With recommendations from the Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee, the Food and Drug Administration (FDA) announced a Public Health Advisory directing antidepressant manufacturers to expand their warning label on October 15, 2004.

While the FDA’s recommended “Black Box” warning label is extensive, most manufacturers of SSRI antidepressants have not used the FDA’s recommendations and only included one line statements on their websites. The FDA’s warning makes note of study results which indicate a 4% increased risk of suicide attempts in children and adolescents taking SSRIs antidepressants compared to a 2% risk of those taking a placebo.

SSRI drugs are second-generation antidepressants known as Selective Serotonin Reuptake Inhibitors and are a part of a large family of antidepressants that are used by millions of Americans on a daily basis. With significantly increased rates of children showing signs of depression and anxiety, more children are prescribed Paxil and other antidepressants to treat Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD) and Aspergers.

SSRIs:
Paxil (paroxetine)
Zoloft (sertraline)
Luvox (fluvoxamine)
Celexa (citalopram)
Effexor (venlafaxine)
Lexapro (escitalopram)

Paxil and many of the other SSRI antidepressants have not been formally approved by the FDA for use in children under 18 years of age, but it is not illegal to prescribe them. Physicians are allowed to prescribe these drugs on an “off-label” basis in which the physician or pharmacist accepts liability. In these cases, the medical and pharmaceutical communities are required to warn patients and their guardians of the side effects and risks of suicidal behavior. On the other hand, it is illegal for pharmaceutical companies to promote off-label use, such as promoting use of SSRI drugs for children under 18 years of age, through advertising or other communications. These actions are monitored by the Federal Trade Commission.

The widely prescribed antidepressant Prozac (fluoxetine) is also a SSRI drug, but it is not included in the group because its manufacturer, Eli Lilly, had previously undergone formal studies and won FDA approval for its use in children and adolescents.

With ongoing clinical studies being conducted and results examined, The American College of Neuropsychopharmacology (ACNP) joined the growing chorus of voices asking pharmaceutical companies to share all relevant data with FDA. The ACNP urged that all data held by FDA or pharmaceutical companies should be made rapidly available to allow the ACNP and other research organizations to conduct evaluations of the risks and benefits of SSRIs in youth and adults with depression and other mood disorders.

FDA has indicated that the manner in which pharmaceutical companies have responded to requests for data on pediatric suicides had been unsatisfactory. The FDA’s comments stop short of saying that the data had been “massaged” by the drug sponsors. Pharmaceutical companies are required to make periodic safety update reports to FDA including all serious adverse events, without FDA prompting.

SSRI use Outside the US

Paxil is banned for pediatric use in England and the UK Committee on Safety of Medicine (CSM) advises doctors that most SSRIs, such as the international equivalents to Zoloft, Celexa, Paxil, Lexapro, Effexor, Lexapro, are not suitable for children under the age of 18 years.

SSRI and Suicide In the News

A new analysis of over 87,000 patients taking SSRIs found an increased rate of suicide attempts compared to those taking a placebo or other therapies. (Feb-27-05) [NEWS-MEDICAL.NET]

FDA issues a Black Box warning label for antidepressants found to increase risk of suicidal thinking and behavior in children and adolescents. [FDA]