Antidepressants under FDA scrutiny
WASHINGTON – Tom Woodward’s 17-year-old daughter Julie committed suicide by hanging herself. He blamed the antidepressant that the teen had been taking for seven days.
“We are certain that Zoloft killed our daughter,” said Woodward, one of more than 70 speakers enveloping federal health advisers Monday in an outpouring of emotion, tears and anger.
Others witnesses, like Cynthia Wainscott, urged the Food and Drug Administration not to take away drugs that have reduced suicide rates among depressed youths.
Two FDA advisory panels are considering whether agency action – including stronger warning labels – is needed on antidepressants because they have been linked to suicidal tendencies among children who take them. The joint panel will weigh the benefits of nine drugs given to depressed children against the risk that the remedies may increase suicidal thoughts and actions.
“Drug companies have purposely deceived the public about the safety and efficacy of their drugs,” Woodward said, calling for a strong, black warning on packaging for popular antidepressants.
Susan Bro, spokesman for Zoloft manufacturer Pfizer, would not comment on Woodward’s allegations because of pending litigation. Zoloft, she said, is a “safe and effective drug when used as prescribed.”
Wainscott showed panel members a photograph of her granddaughter Jessi, who she said began suffering from depression at age 11. Now 15 and on medication, Jessi has returned to her normal self, her grandmother said.
“Tell them not to do anything that will make people afraid to go for help,” Wainscott said Jessi told her. Wainscott, chair of the National Mental Health Association, quoted her granddaughter as saying antidepressants meant “there are no invisible strings pulling me down.”
Tarek Hammad, an FDA senior medical reviewer, told the panel an additional 2 percent to 3 percent of children are likely to incur increased suicidal thoughts from taking any antidepressant.
He told reporters that looking at all the drug company studies created a complete picture. “Then, you can see significant findings,” Hammad said.
Relative risks of suicidal behavior or thoughts were highest among youths taking Luvox, Effexor and Paxil and lower among youths taking Celexa, Zoloft and Prozac.
Untreated depression is a serious illness that threatens the children’s lives, said Dr. Laurence Greenhill, speaking on behalf of the American Academy of Child and Adolescent Psychiatry, which represents 7,000 child psychiatrists. He said he found it reassuring that the FDA’s detailed analysis did not find a single completed suicide among 4,440 depressed youth in drug company-sponsored clinical trials.
FDA epidemiologist Andrew Mosholder, who pushed for the closer look at suicidal behavior among children taking antidepressants, noted a clustering of serious events involving suicide within the first four days after youths discontinued Paxil treatment.
Mosholder was praised by grieving family members for requesting clarification last year from Paxil manufacturer GlaxoSmithKline. The data he received in May 2003 suggested a link between Paxil and increased suicidal acts among children taking it.
Dr. Robert Temple, director of the FDA’s office of drug evaluation, told reporters he had no regrets delaying the testimony at a previous hearing because he still thinks Mosholder’s data may be flawed.
Temple said it was “interesting and persuasive” that studies link all antidepressants to heightened suicidal thoughts and actions among youth. “They all lean the same way, including Prozac now,” he said.
In about one-quarter of 200 studies on about 100 pharmaceutical products, the FDA changed the dosages for children, found new adverse reactions that occurred only among children or found the drugs didn’t work in kids at all.