Parents cite pros, cons of SSRI drugs
FDA hears testimony on drugs' possible link to suicides by the young
WASHINGTON -- In the start of an emotional public debate on whether adult antidepressants should be given to children, the US Food and Drug Administration yesterday heard appeals from parents who blame the pills for their children's suicides, as well as from families who credit the pills with saving their children.
British health authorities sounded an alarm on antidepressants last year, saying long-suppressed research suggests certain popular depression drugs might sometimes increase the risk of suicidal behavior in children and teenagers.
Now the FDA is wrestling with whether the suicide risk is real, and if so, what to do. It's a difficult decision because depression itself can lead to suicide.
The FDA's focus is a family of drugs known as selective serotonin reuptake inhibitors, or SSRIs. They make up the popular class of antidepressants that includes Prozac. Among 25 studies of the suspect medications involving 4,000 young people, there were no completed suicides. But 109 patients experienced one or more possibly suicide-related behaviors or attempts, FDA medical reviewer Dr. Thomas Laughren said yesterday.
The problem, he said, is that studies varied dramatically in what was considered suicidal behavior. Among 19 patients classified as cutting themselves, for instance, almost all were superficial, with little bleeding.
Still, "there's obviously something going on here," Laughren said at yesterday's meeting, called to update the agency's scientific advisers on the debate.
The FDA has hired Columbia University to help determine exactly how much suicidal behavior occurred in studies of the drugs, before it decides its next steps by late summer. Meanwhile, the FDA is warning doctors to use great caution in prescribing any antidepressant other than Prozac to people under 18.
But dozens of anguished parents pleaded with the FDA yesterday to put warnings of the possible suicide risk on the drugs' labels as soon as possible. Over and over, they described youths becoming extremely agitated after starting the pills, and acting on seemingly sudden impulses that turned deadly.
"You have an obligation today . . . from preventing this tragic story from being repeated over and over again," said Mark Miller of Kansas City, Mo., whose 13-year-old son, Matt, hanged himself in his bedroom closet after taking his seventh Zoloft pill.
"For FDA to continue to sit on this information . . . is a gross misuse of power," said Robert Fritz of New Jersey, whose daughter Stephanie hanged herself after finishing her homework and excitedly discussing an upcoming singing performance. She used Zoloft.
When Effexor patient Justin Cheslek hanged himself at college, "beneath him was a laptop and a glass of Coke. It was as if some sudden impulse made him do this," said his father, Gary Cheslek, of Vicksburg, Miss.
Some families said they believed that the drugs caused violent behavior.
"These drugs are hell. Look what they've done to my son," say Jay Baadsgaard after his son Corey described taking Effexor and then waking up in jail, claiming no memory of holding his Mattawa, Wash., class hostage at gunpoint four years ago.
But a few parents, despite boos from the crowd, credited the drugs with saving their children.
"I ask that you appreciate the enormous benefit these medicines have had," said Sherri Walton of Arizona, whose 14-year-old daughter, Jordan, has used SSRIs in a years-long battle with obsessive-compulsive disorder and depression. "Her medicines were sometimes the only things she could depend on to help her."
"I shudder to think of their plight if these medicines were not available," added Suzanne Vogel-Scibilia of the patient group National Alliance for the Mentally Ill. She said the drugs dramatically improved depression in two of her teen sons, including one who had attempted suicide.
FDA files show 110 reports of suicides among youths taking any of 10 antidepressants since they hit the market more than a decade ago. But the difficulty of knowing what led to a suicide has the agency depending on studies, not death reports or family experiences, to decide the issue.
"To err in either direction has significant consequences," said Laughren, worried that warnings that overstate the possible risk would dissuade patients from potentially helpful treatment.
Depression occurs in up to 10 percent of young people, and 1,883 10- to 19-year-olds killed themselves in 2001. About 1.8 million teenagers attempted suicide that year, a quarter of them requiring medical attention, said Dr. David Schaffer of Columbia University.
In 2002, almost 11 million prescriptions were dispensed to patients under 18 for SSRIs and other newer antidepressants, to treat depression and a host of other conditions, the FDA said.