2nd Firm Warns
Against Having Kids Take Its Drug
August 30, 2003
DAVE ALTIMARI And JACK DOLAN, Courant
For the second time in the past
two months, a pharmaceutical company is warning that an
anti-depressant drug should not be prescribed to children
because it may cause suicidal thoughts or
Wyeth Pharmaceuticals Inc., based in New
Jersey, has sent a letter to health care professionals across
the country warning of possible problems with giving Effexor
a two-page letter dated Aug. 22, Dr. Victoria Kusiak, Wyeth's
vice president for global medical affairs, warned that in
recent clinical trials Effexor was not effective in treating
depression or anxiety and that there were increased "reports
of hostility and especially in Major Depressive Disorder,
suicide-related adverse events such as suicidal ideation and
In June, British drug manufacturer
GlaxoSmithKline sent letters to doctors in Britain and Ireland
warning of a similar concern with its well-known
anti-depressant, Paxil. Officials at the U.S. Food and Drug
Administration then advised American doctors not to prescribe
Paxilfor children, citing unpublished studies done by Glaxo
indicating that the drug increases suicidal thinking among
Effexor is used to treat depression and
bipolar disorder and is similar to Paxil, Prozac and
Wyeth spokesman Douglas Petkus said the company
decided to notify health care professionals as a
"Companies typically don't release data
that is sent to the FDA, but in this case we felt it was
important for physicians to be aware of the studies because we
know it is being prescribed to children," Petkus
Petkus said the company is still doing clinical
trials on adolescents. He would not say if Wyeth is trying to
obtain FDA approval to give Effexor to children. Even though
the drugs aren't approved for children, many doctors prescribe
the anti-depressants to them because they have used them
successfully with adult patients.
In the late 1990s,
the FDA offered drug makers a six-month extension on the
patents for certain drugs, including anti-depressants, if the
companies were willing to do clinical trials of their effects
on children, said FDA spokesman Brad Stone.
So far, the
makers of Effexor and Paxil are the only two manufacturers of
anti-depressants who have submitted data pointing to a
potential link between their drugs and increased thought of
suicide in teens, Stone said.
The FDA originally
approved Effexor for use in adults in December of 1993. It is
one of the company's bestselling drugs.
In its letter,
Wyeth points out that there were no suicides in the clinical
trials. The studies were done on children and teenagers 6 to
17. Wyeth did not say how large the study group
But the studies did show that when it comes to
having suicidal thoughts, 2 percent of those on Effexor had
them, compared with none on the placebo. With hostility or
aggressive behavior, the numbers were 2 percent on Effexor and
1 percent on a placebo.
Those numbers are similar to
GlaxoSmithKline's studies on Paxil, which doesn't surprise
"There's no reason why Paxil should be
any different than other drugs in this class. If they analyzed
them all the same way, they would likely get similar results,"
said Dr. Irving Kirsch, a professor of psychology at the
University of Connecticut. Kirsch has done several studies on
the effects of anti-depressant drugs on adults.
said the company may be sending out a notice now because the
FDA is taking a closer look at anti-depressants and their
effects on children after the Paxil studies.
the company would have sent this out without some pressure
from the FDA," said Dr. Leigh Thompson, a former top scientist
who was involved at Eli Lilly with getting Prozac approved by
Thompson runs his own consulting business
assisting drug companies in winning FDA approval.
is now two drugs in this class that seem to have problems when
it comes to children," Thompson said. "I think you'll see the
FDA look closely at this whole field."
Just as Glaxo
did with Paxil, Wyeth officials cautioned that Effexor is not
FDA-approved for children.
"You may need to reassess
the benefit-risk balance when treating individual patients,"
the letter states. "If a decision is made to discontinue a
patient from Effexor, treatment should not be discontinued
abruptly due to risk of discontinuation symptoms."