Fwd: [drugawareness] NY Senator Schumer Urges FDA to Act Quickly on Paxil

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Sat, 14 Jun 2003 09:34:11 EDT

[drugawareness] NY Senator Schumer Urges FDA to Act Quickly on Paxil

 

 

 

Yesterday the New Jersey director of the International Coalition for Drug

Awareness joined New York Senator Charles Schumer in a press conference. Senator

Schumer called the conference to urge the FDA to act immediately stop the

prescribing of Paxil to children while they evaluate the nine studies that

spurred

the authorities in the UK to ban Paxil for use in children earlier this week.

 

Lisa was there to support Senator Schumer and to discuss the Paxil - induced

nightmare of her daughter and their pending court case against the drug

manufacturer and doctors and hospitals involved. Her case will also be featured

in

an article in the upcoming issue of Good Housekeeping.

 

Let's hope this will be only the beginning of the official warnings in this

country about the dangers of this very powerful SSRI antidepressant.

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition For Drug Awareness

www.drugawareness.org & author of Prozac: Panacea

or Pandora? - Our Serotonin Nightmare (800-280-0730)

 

 

 

 

FOR IMMEDIATE RELEASE CONTACT: Stu Loeser

June 13, 2003 (917) 647-9187

 

WITH BRITAIN BANNING THE DRUG PAXIL FOR YOUTH, SCHUMER URGES FDA TO EXPEDITE

STUDY OF WHETHER IT INCREASES SUICIDES AMONG KIDS

 

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. "