OT: Wyeth Warns Of Childrens Suicide Risk With Antdepressant Drug (Effexor)

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Wyeth Warns Of Kid Suicide Risk With Drug

http://www.intelihealth.com/IH/ihtIH/EMIHC251/333/21291/368964.html?d=dmtICNNews

September 4, 2003

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 GlaxoKline'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 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. 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.

Copyright 2003 The Associated Press. All rights reserved.