Rev Posted October 16, 2004 http://story.news.yahoo.com/news?tmpl=stor...ssants_children FDA Orders Strong Antidepressant Warnings Health - AP By DIEDTRA HENDERSON, AP Science Writer WASHINGTON - All antidepressants must carry a "black box" warning, the government's strongest safety alert, linking the drugs to increased suicidal thoughts and behavior among children and teens taking them, the Food and Drug Administration (news - web sites) said Friday. Yahoo! Health Have questions about your health? Find answers here. Because the warnings are primarily seen by doctors, the agency also is creating a medication guide for patients to advise them of the risk. Dr. Lester Crawford, acting FDA (news - web sites) commissioner, said the agency sought to balance the increased risk of suicidal thoughts and behavior against the known benefit of treating depression in children. "We continue to believe, however, that these drugs provide significant benefits for pediatric patients when used appropriately," he said at a news conference. He said the new labels warn of the "risk of suicidality and encourages prescribers to balance this risk with clinical need." Prozac is the only antidepressant approved for use in children. On average, 2 percent to 3 percent of children taking antidepressants have increased suicidal thoughts, independent experts, working with Columbia University, found. The FDA announcement follows to the letter guidance from federal advisers. After searing and emotional public hearings one month ago, the advisers urged the agency to add its most strident warnings to the drugs. The FDA said in a statement that it recognizes that depression in pediatric patients "can have significant consequences in pediatric patients if not appropriately treated. The new warning language recognizes this need but advises close monitoring of patients as a way of managing the risk of suicidality." An information guide will be distributed with each antidepressant prescription. Parents will be advised to look for warning signs in children that include worsening depression, agitation, irritability, and unusual changes in behavior. Those worrisome signs could come within the first months of starting an antidepressant or when the drug's doses changes — higher or lower. To make sure the medication guide is available with each prescription or refill, Crawford said the FDA would work with manufacturers to develop "unit of sale" packaging for all antidepressants. In "unit of sale" packaging, a medication is distributed in its original container and pre-labeled by the manufacturer. It contains sufficient medication for one normal course of therapy. In 24 trials involving more than 4,400 patients taking antidepressants, researchers found a greater risk of increased suicidal thoughts and behavior during the first few months of treatment. Celexa, Prozac and Zoloft posed lower risks for children, researchers found, while Luvox, Effexor and Paxil had higher risks of increased suicidal thoughts and behavior. Prozac is the only antidepressant approved by the FDA for use for treating depression in pediatric patients. Anafranil, Prozac, Luvox and Zoloft have been used for treating obsessive compulsive disorder in pediatric patients. The new warnings, however, will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, , Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax,Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban. The agency's action comes at a time when it faces withering criticism for not acting sooner on antidepressants, and for the shortage of flu vaccine and the high-profile withdrawal of Vioxx for safety concerns. Congressional investigations have focused on allegations the agency silenced its own employees who tried to raise safety concerns on the antidepressants and Vioxx. Share this post Link to post Share on other sites
rkundalini Posted October 20, 2004 So sad that society is so fucked up that not only are kids suffering from clinical depression, but adults are drugging them to try to "fix" it. Far worse than Huxley imagined in Brave New World IMO. I suppose this is a step in the right direction but it's a tiny step backwards on a freight train going a million miles an hour... Share this post Link to post Share on other sites
Thelema Posted October 21, 2004 the standard line on describing the advent of these effects is a little worrying too. It goes back to an old psychological study done on people with depression, showing that at the depths of depression they were sufficiently unmotivated to realise suicidal thoughts into action. It was found during a post-hoc study that suicide rates actually increased in those whose depression scores had actually lifted; their uprising gave them enough motivation to carry out the action. So most specialists will give this as the reason as to why within the first month or so of taking SSRI your suicide likelihood is to increase....BUT after taking paxil/aropax for 8 months, a couple of years ago, one night I suddenly had a multitude of suicidal "voices" in my head. I could not control them, they were frantic and nasty. I have never experienced any drug to have effects like this, except for bad pot and am firmly convinced that these "suicidal ideations" are not the result of a depressed mind "rising" but are rather nasty side effects directly attributable to the [largely unknown] actions of these chemicals on the serotonin system of the brain. Share this post Link to post Share on other sites
