13 recommendation by the FDA's Psychopharmacologic
Drugs Advisory Committee would extend the warning of increased risk of suicidality associated with selective serotonin reuptake inhibitors and other antidepressants to include patients up to age 25, rather than just children and adolescents.
She also stressed the importance of knowing the diagnostic criteria for Tourette syndrome, as well as the best psychopharmacologic
and behavioral treatment interventions.
Data gathered from ongoing research will be analyzed and used to assist in determining the efficacy and dosing of psychopharmacologic
At a meeting last month, the FDA's Psychopharmacologic
Drugs Advisory Committee voted 9-8, with 1 abstention, that inhaled loxapine should be approved for use as a single dose in 24 hours with an FDA-proposed risk management plan that addresses the increased risk of treatment-associated bronchospasm, particularly in patients with asthma.
At a meeting of the FDA's Psychopharmacologic
Drugs Advisory Committee, the panel members were mainly concerned about modafinil's potential to cause Stevens-Johnson syndrome (SJS).
At a joint meeting of the FDA's psychopharmacologic
drugs advisory committee and the pediatric subcommittee of the anti-infective drugs advisory committee, panel members supported that idea to heighten the awareness of symptoms that can occur with those drugs, including signs of activation syndrome and akathisia.
WASHINGTON--(BUSINESS WIRE)--July 16, 1996--The Psychopharmacologic
Drugs Advisory Committee to the U.
Drugs Advisory Committee voted 11-2 with no abstentions in middle September that data from the trial were sufficient to demonstrate efficacy, 10-1 with 2 abstentions that the data could be applied to the U.
During a meeting of the FDKs Psychopharmacologic
Drugs Advisory Panel in December, the agency heard from several advisers and others that a "substantial fraction" of children have difficulty taking pills, Dr.
At a meeting, the FDA's Psychopharmacologic
Drugs Advisory Committee voted 7-4 that the available data supported the "reasonable safety" of the 20-mg formulation of a transdermal patch containing the irreversible MAO inhibitor selegiline without a recommendation to restrict aged cheeses and other tyramine-rich foods in the diet.
But because these disorders have multiple component problems, the use of combined psychopharmacologic
intervention is common and appears to be the most efficacious for the patient.
Child psychologists--in addition to providing diagnostic, testing and treatment skills--may be good conduits to the psychiatrists most familiar with unique psychopharmacologic
issues in children.