Suicide Warning Sought for Antidepressants

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http://apnews.myway.com/article/20040322/D81FKEOG1.html

 

 

 

 

Mar 22, 3:06 PM (ET)

By LAURAN NEERGAARD

 

WASHINGTON (AP) - Doctors who prescribe some popular antidepressants should

monitor their patients closely for warning signs of suicide, (sic) 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 unusually 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.

 

" We think this is good advice whether the drugs increase the risk or not, " said

FDA medical policy chief Dr. Robert Temple. " There's a reason people are put on

therapy - their depression is worse or somebody's worried about it. Maybe that's

what drives it (reports of suicides) or maybe it's the drugs. In either case,

you really need to pay attention in the early days. "

 

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.

 

_____________________________

 

On the Net: FDA: http://www.fda.gov

 

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