FDA e adulti

ricevuto da Francesco Troccoli



First World, da:

CNN Health; Los Angeles Times; The New York Times

FDA to examine clinical trial data on adult antidepressant use

William Kanapaux



09/29/2004

The FDA is preparing to analyse the clinical trial data involving the use of antidepressants in adults to determine whether a link exists between the drugs and an increase in suicidal thoughts and behaviours for this patient population, as reported in news sources. The same analysis technique used by Columbia University researchers on data from paediatric trials of antidepressant usage will be utilised for the much larger pool of adult data, which covers 234 clinical trials involving about 40,000 depressed adults. Acting FDA Deputy Commissioner Dr. Janet Woodcock described the analysis as "a huge undertaking" without estimating how much it would cost or how long it would take. An examination of the data from paediatric trials, which is only 10 percent the size of the adult data, revealed a link between antidepressant use and increased suicidal tendencies in two to three of every 100 children, as reported in CNN. That finding prompted a call by federal advisory panels for the FDA to place a black-box warning on all antidepressants. Dr. Wayne K. Goodman, who served as chair of a joint meeting of the advisory panels, said that the new analysis would help reveal possible trends in young adults. "We drew the line at 18," he is quoted as saying in news sources. "But some of the same mechanisms that could be responsible for suicidality in a small fraction of patients would be operative in people who are 19, 20, 21. Who is to say?"