Miscellaneous Drugs for Children
Prozac Approved for Depression in
Children
The Food and Drug Administration has approved
new uses for the antidepressant Prozac (fluoxetine) to treat
children and adolescents seven to 17 years of age for depression
(major depressive disorder) and obsessive compulsive disorder
(OCD). This is the first approval of one of the newer types
of antidepressants (selective serotonin reuptake inhibitors
or SSRIs) for treating depression in this population.
FDA Talk Papers FDA
Approves Prozac for Pediatric Use to Treat Depression and OCD January
3, 2003
U.S. Approves use of Prozac for Children
A recent NY Times
article reports: WASHINGTON, Jan. 3 (Bloomberg News) - Prozac, the antidepressant
made by Eli Lilly, was approved for treating children and adolescents
with depression, federal regulators said today.
The Food and Drug Administration cleared Prozac for use in treating patients
7 to 17 years of age, the agency said after reviewing Lilly's research on the
drug's safety. Lilly does not plan to promote the depression pill for children,
the company said.
For years, doctors have prescribed Prozac and similar drugs for children even
though these medications were approved only for adults. Federal officials wanted
to review safety issues for the drug, once the world's top-selling depression
treatment with annual sales of more than $2 billion.
Reported adverse drug events in infants
and children under 2 years of age
Adverse reactions to drug therapy are a
significant cause of death and injury in infants and children
under 2 years of age. Drugs administered to the mother in
the perinatal period constituted a major route of exposure
to adverse drug advents. These results underscore the need
for additional drug testing in the youngest pediatric patients
and for carefully weighing the risks versus benefits of medication.
Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ Reported
adverse drug events in infants and children under 2 years of age Pediatrics
2002 (Nov); 110 (5): e53
More on Psyciatric Drugs
This article reveals the potential hazards
of the common overused psyiatric drugs in our modern society
It gets into the legal struggles the drug companies go through
to maintain their percieved flawless reputation.
Richard DeGrandpre The
Lilly Suicides August 22, 2002
Off label drug prescribing--again
"Studies in various hospital
settings showed that many drugs taken by children either are not licensed
or are used outside the terms of the product licence.1-3
Information on the extent of paediatric labelling of drugs
taken by children in the community is, however, limited and
based on small study populations. 4 5 We studied drugs taken
by children in the community, based on the pharmacy records
of prescriptions from both general practitioners and outpatient
departments. We aimed to determine the number of prescriptions
for unlicensed drugs for children in the community and to
investigate paediatric labelling of all drugs with a product
licence to determine the extent of off label use."
FDA urges stronger warnings on antidepressants
: The agency had issued a warning last year on antidepressant
use in children, "but Monday's action -- especially the addition
of the warning to drug labels -- goes significantly further.
Click
for Source
http://my.webmd.com/content/article/84/98068.htm