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.

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