Sep. 4--Wyeth is alerting doctors about increased reports of hostility, suicidal thoughts, and self-harm in children who took its antidepressant, Effexor.

The letter comes after the U.S. Food and Drug Administration said in June that no one under age 18 suffering from major depression should be prescribed Paxil, another popular antidepressant drug made by GlaxoSmithKline. The agency said then it was reviewing reports of a possible increase in suicide attempts with Paxil. An FDA spokeswoman said Wednesday it is reviewing clinical data regarding antidepressant use by children.

In a letter dated Aug. 22, Madison (NJ)-based Wyeth told doctors it added the following prescribing information for Effexor and Effexor XR, a long-acting version:

"In pediatric clinical trials, there were increased reports of hostility, and especially, in Major Depressive Disorder, suicide-related adverse events such as suicidal ideation [thoughts] and self-harm."

In the letter, Wyeth said that in a depression study, 2 percent of children and adolescents treated with Effexor XR had suicidal thoughts compared with none taking a placebo, while 2 percent displayed hostility against less than 1 percent in the comparison group. In a study of generalized anxiety disorder, 1 percent of Effexor XR patients showed abnormal or changed behavior compared with none in the placebo group. The company did not say how many patients were in the studies. There were no suicides in the trials, the company said.

The company also says in the letter that the drug is not recommended for use in children. Doctors can prescribe drugs "off-label" in children even if they lack specific pediatric approval.

Thousands of physicians who prescribe Effexor -- Wyeth's top-selling drug -- received the letter, said company spokesman Doug Petkus.

"What prompted the letter is simply we thought the information was important," Petkus said.

Effexor acts differently than selective serotonin reuptake inhibitors, or SSRIs, the class of drugs that includes Paxil, Prozac, and Zoloft. It regulates levels of another brain chemical, norepinephrine, as well as serotonin.

Prozac is the only one of the newer drugs approved for treating depression in children.

The U.S. warning for Paxil followed one issued by British authorities. Should the decision be made, taking children off Effexor or Paxil should be done gradually, according to Wyeth and the FDA.

One reason for the increased suicide reports could be that the medicines are not helping certain children suffering from major depression, said Dr. Richard P. Malone, a child psychiatrist in Philadelphia.

Another potential reason, Malone said, could be that children are more sensitized to the drugs' effects.

Regardless, he said, the likely impact of the warnings would be reduced prescribing of the drugs in children.

The Wall Street Journal first reported on the Effexor letter in Wednesday's editions.

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Last updated: 10/03/2003 - 07:17 AM