Change Suicide Warning On Antidepressants FDA Asks Drug Makers

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Main Category: Depression
Also Included In: Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist;  Psychology / Psychiatry
Article Date: 03 May 2007 - 0:00 PDT

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The US Food and Drug Administration (FDA) has asked makers of all antidepressant drugs to change the existing "black box" labels on their products to warn about increased risk of suicidality (suicidal thinking and behaviour) among young adults aged 18 to 24 in the first few weeks of treatment.

The FDA has also asked the drug companies to revise the existing warning to show there is no evidence this risk exists for adults over 24, and indeed for those aged 65 and older the scientific data suggests the suicidality risk is decreased.

The update request is welcomed by psychiatrists and other health professionals.

The American Psychiatric Association (APA) said:

"The FDA's new labeling acknowledges, for the first time, that untreated depression puts people at risk for suicide."

They said studies showed that the old label issued in 2004 was associated with a steep drop in use of antidepressants and was followed by an increase in the rate of suicide "reversing a decade-long decline in suicide deaths in the United States".

The FDA said the emphasis on the new labels should be that depression and other serious psychiatric illnesses are themselves the most important causes of suicide.

Director of FDA's Center for Drug Evaluation and Research, Dr Steven Galson said yesterday that:

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products."

"Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks," he explained.

The FDA recommends that people who are currently taking antidepressants should not stop taking them as a result of hearing this news. If you are worried about it, talk to your doctor, is their advice.

The warning revision applies to all antidepressants and comes in the wake of controlled trials that showed a reasonably consistent risk of suicidality across most of the antidepressant drug categories. The FDA said that the evidence does not support excluding any antidepressant medication from this update request.

This update request follows the labelling changes made in 2005 to warn of increased suicidality in children and adolescents taking antidepressants.

Since then, the FDA undertook a comprehensive review of 295 drug trials examining the risk of suicidality among adults taking antidepressants.

The trials included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric conditions.

The results was that in December last year, the FDA's Psychopharmacologic Drugs Advisory Committee said labels should be changed to tell doctors about the increased risk of suicidality among younger adults taking antidepressants.

The Committee also said the labels should remind doctors that the disorders themselves present the greater risk, and that among older adults the antidepressants do not carry the suicidality risk and have an apparent beneficial effect.

The FDA is preparing drafts of patient guides and wording for the labels. The manufacturers have 30 days to submit their own versions for FDA review.

The drugs affected include:

-- Anafranil (clomipramine)
-- Asendin (amoxapine)
-- Aventyl (nortriptyline)
-- Celexa (citalopram hydrobromide)
-- Cymbalta (duloxetine)
-- Desyrel (trazodone hydrochloride)
-- Elavil (amitriptyline)
-- Effexor (venlafaxine hydrochloride)
-- Emsam (selegiline)
-- Etrafon (perphenazine/amitriptyline)
-- fluvoxamine maleate
-- Lexapro (escitalopram hydrobromide)
-- Limbitrol (chlordiazepoxide/amitriptyline)
-- Ludiomil (maprotiline)
-- Marplan (isocarboxazid)
-- Nardil (phenelzine sulfate)
-- nefazodone hydrochloride
-- Norpramin (desipramine hydrochloride)
-- Pamelor (nortriptyline)
-- Parnate (tranylcypromine sulfate)
-- Paxil (paroxetine hydrochloride)
-- Pexeva (paroxetine mesylate)
-- Prozac (fluoxetine hydrochloride)
-- Remeron (mirtazapine)
-- Sarafem (fluoxetine hydrochloride)
-- Seroquel (quetiapine)
-- Sinequan (doxepin)
-- Surmontil (trimipramine)
-- Symbyax (olanzapine/fluoxetine)
-- Tofranil (imipramine)
-- Tofranil-PM (imipramine pamoate)
-- Triavil (perphenazine/amitriptyline)
-- Vivactil (protriptyline)
-- Wellbutrin (bupropion hydrochloride)
-- Zoloft (sertraline hydrochloride)
-- Zyban (bupropion hydrochloride)

The APA said:

"We believe the new label, which still contains important warning information, reminds physicians and patients that antidepressants save lives. Physicians and patients need all the facts in order to make appropriate, informed decisions about any proposed course of treatment."

Click here for FDA.

Click here for A-Z of drugs on the Internet Drug Index (RxList, run by WebMD, commercial site).

Written by: Catharine Paddock
Writer: Medical News Today


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