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Study confirms link between antidepressants and suicide

Drugs much riskier for kids than what was once thought, scientists say
Friday, April 23, 2004
BY ED SILVERMAN
Star-Ledger Staff

For the first time, a study has compared previously undisclosed data about four antidepressants with published medical findings, and found the drugs pose a risk to children.

The results are the latest confirmation that several popular medicines used to treat children for depression are riskier than previously known and may lead to suicide. The study appears in the latest edition of the Lancet, the British medical journal.

After reviewing the data, researchers wrote the risk of children taking Paxil, Zoloft, Celexa and Effexor outweighed the benefits.

For instance, an unpublished Effexor study by Wyeth, its manufacturer, revealed 14 suicidal events, compared with just one in a published study. And published data on Zoloft by Pfizer omitted information showing twice as many suicidal events, according to a scientist who helped conduct the Lancet study.

"These drugs appear not to be any better than placebo," said Tim Kendall of the National Collaborating Centre for Mental Health in London, who co-authored the study at the request of U.K. medical authorities. "And there might well be an increased risk of suicide."

A spokesman for Wyeth said Effexor should never be prescribed to children. Spokespeople for Glaxo, which markets Paxil, and Pfizer didn't return calls seeking comment. Forest Labs, which makes Celexa, couldn't be reached.

The study appears amid a widening controversy over antidepressants that has engulfed the Food and Drug Administration, several of the world's biggest drug makers and a growing number of families around the country that want the use of these medicines restricted.

The controversy, however, is not straightforward.

Many doctors and their patients argue antidepressants save lives. And though an increasing number of children are prescribed antidepressants, only Prozac was ever approved for children in the United States. The growth reflects off-label usage, a common practice among doctors to write prescriptions even though regulators have not approved a medicine for a specific use.

Nonetheless, the issue has prompted congressional investigations that are attempting to shine a spotlight on the FDA's internal review procedures. It has opened a debate over access to unpublished clinical-trial data, which may include unflattering information about a drug.

"The story of research into antidepressant use in childhood depression is one of confusion, manipulation and institutional failure," The Lancet wrote in an editorial accompanying the study.

The unpublished clinical trial data was first disclosed last year after U.K. medical authorities demanded the information from drug makers. Consumer advocates say the risks found in that data underscore the need to have access to such information.

"Doctors have been getting false information," said Vera Sherav of the Alliance for Human Research Protection in New York. "And when you have misinformation about the safety and benefits of a medical treatment, you're putting people at risk."

Last month, the FDA asked drug makers to place warnings on labels that the pills may cause suicidal thoughts. But the agency was criticized by politicians and families for failing to follow the lead of British medical authorities, who urged doctors not to prescribe the drugs to children.

The agency has also been accused of muzzling one of its own medical reviewers, who wants to restrict the use of antidepressants in children, but was prevented from making his recommendation at a meeting two months ago. Last week, the FDA, which has asked Columbia University to analyze all clinical trial data, denied the charges.

One New Jersey parent yesterday said the Lancet findings were eye-opening.

"This tells a completely different story and I'm happy this was done," said Laurie Yorke of Clark, whose son twice attempted suicide while on Paxil. "Parents want to be given information they need. If you're not told a risk is there, you're not going to look for it."




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