Black Boxes On Antidepressants Worked: Study
4 CommentsBy Ed Silverman // January 7th, 2008 // 4:23 pm
Those FDA warnings about the risk of suicidal thoughts and behaviors in children and adolescents taking those meds appear to have had “modest and targeted effects on the intended populations,” according to a study in Archives of General Psychiatry (subscription may be required).
Relying on data from the Medco pharmacy benefits manager, the researchers analyzed trends in antidepressant use for three age groups - kids between 6 and 17 years old; adults aged 18 to 64, and those 65 and older. And they examined the usage over three time periods - May 1, 2002 to June 19, 2003, before any warnings were issued; June 20, 2003 to Oct. 15, 2004, when a warning was issued on Glaxo’s Paxil, and from Oct. 16, 2004 to Dec. 31, 2005, during which time Black Box warnings were issued and showed up on the other antidepressants.
“After the FDA first recommended not treating youth with (Paxil), there was a significant absolute decline in (Paxil) use by youth, but not significant declines in use of other antidepressants by young people,†the authors write. “Similar, though less pronounced, declines occurred in (Paxil) treatment of older patients. Following the black box warning, there was a statistically nonsignificant decline in antidepressant treatment of youth, including a significant deceleration in the rate of treatment with SSRIs other than paroxetine.â€
“Concern has been expressed that the FDA advisories may have resulted in excessive declines in antidepressant prescribing, thereby putting depressed youth at increased risk. Our report indicates that the absolute rate of overall antidepressant treatment of youth did not significantly decrease during the period of FDA regulatory activity,” they wrote.
“From 1985 to 1999, there was a four-fold national increase in per capita antidepressant prescriptions,†they write. “The FDA warnings appear to have slowed this longer-term growth of antidepressant treatment of children and adults. Despite fears that these advisories might result in a precipitous decline in antidepressant prescribing, it is reassuring that the pattern of changes in treatment, which were modest in size and greatest for treatment of youth, were broadly consistent with the FDA warnings and the scientific literature.â€
Translation: Despite concerns by some physicians that the FDA warnings were draconian and unnecessarily discouraged appropriate usage, the data indicates that wasn’t the case.
Lisa Van S
Interesting,.. For once, I am at a loss for words.
Laurie
“it is reassuring that the pattern of changes in treatment, which were modest in size and greatest for treatment of youth, were broadly consistent with the FDA warnings and the scientific literature.”
Am I reading this right???? They are content with switching to other ssri’s that carry the exact same warnings? Unbelievable!!!
Lisa Van S
Ed,
Nothing personal here, but, I found that med page NJ explained this study a little clearer. Dr. Olfson should be commended for a job well done. And if anyone in Pharmalot land knows Dr. Olfsen, please tell him I said Thank You.
Laurie
” “The concern that the warnings would have a chilling effect on the treatment of depression in young people was not born out by the data,†said the study’s lead author, Dr. Mark Olfson, a professor of clinical psychiatry at Columbia. ”
A clearer end point of the study.