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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 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."

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