must be obtained from the patient," he says.
Marinoto staff prescribing fluoxetine for Toran, in the two periods in 2007 and 2008 he was under their care, say informed consent was sought and, in the second instance, Toran asked to go back on the medication.
Both Toran and his mother were given information pamphlets which included information about side effects. Staff also say they discussed with Toran and his mother that the drug was not approved for those under 18 and that it carried a "Black Box" warning in the United States.
source - http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10623761
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