http://www.philly.com/mld/philly/business/6685662.htm
Posted on Thu, Sep. 04, 2003
Wyeth issues warning about Effexor
By Linda Loyd
Inquirer Staff Writer
Wyeth has become the second pharmaceutical company to warn health-care
professionals in recent months that a popular antidepressant drug poses
increased risk of suicidal thoughts in children and teenagers.
In a letter dated Aug. 22, Wyeth told thousands of physicians that its drug
Effexor was not effective in treating depression among children and teens, and
that the drug may increase hostility and suicidal thoughts and behavior in
children ages 6 to 17.
Effexor is one of Wyeth's top-selling drugs, with $2.1 billion in worldwide
sales last year. Wyeth is based in Madison, N.J., with its global
pharmaceutical headquarters in Upper Providence Township, Montgomery County.
Like most other antidepressants, Effexor is not approved for use in children,
only in adults.
But many doctors prescribe antidepressants for children anyway.
"We learned of this information after evaluating some clinical studies. We felt
that it was important information that needed to be provided to medical
practitioners," Wyeth spokesman Doug Petkus said.
Wyeth's letter, from Victoria Kusiak, vice president for global medical
affairs, said that among adolescents and children who took Effexor, "there were
increased reports of hostility and, especially in major depressive disorder,
suicide-related adverse events such as suicidal ideation and self-harm."
Similar concerns have been raised about safety in children and teens of
GlaxoSmithKline P.L.C.'s top-selling drug, Paxil.
In June, health authorities in Britain warned doctors against prescribing Paxil
to children with depression, saying studies by Glaxo showed that the medicine
appeared to increase the risk of suicidal thinking and suicide attempts.
The U.S. Food and Drug Administration announced in June that it was reviewing
the safety data, and recommended that Paxil not be used in anyone under 18 for
treating depression.
The FDA is reviewing the safety of antidepressants for children, and has "not
reached a final decision at this time," FDA spokeswoman Susan Cruzan said. "We
are continuing to look at Paxil and the other drugs for depression. We are
taking a look at all the studies in children."
Glaxo, which has a U.S. headquarters in Philadelphia, sent letters to doctors
in Britain and Ireland in June warning that the drug may increase suicidal
thoughts among children and adolescents.
In July, Connecticut's Department of Children and Families became the first
state to ban Paxil for children who are in the state's care and are being
treated for depression.
Wyeth, in the two-page letter to physicians, said clinical studies showed that
2 percent of children on Effexor had suicidal thoughts, compared with none on a
placebo. No suicides were reported in the trials. Wyeth would not disclose how
many children participated in the studies.
Effexor is a serotonin and norepinephrine reuptake inhibitor, or SNRI, that
works by inducing chemical changes in the brain. It is similar to a class of
drugs called selective serotonin reuptake inhibitors, or SSRIs, that includes
Paxil, Prozac and Zoloft.
Prozac is the only antidepressant with FDA approval for use in children.
In the late 1990s, pharmaceutical companies were given six-month extensions on
patents for certain medicines, including antidepressants, if they studied in
clinical trials their drugs' effects on children.
Glaxo conducted nine clinical trials of Paxil in children between 1998 and
2002, spokeswoman Mary Anne Rhyne said.
Among the more than 1,000 children taking Paxil in the studies, 3.4 percent had
"suicidal thinking or suicide attempts" while on the drug and during a 30-day
follow-up period, compared with 1.2 percent of children taking a placebo,
Glaxo's Rhyne said. No cases of suicide were reported in the studies, she said.
Paxil, sold in Europe as Seroxat, is Glaxo's second-top-selling drug, with $3.1
billion in worldwide sales last year. Paxil prescriptions for children are a
"very small percent of sales, in the low single digits," Rhyne said.
Wyeth said it did not know how much of Effexor's $2.1 billion in sales last
year was for children.