FDA backs away from antidepressant warning

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SSRI-Research@

Wed, 9 Feb 2005 19:08:35 -0500

[sSRI-Research] SSRIs: FDA CHANGES BLACK BOX WARNING

 

 

 

Paragraph 5 reads: " Limiting the warning language to a risk seen in

studies, rather than saying the drugs actually could cause suicidal

behavior in younger patients, is a significant retreat for the FDA and

came after several months of lobbying by the pharmaceutical industry. "

 

http://www.cnn.com/2005/HEALTH/conditions/02/09/fda.antidepressant/

 

 

 

 

FDA backs away from antidepressant warning

 

 

 

Change comes to light during murder trial of teen blaming Zoloft

By Jim Polk

CNN

Wednesday, February 9, 2005 Posted: 4:14 PM EST (2114 GMT)

 

CHARLESTON, South Carolina (CNN) -- The Food and Drug Administration

has backed off its warning that antidepressants such as Zoloft, Paxil

and Prozac can cause suicidal actions among children and teens taking

those prescription drugs.

 

Instead, the FDA, in a revised warning posted last week on its Web

site, changed the wording to say only that the drugs " increased the

risk of suicidal thinking and behavior in short-term studies of

adolescents and children " with depression and other psychiatric disorders.

 

News of the FDA's warning change surfaced Wednesday in testimony here

in the murder trial of 15-year-old Christopher Pittman. The defense

contends Zoloft drove him to kill his grandparents when he was 12.

 

Dr. Steve Romano, a psychiatrist and a vice president of Pfizer, which

makes Zoloft, mentioned the FDA change at Pittman's trial while being

questioned about the company's own clinical trials for Zoloft.

 

Limiting the warning language to a risk seen in studies, rather than

saying the drugs actually could cause suicidal behavior in younger

patients, is a significant retreat for the FDA and came after several

months of lobbying by the pharmaceutical industry.

 

The agency has never approved Zoloft, Paxil or most similar drugs for

use by younger patients with depression. Even so, many doctors

prescribe them for children and teens. Prozac is the only such

antidepressant approved to treat depression in children.

 

The version of the warning that the agency posted on its Web site in

October included this sentence: " A causal role for antidepressants in

inducing suicidality has been established in pediatric patients. "

 

The latest version omits that sentence.

 

The sentence was not part of the boldface black-box warning placed at

the start of the insert that accompanies any prescription, but instead

appeared in the first paragraph of a separate section on " Suicide

Risk " which appeared just below that black box.

 

The replacement sentence, however, appears as the first sentence

inside the black box. That first sentence was broader in the original

version, saying: " Antidepressants increase the risk of suicidal

thinking and behavior in children. " The new version qualifies that by

inserting the phrase " in short-term studies. "

 

Romano acknowledged that the wording change was preceded by an

extended " dialogue " between his drug company and others, and the FDA.

 

Romano was called by the defense in the Pittman case to testify about

suicide-related warnings issued both in Canada and the United States.

 

The FDA never has suggested there is any link between these drugs and

violence against others -- the issue in the Pittman murder trial.

 

The trial is in its eighth day and appears likely to spill over into a

third week, rather than go to the jury by this weekend, as originally

predicted.

 

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