Sept. 14 (Bloomberg) -- Antidepressants may increase the risk of suicidal behavior in children, and manufacturers including Pfizer Inc., Wyeth and GlaxoSmithKline Plc should be required to put stronger warning labels on their drugs, a U.S. advisory panel said.

A Food and Drug Administration commission voted 25-1, with one abstention, to find that antidepressants may raise the risk of suicidal behavior in children and teenagers. The panel voted 27-0 to tell the agency that risk warnings should be strengthened for all nine drugs in the review. The voting came during two days of hearings in Bethesda, Maryland.

``This kind of issue tends to put a cloud over antidepressants,'' said Robert Essner, chief executive of Wyeth, at a Bear Stearns Cos. investors conference this morning in New York. Madison, New Jersey-based Wyeth's Effexor is the world's No. 1-selling antidepressant and isn't approved for use in adolescents.

Drugmakers have come under pressure to disclose tests suggesting a rise in suicidal behavior, which can range from attempting suicide to telling a doctor of wanting to do so. Glaxo, Europe's largest drugmaker, in August settled a lawsuit filed by New York Attorney General Eliot Spitzer over the reporting of safety data on the antidepressant Paxil.

Public Registries

The Washington-based Pharmaceutical Research and Manufacturers of America, a trade group of drugmakers, said it will publish members' drug studies on a Web site starting Oct. 1. The American Medical Association, the largest U.S. medical trade organization, in June called for a mandatory database of all study findings, and editors of a dozen leading medical journals worldwide said Sept. 8 they will require all drug studies to be listed publicly before they will publish findings.

The FDA will take the panel's recommendations into account as it decides whether to require more cautions on antidepressants, including New York-based Pfizer's Zoloft, Wyeth's Effexor and Brentford, England-based Glaxo's Paxil. Parents need more warnings about risks for children and teenagers, an adviser to the agency said.

``The public is asking us very succinctly to warn them,'' said Jean Bronstein, a nurse from Sunnyvale, California, who serves on the FDA's advisory panel.

U.S. doctors wrote almost 11 million prescriptions for children and teenagers in 2002, the FDA said, citing data from Fairfield, Connecticut-based IMS Health Inc., a drug-industry consultant. U.S. sales of the newest kinds of antidepressants rose 12 percent to $10.9 billion last year, according to IMS.

Drugs in Review

The nine drugs in the FDA panel's review include Zoloft, Eli Lilly & Co.'s Prozac, Glaxo's Paxil and Wellbutrin, Forest Laboratories Inc.'s Celexa, Wyeth's Effexor, Akzo Nobel NV's Remeron, the generic medicine nefazodone and Solvay SA's Luvox, which doesn't sell it in the U.S.

Bristol-Myers Squibb Co., the developer of nefazodone, has stopped selling the drug. The generic form of Luvox is sold in the U.S. by other companies for obsessive-compulsive disorder. While Luvox isn't approved in the U.S. as an antidepressant, doctors use it as one, FDA officials said.

Pfizer shares fell 1 cent to $32.12 at 4:17 p.m. in New York Stock Exchange composite trading. Wyeth shares rose 3 cents to $38.73; Forest shares gained $2.09, or 4.9 percent, to $44.60; Lilly shares climbed $1.01, or 1.5 percent, to $66.46; and American depositary receipts of Glaxo increased 71 cents to $42.86, or 1.7 percent. One ADR represents two ordinary shares.

ADRs of Akzo rose 49 cents to $34.88, or 1.4 percent, in Nasdaq Stock Market composite trading. One ADR equals one ordinary share.

FDA Reviewer's Work

Research in children and teenagers found suicidal behavior more common in those taking antidepressants than in those taking a placebo, the FDA determined. No completed suicides occurred in the studies.

The panel's findings support the work of FDA reviewer Andrew Mosholder, who raised the question of the risk of suicidal behavior. FDA officials stopped Mosholder from presenting his research at a February meeting.

``The FDA needs to address the charge that it doesn't have all the data,'' said FDA panel member Judith R. O'Fallon, emeritus professor of biostatistics at the Mayo Clinic. She said the agency must make sure companies don't hide poor results from their studies.

Doctors should weigh antidepressants' risk for causing increased suicidal behavior against their potential for easing depression, said Thomas Laughren, team leader for the FDA's psychiatric drug products group, at the meeting.

Two or three patients of every hundred who are treated with antidepressants may be more likely to exhibit suicidal behavior than those who don't take the medicines, Laughren said.

Doctors' Calculus

The FDA has cleared only Eli Lilly's Prozac for use in children and teenagers. Other medicines have failed in testing to prove that they can ease depression. Approved antidepressants also often don't succeed in studies to show a benefit for adults, so the lack of evidence for antidepressants' effect in children doesn't mean they don't work, FDA officials said.

``Doctors must balance the risk against the benefit'' in treating depression in children, said Laughren said. ``That's the kind of calculus that a clinician has to do.''

The U.K. Medicines and Healthcare Products Regulatory Agency last year recommended against most antidepressants for children, except Prozac. European Union regulators in April recommended that Paxil not be given to children and adolescents because of the risk of suicidal behavior and recommended strengthening warnings about withdrawal symptoms.

To contact the reporter on this story: Kerry Dooley in Bethesda, Maryland kdooley@bloomberg.net.

Last Updated: September 14, 2004 16:33 EDT