The advisory was based on an discernment of data from 24 short-term, placebo-controlled trials of nine antidepressant drugs, including selective serotonin reuptake inhibitors (SSRIs), and involving 4,400 children and adolescents beingness treated for substance dry land depressive shape (MDD), obsessive-compulsive premise (OCD), and other psychiatric disorders.
Results showed an increased risk of suicidality (suicidal thoughts and/or behavior) in the care groups compared with medicament (4% vs 2%).
The FDA advises that the risk of increased suicidality be considered with variety meat to clinical need before initiating antidepressant therapy in children and adolescents with MDD and other psychiatric disorders, and that prescriptions be written for the lowest applicant thought of tablets to reduce the risk of overdose.
Families and caregivers should closely observe pediatric patients world treated with antidepressants for signs of clinical decay, suicidality, change, excitableness, and unusual changes in demeanor, especially during the low few months after start of therapy and upon dosing changes.
The new antidepressant labeling will include a averment regarding its approved pediatric indication(s).
Of the antidepressants, only fluoxetine (Prozac) is approved for use in treating MDD in pediatric patients. Fluoxetine, sertraline (Zoloft), fluvoxamine (Luvox), and clomipramene (Anafranil) are approved for OCD in pediatric patients.
None of the drugs is approved for other psychiatric indications in children.
The FDA notes that these labeling changes apply to the entire people of antidepressants due to a lack of available data to exclude any given drug from the associated increased risk of suicidality.
This is a part of article Daily monitoring and last lens with the prescribing physician are advised. Taken from "Prozac Fluoxetine Generic" Information Blog
Tuesday, April 22, 2008
Daily monitoring and last lens with the prescribing physician are advised.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment