Medicines suspected in youth suicides

FDA split over issuing antidepressant warning

February 03, 2004|By Julie Bell | Julie Bell,SUN STAFF

BETHESDA - Some Food and Drug Administration reviewers already believe there is enough evidence to show several of the most popular antidepressants cause suicidal behavior in some youths, an FDA division chief said yesterday.

But Dr. Russell Katz, head of the agency's neuropharmacological drugs division, told an FDA advisory committee reviewing the safety of antidepressant drugs in children that most in the FDA want to finish a review of recent drug trials in children before reaching a conclusion.

Several members of the advisory committee responded, however, that warnings about the use of drugs in children are appropriate now, though the panel didn't take an official vote.

"Our sense is that we would like, in the interim, for the FDA to go ahead and issue stronger warning indications" about potential risk, said Dr. Matthew Rudorfer, a doctor at the National Institutes of Health who was panel chairman.

Some committee members said they are skeptical that the agency will get the information it needs even when it finishes the review, which relies on data provided by pharmaceutical companies. Those companies tested the drugs in children in exchange for patent extensions that collectively reaped them billions of dollars.

To win the extensions, the companies didn't have to prove the drugs were effective in children - only that they completed the drug trials according to FDA specifications. Some FDA staff and committee members therefore question whether those trials might have subtle biases or other flaws.

The testing also wasn't designed to examine whether the drugs might cause some patients to become suicidal.

"I'm concerned that no amount of analysis of a flawed data set will answer the question," said Dr. Robert J. Fink, a Dayton, Ohio, lung specialist who is a member of the expert committee that advises the FDA on pediatric drug issues.

Yesterday's meeting also included testimony from dozens of researchers, doctors and relatives of children who have used antidepressant drugs.

Many bereaved family members walked up to the microphone clutching photographs of loved ones, who they said became suicidal only after taking the drugs. But others countered that they believe taking the drugs had saved their lives.

One expert pointed to a reduction in the rate of completed suicides that corresponded to the proliferation of the drugs - most of which are selective seratonin reuptake inhibitors, SSRIs - in the late 1980s.

"After going up for 35 years, teen suicide rates have been declining consistently in many countries," said Dr. David Shaffer of the New York State Psychiatric Institute. Noting that the use of SSRIs also increased during that time, Shaffer said: "These trends could be related."

The FDA called the meeting to get advice on how to proceed with a review that so far has been unable to answer the question of whether the nine antidepressants - Prozac, Zoloft, Paxil, Luvox, Celexa, Wellbutrin, Effexor, Serzone and Remeron - are causing suicidal behavior in some children who take them.

British health authorities, apparently looking at the same information, warned in early December that all but one in a class of related antidepressive drugs are unsuitable for children under 18. The exception is Prozac, which is also the only drug approved for major depression in children in the United States. Doctors are permitted to prescribe any medication for children as long as it has been approved for adults.

The FDA, concerned about depriving children of a drug that might be helping many while hurting a few, so far has balked at issuing similar strong warnings. It instead alerted doctors in October that there have been reports of suicidal thinking and suicide attempts in clinical trials involving some of the antidepressants, though none of the trials reported suicides.

"We stopped short ... of saying `Don't you dare use this,'" Dr. Robert Temple, the FDA's director of medical policy, told reporters last week. "Pediatric depression is a very lethal disease all by itself."

U.S. sales of antidepressants totaled $12.5 billion in 2002, according to Decision Resources Inc. of Waltham, Mass. About $5.2 billion of those sales were for major depression, with the newer classes of popular antidepressants that are now part of the FDA review accounting for about $4.1 billion of that.

Outpatient pharmacies dispensed a total of about 2.7 million prescriptions of SSRIs and a handful of other selected antidepressants to children ages 1 to 11 last year, accounting for about 2 percent of the total. Adolescents 12 to 17 years old accounted for 8.1 million of the outpatient prescriptions for the same drugs, the FDA said.

The FDA and many psychiatrists recommend that parents talk with their children's doctors about whether the drugs are appropriate. If parents decide to take a child off the medication, do so gradually, they say.

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