2008 Woodie Awards
Black Box Warning Implemented
The FDA enforces sternest of medical labels on antidepressants.
Claudia Lozano
Issue date: 10/27/04 Section: News
- Page 1 of 1
The Food and Drug Administration ordered "black box" warning labels on all antidepressants prescribed to youth. New labels alert parents of possible suicide risk for children and adolescents.
FDA Commissioner Dr. Lester Crawford said that the agency seeks to balance the risk of suicidal behavior against the known benefits of treating depression in children. The new labels will also encourage prescribers to balance risk with clinical need.
In a collaborative effort, the FDA's and manufacturers' "unit of sale" packaging will make sure every medication has all information necessary, including an accompanying user guide to describe warning signs of depression, irritability, and unusual changes in behavior. It urges supervising adults to contact a doctor immediately at the first sign of concern.
Suicidal thoughts and behaviors surfaced in more than 4,400 patients taking antidepressants, during the first few months of taking medication or after dosage changes in recent clinical trials by the Center of Drug Evaluation and Research.
Celexa, Zoloft and Prozac had fewer incidents than Paxil, Luvox and Effexor which posed higher risks of suicidal thoughts and behavior in children, according Healthyplace.com.
Newly labeled drugs include: Anafranil, Aventil, Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Marplan, Nardil, Norpramin, Paxil, Prozac, Remeron, Symbax, Trofanil, Zoloft and Zyban. Presently, only Prozac is FDA approved for treating depression in children and adolescents.
The FDA decision complies with federal advisers and health officials who blamed antidepressants for suicidal behaviors displayed by children.
For more information consult your doctor, local pharmacist or visit the FDA online at www.fda.gov.
FDA Commissioner Dr. Lester Crawford said that the agency seeks to balance the risk of suicidal behavior against the known benefits of treating depression in children. The new labels will also encourage prescribers to balance risk with clinical need.
In a collaborative effort, the FDA's and manufacturers' "unit of sale" packaging will make sure every medication has all information necessary, including an accompanying user guide to describe warning signs of depression, irritability, and unusual changes in behavior. It urges supervising adults to contact a doctor immediately at the first sign of concern.
Suicidal thoughts and behaviors surfaced in more than 4,400 patients taking antidepressants, during the first few months of taking medication or after dosage changes in recent clinical trials by the Center of Drug Evaluation and Research.
Celexa, Zoloft and Prozac had fewer incidents than Paxil, Luvox and Effexor which posed higher risks of suicidal thoughts and behavior in children, according Healthyplace.com.
Newly labeled drugs include: Anafranil, Aventil, Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Marplan, Nardil, Norpramin, Paxil, Prozac, Remeron, Symbax, Trofanil, Zoloft and Zyban. Presently, only Prozac is FDA approved for treating depression in children and adolescents.
The FDA decision complies with federal advisers and health officials who blamed antidepressants for suicidal behaviors displayed by children.
For more information consult your doctor, local pharmacist or visit the FDA online at www.fda.gov.
