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FDA - Warnings on labels for antidepressants recommended

Tuesday, March 23, 2004

WASHINGTON -- Doctors who prescribe some popular antidepressants should monitor their patients closely for warning signs of suicide, especially when they first start the pills or change a dose, the government warned Monday.

The Food and Drug Administration asked makers of 10 drugs to add or strengthen suicide-related warnings on their labels.

The agency insists it's not yet clear whether the drugs actually spur suicide on occasion -- or whether the underlying mental illness is to blame. But FDA bowed to pressure from anguished families who, at an emotional meeting last month, blamed the pills for their loved ones' suicides and pleaded for better warnings.

It's a difficult issue to sort out because depression itself can lead to suicide, and studies clearly show that antidepressants have helped many people recover from depression.

Still, until the question is settled, FDA's own scientific advisers had urged stronger warnings that certain antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be more prone to rare side effects.

Monday, FDA followed that recommendation, stressing that the most vulnerable time is when a patient starts therapy or changes the dose.

While FDA's investigation into the possible suicide link initially focused on children and teenagers, Monday's warning includes adults, too. The FDA had investigated reports of suicide among adult antidepressant users in the early 1990s and concluded there was no link -- but on Monday revealed that it is reanalyzing that question.

The drugs of concern are newer generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro, Luvox, which are called SSRIs or SSRI-like drugs, and Remeron, Serzone and Wellbutrin, which operate differently.

Manufacturers didn't immediately say if they'd comply.

British health authorities sounded the alarm last year, saying long-suppressed research suggests serotonin-affecting antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Excepting only one drug, Prozac, that has been proven to alleviate pediatric depression, Britain declared the other six SSRIs or SSRI-like drugs unsuitable for depressed youth. Britain didn't mention the other three drugs listed in the U.S. notice.

FDA issued a caution on pediatric use last year but says it doesn't yet have proof the drugs are to blame.

Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. Some 109 patients experienced one or more possibly suicide-related behaviors or attempts -- but the studies varied dramatically in what was considered suicidal behavior. For example, among 19 patients classified as cutting themselves, almost all were superficial, with little bleeding.

But critics flooded an FDA meeting last month demanding stronger action -- and days later, the issue again made headlines when a 19-year-old woman taking part in a study of Eli Lilly & Co.'s experimental new antidepressant duloxetine hanged herself in a company-run facility.

Most antidepressant labels already contain some fine-print statement about suicide, usually that the possibility is inherent with depression.

FDA asked Monday for explicit explanations of worrisome behavior changes to be placed in bold print under the prominent "warnings" section of those labels: agitation, anxiety, irritability and recklessness. Doctors spotting those traits should consider prescribing a lower dose or stopping the drug, FDA said.

The drugs are used for many conditions other than depression; the warning applies regardless of the reason for use.

Critics welcomed the change but said suicide complaints first were raised many years ago.

"I'm just very sorry that it so long for them to act on this issue, because there's been so much tragedy that occurred," added Jennifer Tierney of Kernersville, N.C., who describes her daughter Jame as turning from a sweet, popular honor student into a raging loner after taking Effexor for migraines at age 14.

But psychiatrists caution that suicides have dropped as SSRI use has increased round the world.

"We do a disservice to a population of people who could benefit from these medications" by overreacting, said Dr. Bela Sood, chair of pediatric psychiatry at Virginia Commonwealth University.

Still, FDA's warning does alert doctors "who in a very lackadaisical way decide to put these kids on medications" to do a more thorough exam -- and to tell parents what risks to watch for, Sood said.

Children in particular aren't good candidates for SSRIs if they're highly impulsive, angry or aggressive, she said. There also is a window period of risk just after pill use begins, before depression is really alleviated but when some patients experience more energy.

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On the Net:

FDA: http://www.fda.gov


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