Antidepressants Raise Suicide Risk in
Some Children and Teens, FDA Says
by Kevin Caruso
September 14, 2004
Top Food and Drug Administration officials acknowledged for the first time that antidepressants appear to raise the risk of suicide in some children and teenagers.
Testifying before two FDA advisory committees, the officials indicated that a recent Columbia University study that was contracted by the FDA showed that the drugs significantly increased the incidence of suicidal behavior in children and teenagers.
"I think that we now all believe that there is an increase in suicidal thinking and action [among children and teenagers] that is consistent across all the drugs, said Dr. Robert Temple, director of the FDA's office of medical policy.
This acknowledgement has come a year after the agency withheld conclusions of Dr. Andrew Mosholder, the FDA's drug safety analyst, who found a link between antidepressants and suicide in children and teenagers. Internal FDA memos indicated that many believed the data to be unreliable, and thus the FDA requested additional research at Columbia University.
The testimony was given to an advisory committee consisting of 31 independent experts.
Angry family members of suicide victims castigated the agency for waiting so long to divulge the information.
Mathy Milling Downing of Laytonsville, Md., whose 12-year-old daughter hanged herself in January, said: "Candace's death was entirely avoidable had we been given the appropriate warnings.The blood of these children is on your hands."
Thomas Woodward, a businessman from North Wales, Pa., whose 17-year-old daughter, Julie, hanged herself a week after beginning therapy with Zoloft, said: "The senior leadership at FDA drag their feet and make Orwellian statements such as 'Just because these drugs have been proven to be effective does not necessarily mean they're ineffective' . [The FDA officials] know the truth and therefore have blood on their hands."
(A memorial page to Julie Woodward is on Suicide.org. Please click the following link to visit Julie's Memorial:
Julie Woodward Memorial)
Raul Languerre of Newburgh, N.Y., said his son may spend many years in prison because of an act of violence he committed when he was on antidepressants. (Languerre did not want to give the name of his son or details about the incident because his son has not yet gone to trial.)
"Before he took these drugs he was a gentle, lovable kid who never hurt himself or any other person," said Languerre. "The FDA needs to step up and protect the consumer and crack down on these drug companies before more lives are lost."
Alice Erber said Paxil caused her 21-year-old son, Jake Steinberg, to jump to his death from the 24th floor of a Manhattan office building.
But the drug companies and some doctors maintain that the medicines need to remain available for the treatment of children and teenagers.
Dr. David Fassler, who testified on behalf of the American Psychiatric Association, said that each antidepressant was effective for some young patients.
"Most clinicians believe, and I would concur, that for children and adolescents who suffer from depression, the potential benefit from these medicines far outweighs the risk," said Fassler.
Drug company representative were not in agreement as to whether the FDA should consider the antidepressants individually or collectively with respect to regulatory action.
Dr. Steven Romano of Pfizer said that suicidal behavior should be considered much more seriously than suicidal thought with respect to regulatory action. (Pfizer produces the antidepressant Zoloft, which was linked to more instances of serious suicidal thought than suicidal behavior in the Columbia University study.) "The risk or benefit of antidepressant use should be assessed on an individual product basis," Romano said.
But Dr. Joseph Camardo of Wyeth Pharmaceuticals said that the data did not justify treating one antidepressant different from the other. "The information should be consistent for all of the antidepressants," he said.
Effexor, a Wyeth Pharmaceuticals drug, has consistently shown the highest ratio of serious suicidal thought and behavior (of all the drugs studied) compared with patents taking placebos.
As you can see, the self-serving statements spewed by the representatives of the drug companies
focus on protecting their drugs and profits instead of protecting our children and teens!
The advisory committee will advise the FDA on how to respond the problem with antidepressants and young people.
"I think the work is cut out for us," said Wayne Goodman, chairman of the advisory committee.
It should be noted that antidepressants have helped many children and teens overcome their depresssion and suicidal thoughts,
so the option of taking them should at least be explored; but proceed with great caution and consider
all other options before making a decision.
And conduct as much research as possible. You want to be extremely knowledgable about antidepressants.
Know all of the risks.
And if a phsychiatrist recommends antidepressants, you may want to get a second or even a third opinion from other psychiatrists.
And please monitor your child as closely as possible if you do allow him or her to take antidepressants and immediately report any significant change in behavior to the psychiatrist.
The decision as to whether or not your child takes antidepressants will be up to you and your child -- do not let anyone force something upon you that you do not want to do.
And make sure that all of your questions are answered before you allow your child to take antidepressants.
And if you do not like the psychiatrist who is treating your child, consider finding another one.
Again, conduct as much research as possible, monitor your child very closely, and do not hesitate to get another opinion or change psychiatrists
If you or someone you know is suicidal, please go to the Home Page of this website for immediate help.
I love you.