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Posted on 02/03/2004 10:52:46 AM PST by Nov3
Kids Face Risks Taking Antidepressants
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WASHINGTON (AP) - Parents need warnings that popular adult antidepressants may sometimes spur suicide when taken by children and teenagers, government advisers said Monday after hearing emotional testimony from families who lost loved ones.
It isn't clear yet that the drugs lead to suicide, but until that is settled, parents and doctors need to know they may cause agitation, anxiety and hostility in a subset of young patients who may be unusually prone to rare side effects, advisers to the Food and Drug Administration concluded.
"We want to put a speed bump in the road," said panel chair Dr. Matthew Rudorfer of the National Institute of Mental Health. "The warnings as they exist in the current labeling are not adequate or are not being taken seriously."
British health authorities sounded the alarm last year, saying long-suppressed research suggests certain antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Because only one drug, Prozac, has been proven to alleviate pediatric depression, Britain declared others - drugs called SSRIs and their close relatives - unsuitable for depressed youth.
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Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. But 109 patients experienced one or more possibly suicide-related behaviors or attempts, FDA medical reviewer Dr. Thomas Laughren revealed Monday.
The problem, he said, is that studies varied dramatically in what was considered suicidal behavior. Among 19 patients classified as cutting themselves, for instance, almost all were superficial, with little bleeding. So FDA has hired Columbia University to help determine exactly how much true suicidal behavior occurred, before it proposes next steps at a second public hearing in late summer.
Meanwhile, FDA has warned doctors to use great caution in prescribing any antidepressant other than Prozac to people under 18.
That's not enough, said anguished parents who want warnings of the possible suicide risk on the drugs' labels.
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"Please, save our children," said Todd Shivak of Michigan, whose 11-year-old son Michael slashed his wrists in class, but survived, while taking Paxil.
Parents described youths becoming extremely agitated or anxious shortly after starting the pills - symptoms known medically as akathisia - and seemingly sudden impulses that turned deadly.
FDA's scientific advisers warned that the youths most likely to commit suicide weren't allowed into the SSRI studies, so existing data likely won't settle the issue.
But the panel urged FDA to heed parents' reports about akathisia - and to run some sort of education campaign about those symptoms, so young patients can be better monitored.
"Perhaps just looking at suicide attempts may not be all the answer," said Dr. Joan Chesney, a University of Tennessee pediatrician.
"I doubt that pediatricians or family practitioners are aware of the level of concern about this potential problem," said Dr. Norman Fost, a University of Wisconsin pediatrician and bioethicist. Until FDA settles the issue, "you should be very alert to the risks of these drugs, be very alert to this ... syndrome."
Some families also blamed murder and school violence on the drugs.
"These drugs are hell, look what they've done to my son," say Jay Baadsgaard after his son Corey described taking Effexor and then waking up in jail, claiming no memory of holding his Mattawa, Wash., class hostage at gunpoint four years ago.
But a few parents, despite boos from the crowd, credited the drugs with saving their children.
"I ask that you appreciate the enormous benefit these medicines have had," said Sherri Walton of Arizona, whose 14-year-old daughter Jordan has used SSRIs in a years-long battle with obsessive-compulsive disorder and depression. "Her medicines were sometimes the only things she could depend on to help her."
"I shudder to think of their plight if these medicines were not available," added Suzanne Vogel-Scibilia of the patient group National Alliance for the Mentally Ill, who say the drugs dramatically improved depression in two of her teen sons, including one who had attempted suicide.
FDA officials fear warnings before the issue is settled could dissuade patients from potentially helpful treatment. "To err in either direction has significant consequences," said Laughren.
Depression occurs in up to 10 percent of youth, and 1,883 10- to 19-year-olds killed themselves in 2001. Some 1.8 million teenagers attempted suicide that year, a quarter of them requiring medical attention, said Dr. David Schaffer of Columbia University.
In 2002, almost 11 million prescriptions were dispensed to patients under 18 for SSRIs and other newer antidepressants, to treat depression and a host of other conditions, FDA said.
These drugs are godsends for a minute portion of the population. They are very powerful and have dangerous side effects. They should never have been marketed and prescribed like they are. Serafem is one of the worst! All to market to the public as a whole.
From an article in the Washington Post By Shankar Vedantam Washington Post Staff Writer Tuesday, May 7, 2002
A new analysis has found that in the majority of trials conducted by drug companies in recent decades, sugar pills have done as well as -- or better than -- antidepressants. Companies have had to conduct numerous trials to get two that show a positive result, which is the Food and Drug Administration's minimum for approval. What's more, the sugar pills, or placebos, cause profound changes in the same areas of the brain affected by the medicines, according to research published last week. One researcher has ruefully concluded that a higher percentage of depressed patients get better on placebos today than 20 years ago.
Against Depression, a Sugar Pill Is Hard to Beat
I think most people, if not all, would be better off having nothing to do with anti depressants. It's just a way to get you hooked on drugs so as to have a captive market for repeat sales.
I do however, think that meds are over-perscribed, either because parents find a drugged kid easier to deal with, or because schools threaten parents with the authorities if they do not med.
Little boys in particular get medded when they ought not to be, simply for being little boys.
Male behavior is no longer tolerated in this society and there are some people who think that drugs are the answer.
There were reports of increased suicides occuring after Prozac entered the market. Mental health workers realized this and now suicidal patients are watched very carefully after started on antidepressants in inpatient settings. The problem seems to be reoccurring in teens, I think because family doctors may be starting them on these meds in outpatient settings, and not educating the family on the powerful side effects sufficiently.
We'll see. Hope you're right. Note that the FDA committee put off a final decision until they can "re-analyze" the drug company clinical trial data to see if all the suicide attempts were accurately categorized.
BTW, Mark Miller -- who spoke at the FDA hearing yesterday and was quoted in this article -- has written a very compelling story about his son.
He Never Said Good-Bye (PDF document)
You have sucessfully followed the party line. You really need to do some more research on this. Unfortunately it is going to come down to a bunch of trial lawyers getting rich off of family tragedies.
Here is a quote from another article posted today.
"To die in this violent, unusual fashion without making a sound ... Paxil must have put her over the edge," said Sara Bostock, describing how her daughter Cecily stabbed herself in the chest with a kitchen knife shortly after graduating from Stanford University and two weeks after starting the drug.
Another parent agreed.
"You have an obligation today ... from preventing this tragic story from being repeated over and over again," said Mark Miller of Kansas City, Mo., whose son Matt hanged himself in his bedroom closet after taking his seventh Zoloft tablet.
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