Posted By Jim Vititoe on October 14, 2004
Today the Food and Drug Administration (FDA) directed manufacturers of all antidepressant drugs to revise the labeling for their products to include a boxed warning and expanded warning statements that alert health care providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and to include additional information about the results of pediatric studies. FDA also informed these manufacturers that it has determined that a Patient Medication Guide (MedGuide), which will be given to patients receiving the drugs to advise them of the risk and precautions that can be taken, is appropriate for these drug products. These labeling changes are consistent with the recommendations made to the Agency at a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee on September 13-14, 2004.
The drugs that are the focus of this new labeling language are all drugs included in the general class of antidepressants; they are listed at the end of this Advisory.
The risk of suicidality for these drugs was identified in a combined analysis of short-term (up to 4 months) placebo-controlled trials of nine antidepressant drugs, including the selective serotonin reuptake inhibitors (SSRIs) and others, in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. A total of 24 trials involving over 4400 patients were included. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2%. No suicides occurred in these trials. Based on these data, FDA has determined that the following points are appropriate for inclusion in the boxed warning:
- Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders.
- Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with the clinical need.
- Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.
- Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.
- A statement regarding whether the particular drug is approved for any pediatric indication(s) and, if so, which one(s).
Among the antidepressants, only Prozac is approved for use in treating MDD in pediatric patients. Prozac, Zoloft, Luvox, and Anafranil are approved for OCD in pediatric patients. None of the drugs is approved for other psychiatric indications in children.
Pediatric patients being treated with antidepressants for any indication should be closely observed for clinical worsening, as well as agitation, irritability, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. This monitoring should include daily observation by families and caregivers and frequent contact with the physician. It is also recommended that prescriptions for antidepressants be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
In addition to the boxed warning and other information in professional labeling on antidepressants, MedGuides are being prepared for all of the antidepressants to provide information about the risk of suicidality in children and adolescents directly to patients and their families and caregivers. MedGuides are intended to be distributed by the pharmacist with each prescription or refill of a medication.
FDA plans to work closely with the manufacturers of all approved antidepressant products that are the subject of today”s letters to optimize the safe use of these drugs and implement the proposed labeling changes and other safety communications in a timely manner. The labeling changes at issue will be posted on FDA’s website http://www.fda.gov/cder/drug/antidepressants/default.htm.
If you have been seriously injured by the above event, please visit the products liability lawyers at Masry & Vititoe for a case evaluation. Through experience and education, Masry and Vititoe is able to expertly evaluate medical injuries and pursue personal injury claims on behalf of the injured plaintiff.
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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