FOR IMMEDIATE RELEASE: June 13, 2003
WITH BRITAIN BANNING THE DRUG PAXIL FOR YOUTH, SCHUMER
URGES FDA TO EXPEDITE STUDY OF WHETHER IT INCREASES SUICIDES AMONG
Nine British studies of the popular antidepressant show it
causes depressed children to become more suicidal
Schumer also asks FDA to place hold on drugmaker's request to
sell Paxil to children here
Armed with the combined results of nine British studies showing
the popular antidepressant Paxil causes depressed children to become
more suicidal, US Senator Charles E. Schumer today urged the US Food
and Drug Administration (FDA) to expedite its own study – a
necessary step to banning the drug's use for kids in the United
States. Schumer also asked the FDA to place a hold on the drug maker
GlaxoSmithKline's request to the FDA to sell Paxil for children's
use pending the outcome of this study.
"Instead of helping kids overcome their depression, there is more
and more evidence that Paxil makes it worse. The British government
acted decisively to protect children from the risks of this drug,
and the US should do the same," Schumer said.
In a letter
to FDA Commissioner Mark B. McClellan, Schumer cited the move this
week by the British government's Medicines and Healthcare Products
Regulatory Agency – the UK's version of the FDA – to ban sales of
Paxil to youth. The British drug agency declared that it is clear
that the benefits of using Paxil to treat depression in children do
not outweigh the risks. The British government also recently forced
the makers of Paxil to remove a statement on its patient label
saying that the drug was not addictive. Canada and France have also
moved to ban use of Paxil among children.
The nine British studies lasted as long as eight years and
involved more than 1,000 patients between age of 7 and 18. The
studies concluded that patients taking Paxil were 1.5 to 3.2 times
more likely to have suicidal thoughts or episodes of self-harm than
those taking a placebo. The findings also show that Paxil is not
particularly effective in treating depression in youth. The studies
do not make any conclusions about the use of Paxil by adults.
Schumer said that even though Paxil has not been approved in the
United States for treating children, many doctors here prescribe the
drug to them anyway. Despite the British findings, GlaxoSmithKline,
the maker of Paxil and its British version Seroxat, refuses to warn
American doctors against using the drug for depressed children.
Instead, GlaxoSmithKline has applied for permission from the FDA to
sell Paxil to children who suffer from obsessive compulsive
disorder. Schumer also asked FDA Commissioner McClellan to place a
hold on this application pending the results of the FDA study.
Approximately 30.4 million prescriptions for Paxil and Paxil CR
were written in the United States last year, according to the group
NDCHealth, which tracks prescription drug use. Paxil is part of a
class of antidepressant drugs that includes Prozac and Zoloft. Many
patients who have used these drugs contend that they tend to
increase violence and suicidal thoughts in vulnerable populations,
which the makers of the drugs have long denied.
Schumer was joined today by Lisa Van Sycklel. Four years ago, her
teen-aged daughter Michelle complained of feeling sick, was
mis-diagnosed with depression, and was prescribed Paxil. Mrs. Van
Syckel said she quickly saw sweeping changes in her daughter, who
was an honor-roll student who spoke French fluently and had no
history of drug or alcohol abuse. Michelle cut herself dozens of
times with knives, razors and jagged pieces of compact disc cases,
even cutting the word 'die' in her abdomen. Michelle attempted
suicide repeatedly and threatened to kill her mother with an ax.
Eventually, another doctor diagnosed Michelle with Lyme Disease.
Michelle – who turns 18 next week – stopped taking Paxil, and has
returned to a relatively normal life as a high school senior.
Schumer noted that GlaxoSmithKline, the maker of Paxil, is itself
a British company. "The fact that Paxil has been banned for kids in
its home country tells you something. Here in the US we have to act
quickly to make sure that our kids aren't made more suicidal by a
drug that's supposed to do exactly the opposite."