F.D.A. Seeks Suicide Caution for Ten Antidepressants

NY Times ^ | March 22, 2004 | NA

[neverdem]

WASHINGTON (AP) -- Patients on some popular antidepressants should be closely monitored for warning signs of suicide, the government warned Monday in asking the makers of 10 drugs to add the caution to their labels.

Although the Food and Drug Administration's investigation into the possible suicide connection initially focused on children given the drugs, its warning is aimed at both adult and pediatric use of the pills to alleviate depression.

It isn't clear yet that the drugs actually do lead to suicide, the FDA stressed. After all, depression itself can lead to suicide.

But until that is settled, advisers to the FDA called last month for stronger warnings to doctors and parents that the antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects.

On Monday, the FDA followed its advisers' recommendation and issued a public health advisory putting doctors, patients, families and other caregivers on notice to be particularly vigilant for signs of worsening depression or suicidal thoughts at the beginning of anti-depressant therapy or whenever the dose is changed.

The drugs of concern are all newer-generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin. Most are known to affect the brain chemical serotonin.

British health authorities sounded the alarm last year, saying long-suppressed research suggests certain antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Because only one drug, Prozac, has been proven to alleviate pediatric depression, Britain declared others -- drugs called SSRIs and their close relatives -- unsuitable for depressed youth.

The FDA issued a caution on pediatric use last year, but Monday's action -- especially the addition of the warning to drug labels -- goes significantly further.

Dozens of anguished parents pleaded with FDA in a meeting last month to add such warnings, citing preteens and teenagers who hanged themselves or slashed their wrists shortly after starting the antidepressants. Parent after parent described children who had become extremely agitated or anxious shortly after starting the antidepressants, and seemingly sudden impulses that turned deadly.

Among 25 studies of the suspect medications involving 4,000 children and teens, there were no completed suicides. But 109 patients experienced one or more possibly suicide-related behaviors or attempts, the FDA says.

The studies varied dramatically in what was considered suicidal behavior, making a clear link difficult, FDA scientists have contended. For example, among 19 patients classified as cutting themselves, almost all were superficial, with little bleeding.

Worse, the youths most likely to commit suicide weren't allowed into those studies, so existing data likely won't settle the issue, the FDA's scientific advisers have warned.

Depression occurs in up to 10 percent of youth, and 1,883 10- to 19-year-olds killed themselves in 2001. Some 1.8 million teenagers attempted suicide that year, a quarter of them requiring medical attention, according to Columbia University scientists who are helping the FDA's probe.

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, FDA said.

[Semper Paratus]

Considering that people who take these drugs are sucicidal to begin with this is like saying people who take anti-cholesterol drugs are prone to heart attacks.

[neverdem]

PING

[anniegetyourgun]

I get depressed just thinking about this.

[xJones]

Then don't try Zoloft.

[Doctor Stochastic]

I was thinking about warnings on allergy nostrums that say you may become sleepy and have a sore throat or headache.

[cjshapi]

That's not necessarily true. I've never been suicidal but had been diagnosed with depression. Unfortunately it seems to be hereditary. It's difficult to put into specifics the difference the lexapro has made. More than the talk therapy did. Life isn't all gray and blah anymore. I can laugh and sing with the radio and be happy.

And for those of you who say faith and trying harder should be enough they are not always. Actually I prayed for years to find a way to lift the darkness. The meds have help do this. But I was never, ever close to being suicidal and I resent being summarily categorized that way.

[BossLady]

Many of these kids/people might have been mis-diagnosed and were not suicidal to begin with....using these drugs actually 'makes' them suicidal. Sad isn't it?

[anniegetyourgun]

Heck....I won't even try hayloft. I can't even remember to take a daily vitamin....

[Semper Paratus]

My daughter had been prescribed Prozac then she said it was making her anxious and prone to panic attacks I got it stopped.

[ZinGirl]

One reasoning I heard about a potential risk for suicide for people on these meds was that some people are actually "too depressed" to even consider suicide.....but as the anti-depressant lifts them up a bit, they feel "well enough" to commit suicide.

[codyjacksmom]

Very well said. I have been fighting depression for about five years and have tried many different combinations of medications. The combination I'm on now...Wellbutrin and Effexor...is starting to help, especially now that I've added a med for adult ADD. And I, like you, have tried years of prayer, positive self talk, etc....none of that has helped. Sometimes, meds are the only way.

[codyjacksmom]

"....using these drugs actually 'makes' them suicidal. Sad isn't it?"

That is very true. When I was diagnosed with panic disorder about ten years ago, I was put on high doses of Buspar. I got suicidal and homicidal. I took myself off of that immediately.

[EggsAckley]

I hate it when they put out an article like this BEFORE they even do the study. Typical. Scare everyone FIRST, then discover that it's not so bad.

Remember apples and alar?

[cjshapi]

I think tomorrow I'm gonna take my pills after I eat a half pound of bacon cooked in a half pound of butter. I'm not sure what else I have in the house that's REALLY bad for me but there's probably something.

Thank goodness I'm not taking my Allegra yet. They'll probably come out with something stating it will probably grow untamed patches of hair on my chest (which ain't so attractive on a woman!)

[BossLady]

Unfortunately, this does not surprise me. I'm glad you were vigilant enough to take your daughter off of the drug as soon as possible.

[BossLady]

I'm so glad you were able to realize what was happening to you. I'm sure it was scarey! I hope you are doing well now!! ;)

[codyjacksmom]

"I hate it when they put out an article like this BEFORE they even do the study. Typical. Scare everyone FIRST, then discover that it's not so bad."

Yeah, it is a bit much. Thankfully I've been on mine long enough to know that they don't affect me that way. And I take two on the list.


"Remember apples and alar?"

No, what's that?

[codyjacksmom]

"I'm so glad you were able to realize what was happening to you. I'm sure it was scarey! I hope you are doing well now!! ;)"

The final straw was when my husband was gone on a trip. I could hardly stop my thoughts of killing my three girls and then myself. I did find out much later that the dose my Doctor had me on was extremely high. No other doctor could believe it was prescribed. Needless to say, I have a different doctor now and I am doing very well. Thank you for your concern. I normally wouldn't share this much on a thread, but this is such an extremely important topic and I hope that it helps someone else if they have these types of reactions.

[DJtex]

"too depressed" to even consider suicide...

I was listening to NPR morning--to get my blood pressure up. They were talking about the tragic suicide of Spaulding Gray. A psychoanalyst who was a close friend of his said this exact thing--that Spaulding got calm and collected at the end, then jumped into the East River.