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Depression Drugs to Carry a Warning
FDA Orders Notice Of Risks for Youths
By Shankar Vedantam
Washington Post Staff Writer
Saturday, October 16, 2004; Page A01
The federal government ordered yesterday that all antidepressant drugs carry a prominent "black box" warning to alert doctors that the medications increase the risk of suicidal thoughts and behavior among children and adolescents.
Clinical trials showed that children taking antidepressants have a 4 percent risk of suicidal thoughts and behavior, compared with a 2 percent risk among children getting placebos, said regulators at the Food and Drug Administration.
"The use of these products causes a statistically significant increase in suicidal thoughts and behavior among children," said Lester M. Crawford, acting director of the FDA. Crawford urged physicians to evaluate patients carefully before deciding whether the benefits of the drugs in treating depression and other disorders are worth the risks.
"In other words," added Sandra Kweder, acting director for the Office of New Drugs at the agency's Center for Drug Evaluation and Research, "these drugs should not be used casually."
The decision represents a major shift in the agency's long-standing position on the drugs and could significantly alter how they are marketed, prescribed and used.
Controversy has dogged antidepressants for more than a decade, but most psychiatrists have attributed patients' suicidal thoughts and behavior to illness, not medication.
Congressional investigators are looking into whether the FDA erred in not issuing warnings sooner. Yesterday's announcement came more than a year after investigators first learned of concerns over the antidepressant Paxil, 10 months after British authorities warned physicians not to use the drugs for children and eight months after an FDA scientist recommended warning the public about the drugs.
Critics have pointed out that the FDA has long had access to the studies on which today's warnings were based, which compared the risks of children taking drugs to children taking sugar pills. But the agency argued that the trials, conducted largely by pharmaceutical companies in recent years, did not clearly distinguish suicidal thoughts and behavior from other side effects. Officials defended their cautious approach as scientifically appropriate and argued that reevaluations of the data were necessary to lend certainty to their conclusions.
Psychiatrists have vigorously defended use of the drugs because untreated depression can be deadly. FDA officials had said they feared that warnings such as the one announced yesterday could scare families away from the drugs and deprive sick children of valuable treatment.
The American Psychiatric Association said it had "deep concern" over the black-box warning and its potential "chilling effect" on treatment. The association urged the FDA to track the consequences of the warning on prescribing patterns and "also track any increase in actions by patients to harm themselves as a result of reduced access to medically necessary treatment with antidepressants."
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janeeng said:Nato - saw a report on this not too long ago and read this earlier myself. I do know people on some of these and wondered. My Son also was diagnosed with ADHD and one Doctor mentioned Zoloft. He was put on Adderall, which I see isn't on the list. He isn't taking it now, even though he should be, and probably will be again soon, but I wonder reading some of this, if that will be next to be on the list. Any of those that do have kids on any of these, think about it, Adderall and Strattera are what most Doctors are giving out and swearing by for both kids and adults. Strattera is for both anxiety and depression, but has been found to do wonders for kids with ADHD.
NATO AIR said:that's interesting. i just pray no more of these kids commits suicide, for a parent that has to be the worst possible nightmare.
janeeng said:I hear that - when this ad ran once before about Paxil, a Mother of a child who took her own life also pleaded with everyone to think twice about putting their children on this stuff. Who would have thought that medicine to help depression could only intenisfy it and make you want to die? it's really sad.
dilloduck said:I'm still a little leary of the science behind this. If the person is already depressed and suicidal whats to say that the medication simply didn't work at all. Too many parents rely only on the meds and don't follow the recommendation to get counseling TOO.
dilloduck said:I'm still a little leary of the science behind this. If the person is already depressed and suicidal whats to say that the medication simply didn't work at all. Too many parents rely only on the meds and don't follow the recommendation to get counseling TOO.
janeeng said:Dillo - you hit the nail on the head with you last sentence, FOLLOWING UP WITH COUNSELING!!! Yes, too many doctors today throw medicine at a kid - but, in my Son's case, and I know my Family would back it up...Unfortanately, the child has been through a lot growing up, and never seemed to get the attention and love he needed from his Father, always trying to fight for his love, he became angry, and couldn't concentrate in school, and was hyper. The Doctor didn't want to just put him on medicine till he was fully studied. He did finally put him on Adderall. At the time he started it, within hours, he was a new kid, helping me clean, nice to his Sister, but most of all, took his time with schooling. His writing was much neater and paid more attention in school. The Doctor said, most importantly, he needed counseling to bring out whatever else was going on in him. I tried that, and he wouldn't do it. It was tough. I also found after a while that my Son was hiding his medicine. Well, long story short, his Father no longer resides with us, making that easier on him, but still struggling to fit in his life, a Father who's needs come first before his Children. My Son now needs to go back to the doctors and begin the medication again, but now, he will also need the counseling more so now then before. It's tough, but I also realize now, that if I don't help my Son soon, not doing this will only become a sadness in itself in the end. At 9, he has talked about how he would rather be dead, and to hear a child at 9 say this, you know HELP is needed.
I don't believe medicine should be a permanent solution, but rather the counseling and the nurturing of my Son, giving him love, and the attention he seeks is what will turn him around. A long tough road, but in the end, will truly be worth getting back the Son I once had.
krisy said:I saw a story on this too and it was so scary because the girl that committed suicide showed no signs at all. What a nightmare. I have a 16 year old younger brother that was on Ritlin(sp?) for a long time. He has been off of it for a year or 2 now and is just fine. The doctor didn't want my mom to take him off it and she did anyway. She has wondered if they were right in giving it to him. He was like a zombie on the stuff and then when it wore off,was starving. I beleive that these drugs are overprescribed. These are our kids.
janneng,I wish you good luck.I know sometimes the medications are necessary. I mainly think the Ritlin type medicines are given out to much. It's a shame a little girl had to loose her life for us to find out what these anti depressants are doing.
Mr. P said:I used to have a link to a report that showed Drug companies have know about
these effects for sometime, but withheld the information, especially from Docs.
IMO..we medicate way too many kids these days. Especially the ones with supposed ADD.
janeeng said:Thanks guys, I sure hope all turns out well. I tried to deny it all again, and now know I can't.
