New Warnings Proposed for Antidepressants
On May 2, 2007, FDA proposed new warnings about suicidal thinking and behavior in young adults who take antidepressant medications. The proposed labeling changes apply to the entire category of antidepressants and include:
- Warnings about increased risks of suicidal thinking and behavior in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
- Language stating that scientific data did not show this increased risk in adults older than 24.
- Language stating that adults ages 65 and older taking antidepressants have a decreased risk of suicidal thinking and behavior.
- Emphasis that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
Steps for Consumers
- If you are currently taking prescribed antidepressant medications, you should not stop taking them.
- Notify your health care provider if you have concerns.
Products Involved in FDA's Action
- Anafranil (clomipramine)
- Asendin (amoxapine)
- Aventyl (nortriptyline)
- Celexa (citalopram hydrobromide)
- Cymbalta (duloxetine)
- Desyrel (trazodone HCl)
- Elavil (amitriptyline)
- Effexor (venlafaxine HCl)
- Emsam (selegiline)
- Etrafon (perphenazine/amitriptyline)
- fluvoxamine maleate
- Lexapro (escitalopram hydrobromide)
- Limbitrol (chlordiazepoxide/amitriptyline)
- Ludiomil (maprotiline)
- Marplan (isocarboxazid)
- Nardil (phenelzine sulfate)
- nefazodone HCl
- Norpramin (desipramine HCl)
- Pamelor (nortriptyline)
- Parnate (tranylcypromine sulfate)
- Paxil (paroxetine HCl)
- Pexeva (paroxetine mesylate)
- Prozac (fluoxetine HCl)
- Remeron (mirtazapine)
- Sarafem (fluoxetine HCl)
- Seroquel (quetiapine)
- Sinequan (doxepin)
- Surmontil (trimipramine)
- Symbyax (olanzapine/fluoxetine)
- Tofranil (imipramine)
- Tofranil-PM (imipramine pamoate)
- Triavil (perphenazine/amitriptyline)
- Vivactil (protriptyline)
- Wellbutrin (bupropion HCl)
- Zoloft (sertraline HCl)
- Zyban (bupropion HCl)
Related FDA Actions
- Similar labeling changes in 2005: The proposed labeling update follows similar labeling changes made in 2005 that warned of a risk of suicidal thinking and behavior in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. FDA also directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.
- A comprehensive review of antidepressant trials: Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidal thinking and behavior in adults who are prescribed antidepressants.
- Developing and revising the product labeling: In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidal thinking and behavior in younger adults using antidepressants. The committee also noted that product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidal thinking and behavior. Manufacturers of antidepressants will be submitting their revised product labels and Medication Guides to FDA for review.
For more information about antidepressant use, including the draft labeling and draft Medication Guides, visit www.fda.gov/cder/drug/antidepressants/default.htm.
You can also access questions and answers about the proposed labeling changes at www.fda.gov/cder/drug/antidepressants/QA20070502.htm#3.
Date Posted: May 3, 2007
