ricevuti da Francesco Troccoli
17-09-04
The FDA said that it "generally supports" its advisory committees' conclusion that certain antidepressants may increase the risk of suicidal behaviour in children and adolescents, CBS MarketWatch and CNN report. Other recommendations from the advisory panels "included tough warnings for all antidepressants sold as well as a pamphlet in patient-friendly language to be handed out with every prescription," the agency said in a statement as reported in CNN. FDA's decision would apply to all antidepressant drugs including Eli Lilly's Prozac, CBS MarketWatch reports. Prozac is currently the only antidepressant approved by the agency for use in children. The antidepresssants studied in the panels' review included Lilly's Prozac, Pfizer's Zoloft, GlaxoSmithKline's Paxil and Wellbutrin, Forest Laboratories' Celexa, Wyeth's Effexor, Solvay's Luvox and Akzo Nobel's Remeron. The panels said its safety concerns applied to all the drugs reviewed. They also recommended that the stronger warnings should appear on older antidepressant drugs such as tricyclics. Not everyone is certain that the warnings, highlighting a small increase in risk associated with the drugs, are a positive step because they might discourage treatment for depression in teens and children, which in itself carries a risk of suicide. "We believe the biggest threat to a depressed child's well-being is to receive no care at all," the American Psychiatric Association said in a statement, as reported in CNN. Nonetheless, the agency's move is not as strong as that taken in other countries. Earlier in the year, the UK banned the use of most antidepressants in children and adolescents, CBS MarketWatch reports.
21-09-04
A British expert on psychiatric drugs who warned last year about the risk of suicidal behaviour among children who take antidepressants now says that UK regulators are ignoring evidence that SSRIs may make people aggressive and even homicidal, news sources report. Dr. David Healy, director of Cardiff University's North Wales department of psychological medicine, said Monday that data from clinical trials indicate that even healthy adult volunteers have had hostile reactions. "I think there is very clear evidence for all of the SSRI group of drugs that in addition to making people suicidal, they can make people homicidal or seriously aggressive," Healy is quoted as saying in The Guardian. "I'm not saying these drugs should be banned, but people should be warned about these risks when they are put on these pills." For example, Healy highlighted the results of a GlaxoSmithKline Seroxat trial, which is sold in the US as Paxil, from the late 1980s and early 1990s that showed that three of 271 healthy volunteers became hostile, compared with none on placebo, the news sources report. Healy contends that the 1.1 percent rate translates into a vast number of people considering that 50 million people worldwide have taken the drug over the last 15 years. A Glaxo spokesman said there is no compelling evidence showing that the drug causes hostility in adults. "When you put the results from all the clinical trials together, there is no difference between the rates of hostility for adult patients taking Seroxat and the patients taking dummy pills," he is quoted as saying by the BBC. "This data has been shared with regulators."
