FDA - all antidepressants need new warning labels

The Food and Drug Administration (FDA) in the United States wants the manufacturers of antidepressant medications to change the labels on their products.

The FDA says all antidepressants should carry new warnings about an increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first few months of treatment.

The proposal will mean current black box warnings on the drugs will be updated to include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality.

The warning will also emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

The FDA says studies have consistently shown a "slight increase" in suicidal thinking and behavior among young adults during early treatment, but the data did not find a higher risk for adults older than 24.

Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, says the proposed action represents the FDA's commitment to a high level of post-marketing evaluation of drug products.

Dr. Galson says depression and other psychiatric disorders can have significant consequences if not appropriately treated and antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks.

Experts advise people currently prescribed antidepressant medications to continue taking them and see their doctor about any concerns they might have.

The proposed labeling changes apply to the entire category of antidepressants and follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants.

At that time the FDA requested manufacturers 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.

The FDA also directed manufacturers to develop FDA-approved Medication Guides, which gave user-friendly information to patients.

The Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Following a comprehensive review in 2005 by the FDA of 295 individual antidepressant trials, in 2006, the FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed.

The review included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, and examined the risk of suicidality in adults who are prescribed antidepressants.

The committee said 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 suicidality.

The FDA has given the manufacturers of antidepressants 30 days to submit their revised product labels and revised Medication Guides to the FDA for review.

Products involved include: Anafranil, Asendin, Aventyl, Celexa, Cymbalta, Desyrel, Elavil, Effexor, Emsam, Etrafon, fluvoxamine maleate, Lexapro, Limbitrol, Ludiomil, Marplan, Nardil, nefazodone HCl, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron Sarafem, Seroquel, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.

For more information go to www.fda.gov/cder/drug/antidepressants/default.htm