Prozac, Paxil, Wellbutrin, Zoloft, Celexa, Effexor, Luvox and Remeron should have "Black Box" warnings

Sep 14 2004

A panel of experts has voted 15 to 8 in favour of the Federal Food and Drug Administration (FDA) adding black box warnings to certain medications used to treat depression in children and teenagers.

Black box warnings were created to alert and inform health professionals of potentially severe, life-threatening adverse events associated with a particular medication.

The panel recommended that antidepressant medications such as Prozac and Paxil need stronger warnings highlighting the risk of suicidal behaviour in children.

Two or three out of every 100 young people treated with antidepressants might be at higher risk of suicidal behaviour.

The panelists said the concern applied to all nine drugs studied:

• Eli Lilly and Co.'s Prozac,
• GlaxoSmithKline Plc's Paxil and Wellbutrin,
• Pfizer Inc.'s Zoloft.
• Forest Laboratories Inc.'s Celexa,
• Wyeth's Effexor,
• Solvay SA's Luvox and
• Akzo Nobel NV's Remeron were also reviewed.

Bristol-Myers Squibb's Serzone was also included, but the company discontinued the drug earlier this year.

This follows an FDA warning on the 6-Apr-2004 about the possibility of worsening depression or suicidal thought in people, particularly children, who take any of 10 popular antidepressants, especially at the beginning of treatment or when the dosage is changed.

This warning also recommended that other signs of worsening depression, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, severe restlessness, and mania (feeling extremely happy or very irritable, inflated self-esteem, not needing as much sleep as usual, talking or being more active than usual) should also be evaluated.

On the 20-Jul-2004 a study in The Journal of the American Medical Association reported that the risk of suicidal behavior was highest in the first month after starting antidepressants.

The rate at which antidepressant drugs are prescribed for the nation’s children and adolescents is now a major concern with recent research from Washington State University suggesting three fold increases between the early 1990s and 2001.