2008 Woodie Awards
Are They Really Cures?
Anti-depressants can be harmful to young children and teenagers.
Claudia Lozano
Issue date: 9/29/04 Section: News
- Page 1 of 1
The Psychopharmacologic Drugs Pediatric Advisory Committee recommended that the Food and Drug Administration implement a "black box" warning label on all antidepressants. The vote was 15-8.
The black box advisory, the sternest of medical labels, will warn the public of an increased risk for suicidal thoughts and behaviors in pediatric and adolescent patients who take antidepressants. Nearly 3 percent of children who used the drugs manifested suicidal thoughts or behavior, according to the FDA website.
The drugs involved in this labeling change are Prozac (fluoxetine), Zoloft (sertraline), Paxil (paroxetine), Lovox (fluvoxamine), Celexa (Citalopram), Lexapro (escitalopram), Wellbutrin (bupropion), Effexor (venlafaxine), Serzone (nefazodone) and Remeron (mirtazapine).
"I think that we now all believe that there is an increase in suicidal thinking and action that is consistent across all the drugs," Dr. Robert Temple, director of the FDA's office of medical policy, said in a New York Times article. "This looks like it's a true bill."
Parents should be alert of changes in their child's behavior, at the start of treatment or when doses change. Symptoms may include but are not limited to anxiety, irritability, insomnia, akathisia and panic attacks.
Only Prozac is specifically approved for treating children and adolescents suffering from depression, while Prozac, Zoloft and Luvox are approved for use in children with obsessive-compulsive disorder (OCD) as indicated by the FDA. The other drugs are not approved for children and or adolescent use.
The committee urged the FDA to include new selective serotonin reuptake inhibitors (SSRI), such as Prozac, Zoloft, and Paxil, and old Tricyclics, such as Adapin, Anafranil, and Elavil.
Trycyclics are just as effective as SSRIs but have more side effects. A major advantage in SSRIs is that they are not quite as dangerous if some one overdoses according to the Royal College of Psychiatrists online, www.rcpsych.ac.uk.
Although the committee urged the FDA to take immediate action it did not support a contraindication of the drugs for those people who could benefit from their use.
If you or your child is currently using these or other antidepressants be advised of the risks involved and consult your doctor if any signs of depression worsen. For more information and updates go to www.fda.gov.
The black box advisory, the sternest of medical labels, will warn the public of an increased risk for suicidal thoughts and behaviors in pediatric and adolescent patients who take antidepressants. Nearly 3 percent of children who used the drugs manifested suicidal thoughts or behavior, according to the FDA website.
The drugs involved in this labeling change are Prozac (fluoxetine), Zoloft (sertraline), Paxil (paroxetine), Lovox (fluvoxamine), Celexa (Citalopram), Lexapro (escitalopram), Wellbutrin (bupropion), Effexor (venlafaxine), Serzone (nefazodone) and Remeron (mirtazapine).
"I think that we now all believe that there is an increase in suicidal thinking and action that is consistent across all the drugs," Dr. Robert Temple, director of the FDA's office of medical policy, said in a New York Times article. "This looks like it's a true bill."
Parents should be alert of changes in their child's behavior, at the start of treatment or when doses change. Symptoms may include but are not limited to anxiety, irritability, insomnia, akathisia and panic attacks.
Only Prozac is specifically approved for treating children and adolescents suffering from depression, while Prozac, Zoloft and Luvox are approved for use in children with obsessive-compulsive disorder (OCD) as indicated by the FDA. The other drugs are not approved for children and or adolescent use.
The committee urged the FDA to include new selective serotonin reuptake inhibitors (SSRI), such as Prozac, Zoloft, and Paxil, and old Tricyclics, such as Adapin, Anafranil, and Elavil.
Trycyclics are just as effective as SSRIs but have more side effects. A major advantage in SSRIs is that they are not quite as dangerous if some one overdoses according to the Royal College of Psychiatrists online, www.rcpsych.ac.uk.
Although the committee urged the FDA to take immediate action it did not support a contraindication of the drugs for those people who could benefit from their use.
If you or your child is currently using these or other antidepressants be advised of the risks involved and consult your doctor if any signs of depression worsen. For more information and updates go to www.fda.gov.
