FDA Changes Wording on Antidepressant Warning

The Food and Drug Administration has backed off its warning that antidepressants such as Zoloft", default", Paxil and Prozac can cause suicidal actions among children and teens taking those prescription drugs.

Change comes to light during murder trial of teen blaming Zoloft
By Jim Polk
CNN

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.