|
 FDA
Launches a Multi-Pronged Strategy to Strengthen Safeguards for
Children Treated With Antidepressant Medications
U. S. Food and Drug Administration, October 15, 2004
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The Food and
Drug Administration (FDA) today issued a Public Health Advisory
announcing a multi-pronged strategy to warn the public about the
increased risk of suicidal thoughts and behavior ("suicidality")
in children and adolescents being treated with antidepressant
medications.
The agency is directing manufacturers to add a "black box"
warning to the health professional labeling of all
antidepressant medications to describe this risk and emphasize
the need for close monitoring of patients started on these
medications. FDA has also determined that a Patient Medication
Guide (MedGuide), which will be given to patients receiving the
drugs to advise them of the risk and precautions that can be
taken, is appropriate, and is in the process of developing one.
"Today's actions represent FDA's conclusions about the increased
risk of suicidal thoughts and the necessary actions for
physicians prescribing these antidepressant drugs and for the
children and adolescents taking them. Our conclusions are based
on the latest and best science. They reflect what we heard from
our advisory committee last month, as well as what many members
of the public have told us," said Dr. Lester M. Crawford, Acting
FDA Commissioner.
In letters issued today, FDA directed the manufacturers of all
antidepressant medications to add a "black box" warning that
describes the increased risk of suicidality in children and
adolescents given antidepressant medications and notes what uses
the drugs have been approved or not approved for in these
patients. FDA's letters to the manufacturers also discuss other
labeling changes designed to include additional information
about pediatric studies of these drugs. These labeling changes
are applicable to the entire category of antidepressant
medications because the currently available data are not
adequate to exclude any single medication from the increased
risk of suicidality.
Prozac is currently the only medication approved to treat
depression in children and adolescents. The analyses of the
placebo controlled trials in children and adolescents summarized
in the revised labeling are based on studies of five selective
serotonin reuptake inhibitors (SSRIs) (Celexa, Prozac, Luvox,
Paxil and Zoloft) and four "atypical" antidepressants (Wellbutrin,
Remeron, Serzone and Effexor XR). In these studies, there was no
reported case of a suicide.
A "black box" warning is the most serious warning placed in the
labeling of a prescription medication. Advertisements that serve
to remind health care professionals of a product's availability
(so-called "reminder ads") are not allowed for products with
"black box" warnings. Until now, only ten drug products approved
for children contained a black box warning about their use in
children. The new warning language does not prohibit the use of
antidepressants in children and adolescents. Rather, it warns of
the risk of suicidality and encourages prescribers to balance
this risk with clinical need.
FDA recognizes that depression and other psychiatric disorders
in pediatric patients can have significant consequences if not
appropriately treated. The new warning language recognizes this
need but advises close monitoring of patients as a way of
managing the risk of suicidality.
The second element of the agency's strategy is a Patient
Medication Guide (MedGuide), FDA-approved user-friendly
information for patients. MedGuides are intended to be
distributed by the pharmacist with each prescription or refill
of a medication. FDA will work with the manufacturers of
antidepressant medications to make the MedGuides available as
soon as possible.
In addition, FDA intends to work with manufacturers to implement
"Unit of Use" packaging for all antidepressants as a means of
ensuring that patients receive a MedGuide with every
prescription or refill. "Unit of use" packaging is a method of
preparing a medication in an original container, sealed and
pre-labeled by the manufacturer, and containing sufficient
medication for one normal course of therapy.
Today's actions are consistent with the recommendations made at
the September 2004 joint meeting of the FDA's
Psychopharmacologic Drugs Advisory Committee and Pediatric Drugs
Advisory Committee.
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