ricevuto da Francesco Troccoli
"First World" riprende da: Bloomberg; CBS MarketWatch; CNN Health; Forbes; Morningstar; The New York Times
FDA orders black box warning for antidepressants
William Kanapaux 15.10.04
The FDA on Friday announced that all antidepressants must carry a black box warning that says the drugs are linked to an increased risk of suicidality among children and adolescents, as reported in news sources. The agency is also creating a medication guide that pharmacists will be required to distribute to patients with each prescription. The FDA said it will work with drugmakers to develop "unit of use" packaging so that the medication containers are pre-labelled by the manufacturer. The FDA also said that Pfizer, Wyeth and other antidepressant manufacturers would have to change television ads and other promotional materials, Bloomberg reports. The changes take effect immediately and apply to all drugs including Eli Lilly's Prozac, which is the only one approved for use in children. The new labels must include data from paediatric studies that show Prozac is the safest such drug for young people so far, Forbes reports. Acting FDA Commissioner Dr. Lester Crawford said that the agency sought to balance the risks of using the drugs in younger patients with the benefits. "We continue to believe ... that these drugs provide significant benefits for paediatric patients when used appropriately," he is quoted as saying. The new labels encourage patients to balance the risk of suicidality with clinical need, he said as reported in USA Today. But the American Psychiatric Association said in a statement that it was deeply concerned the black box warning "may have a chilling effect on appropriate prescribing for patients. This would put seriously ill patients at grave risk," CBS MarketWatch quotes the organisation as saying.
