US antidepressant prescribing falls in under-18s
pharmafile | September 23, 2004 | News story | |
Growing concerns over the safety of giving SSRI antidepressants to children and adolescents has resulted in a sharp fall in US prescriptions for under-18s, new data shows.
Medco, one of America's biggest prescription drug brokers called pharmacy benefit managers says there was a 24% drop in the number of under-18s on antidepressants in the first half of the year, corresponding closely with warnings from regulators the FDA.
"The data appears to support that information and education is a powerful tool to improve our health care delivery system," said Dr Robert Epstein, Medco chief medical officer.
"Studies show that greater caution is needed when treating paediatric and teen depression with medication, and it not clear that physicians are heeding these warnings."
In March this year, the FDA told companies in the SSRI/SNRI antidepressant market that they must carry new stronger warnings on their labels detailing risks and potential suicidal tendencies in children and teenagers.
Further investigation of data from the companies by an FDA committee produced recommendations of further warnings, including a black box warning. The FDA says it 'generally supports' the recommendations, which includes making all the drugs carry the same warnings, citing a lack of evidence to justify exceptions.
Medco data also show that spending on antidepressants for children grew 25% between 2000 and 2003, while use of the drugs rose 27%. The company says this is part of a wider growth in prescribing for all behavioural conditions, which rose 77% over the same period. One of the largest increases was in treatments for attention deficit/hyperactivity disorder (ADHD) where spending increased by 183% for children overall, and by 369% in children under five.
None of the antidepressant drugs are licensed for use in children except Lilly's Prozac (fluoxetine) which gained a paediatric licence from the FDA on the basis of dedicated trials which demonstrated its safety and efficacy.
Companies involved including GlaxoSmithKline, maker of Paxil/Seroxat, and Wyeth, which markets Efexor XL, say they have never promoted their drugs for use in children, but doctors increasingly prescribe the drugs off-label because of the growth of depression and similar disorders in children.
The World Health Organisation says an estimated 10-20% of children have one or more mental or behavioural problems, with around two million children and adolescents suffering from depression in the US.
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Thursday , June 24, 2004
