By LINDA A. JOHNSON
The Associated Press
9/3/2003, 6:11 p.m. ET

TRENTON, N.J. (AP) — Wyeth warned doctors that tests showed its antidepressant Effexor caused an increased risk of suicidal behavior in children.

In what is known as a "Dear Doctor" letter, Madison-based Wyeth is telling health professionals that clinical studies of the long-acting version, Effexor XR, found a higher incidence in children of "hostility and suicide-related adverse events, such as suicidal ideation and self-harm." No children in the tests committed suicide.

"You should be alert to signs of suicidal ideation in children and adolescent patients prescribed Effexor or Effexor XR (and) reassess the benefit-risk balance" for each patient, the Wyeth letter states.

The caution comes after U.S. and British regulators in June said no one under 18 should take GlaxoSmithKline's popular antidepressant Paxil because it could increase a child's risk of suicide attempts. Pediatric patients already taking Paxil were told to stop use gradually, under a doctor's supervision.

The U.S. Food and Drug Administration currently is investigating how newer antidepressants affect children. Even though Eli Lilly & Co's Prozac is the only antidepressant approved for treating children some doctors are prescribing other medicines for patients under 18. That's why the FDA has asked makers of antidepressants to submit data from any studies they have done on their safety and effectiveness in children.

"We have not reached a final conclusion" on whether restrictions are appropriate, FDA spokeswoman Susan Cruzan said Wednesday.

She noted many antidepressant makers have been testing them on children under an FDA initiative that grants drug companies an extra six months' marketing exclusivity for doing so.

Wyeth's Aug. 22 letter, written by Dr. Victoria Kusiak, North American medical director for Wyeth Pharmaceuticals, said that in a study of Effexor XR's use against major depression, 2 percent of the children reported thoughts about suicide, versus none in a comparison group getting a dummy pill. Additionally, 2 percent displayed hostility, more than double the rate in those getting a placebo. In a study of patients under 18 with generalized anxiety disorder, 1 percent displayed abnormal or changed behavior; none did so in the comparison group.

Wyeth sent the letter to thousands of psychiatrists, general practitioners, other physicians and pharmacists, spokesman Doug Petkus said.

"We shared information with the FDA. We thought it was the prudent course to provide information in a `Dear Doctor' format," Petkus said.

The letter notes that the studies did not show Effexor relieves depression or anxiety in children.

Effexor was first approved in 1993; along with the once-a-day Effexor XR, it now generates $2.1 billion in annual sales for Wyeth, making it the company's biggest selling drug.

Independent pharmaceutical analyst Hemant Shah of HKS & Co. in Warren, N.J., said that because the pediatric safety question involves all antidepressants, it shouldn't hurt sales of Effexor.

"It's been perceived to be a superior drug to other antidepression agents, so I think it will continue to do well," Shah said.

Wyeth shares closed up 3 cents at $44.35 on Wednesday on the New York Stock Exchange.

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On the Net: http://www.wyeth.com/