Posted By Jim Vititoe on May 2, 2007
FOR IMMEDIATE RELEASE
P07-77
May 2, 2007
Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products’ labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also 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 proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
“Today’s actions represent FDA’s commitment to a high level of post-marketing evaluation of drug products,” said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. “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.”
People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.
The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.
The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk 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. In addition, FDA 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.
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 suicidality in adults who are prescribed antidepressants.
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 suicidality in younger adults using antidepressants. Additionally, the committee noted 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.
FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.
Products involved in today’s action include:
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)
For more information:
Antidepressant use in children, adolescents, and adults, including the draft labeling and draft Medication Guides www.fda.gov/cder/drug/antidepressants/default.htm
FDA’s Psychopharmacologic Drugs Advisory Committee, including transcripts from the December 2006 meeting www.fda.gov/ohrms/dockets/ac/cder06.html#Psychopharmacologic
Categories: FDA
Tags: drug warning
About the author
Jim was born in Oklahoma City, Oklahoma on March 14, 1947. His father was in the military and his family moved to Germany when Jim was 5. In 1956, his family relocated back to the United States and lived in Georgia. In 1965, Jim graduated from Northside High School in Warner Robins, Georgia, where he was President of the Student Body, Honorary Mayor of the Town and selected as Most Versatile Student.
Jim attended the College of William & Mary in Williamsburg, Virginia and graduated with a degree in psychology in 1971. He moved to Hawaii to work for United Airlines and to enjoy his passion for worldwide travel. He also managed to attend the University of Hawaii for a few extra enrichment classes.
In 1973, Jim moved to Los Angeles to attend Southwestern University School of Law. He was on the Dean's List, President of the Student Bar Association, and was the recipient of the prestigious Frederick Graff Award for most outstanding student.
After graduation from Law School, Jim became an associate in the Law Offices of Edward L. Masry. Jim worked for several years as an associate attorney and in 1982 Jim became a partner. The Law Offices of Edward L. Masry was renamed The Law Offices of Masry & Vititoe. Jim married Karen Dutcher in 1984 and they have two children, Justin and Travis.
Over the past 20 plus years, Jim has specialized in civil tort litigation. He has handled thousands of wrongful death cases, work-related injuries, and personal injuries. Typical cases have included auto collisions, product liability, premises liability, medical malpractice, and environmental exposure. Recently, his focus and specialty has been brain injury cases including severe and mild traumatic brain injuries [MTBI].
Jim has received much recognition over his career. He has received the U.S. Congressional Award for Trial Lawyer of the Year in 1990, 1991 and 1992. Consumer Attorneys of California awarded him Trench Soldier of the Year in 1996; Presidential Recognition for Exceptional Contribution in 1996; Outstanding Consumer Advocate in 1997; and the President's Award of Merit in 2000. Trial Lawyers for Public Justice (TLPJ) awarded Jim the President's Award in July 2001 in recognition of his extraordinary work and success in building membership support.
Jim was appointed to the Board of Governors for the Consumer Attorney Association of Los Angeles in 1998. He was appointed to the Board of Governors for the American Trial Lawyers Association, Trial Lawyers for Public Justice, and Consumers Attorneys of California in 2001.
Jim was born in Oklahoma City, Oklahoma on March 14, 1947. His father was in the military and his family moved to Germany when Jim was 5. In 1956, his family relocated back to the United States and lived in Georgia. In 1965, Jim graduated from Northside High School in Warner Robins, Georgia, where he was President of the Student Body, Honorary Mayor of the Town and selected as Most Versatile Student.
Jim attended the College of William & Mary in Williamsburg, Virginia and graduated with a degree in psychology in 1971. He moved to Hawaii to work for United Airlines and to enjoy his passion for worldwide travel. He also managed to attend the University of Hawaii for a few extra enrichment classes.
In 1973, Jim moved to Los Angeles to attend Southwestern University School of Law. He was on the Dean's List, President of the Student Bar Association, and was the recipient of the prestigious Frederick Graff Award for most outstanding student.
After graduation from Law School, Jim became an associate in the Law Offices of Edward L. Masry. Jim worked for several years as an associate attorney and in 1982 Jim became a partner. The Law Offices of Edward L. Masry was renamed The Law Offices of Masry & Vititoe. Jim married Karen Dutcher in 1984 and they have two children, Justin and Travis.
Over the past 20 plus years, Jim has specialized in civil tort litigation. He has handled thousands of wrongful death cases, work-related injuries, and personal injuries. Typical cases have included auto collisions, product liability, premises liability, medical malpractice, and environmental exposure. Recently, his focus and specialty has been brain injury cases including severe and mild traumatic brain injuries [MTBI].
Jim has received much recognition over his career. He has received the U.S. Congressional Award for Trial Lawyer of the Year in 1990, 1991 and 1992. Consumer Attorneys of California awarded him Trench Soldier of the Year in 1996; Presidential Recognition for Exceptional Contribution in 1996; Outstanding Consumer Advocate in 1997; and the President's Award of Merit in 2000. Trial Lawyers for Public Justice (TLPJ) awarded Jim the President's Award in July 2001 in recognition of his extraordinary work and success in building membership support.
Jim was appointed to the Board of Governors for the Consumer Attorney Association of Los Angeles in 1998. He was appointed to the Board of Governors for the American Trial Lawyers Association, Trial Lawyers for Public Justice, and Consumers Attorneys of California in 2001.
Jim is currently a member of the American Trial Lawyers Association, American Bar Association, Trial Lawyers for Public Justice, Consumer Attorneys of California, Consumer Attorneys Association of Los Angeles, and the Los Angeles County Bar Association.
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