FDA Warnings For Antidepressant Medications

“Black Box” FDA Warnings for Antidepressant Medications

meds 9Despite perceived safety and popularity of SSRIs and other antidepressants, studies suggest usage can bring dangerous and understated side effects, especially for adolescents and young adults. In 2004, after a thorough review of data, the Food and Drug Administration (FDA) adopted a “black box” warning label on all antidepressant medications to alert the public for potential risks of increased suicidal thoughts in children and adolescents taking antidepressants.

In 2007, the agency extended the warning to include young adults up to age 25. A “black box” warning is the most serious type of warning on prescription drug labeling. The warning emphasizes that children, adolescents and young adults taking antidepressants should be closely monitored, especially during the initial weeks of treatment, for any worsening depression, suicidal thoughts, behaviors, or any unusual changes in behavior such as sleeplessness, agitation, or withdrawal from normal social situations. These FDA approved medications have never been tested on children or adolescents.

The FDA concludes these medications were not originally “designed” for adolescent use. Still, pharmaceutical companies were happy to give the impression these medications to be safe for children and young adults, especially for anxiety disorders, ADD, OCD, stress, social anxiety, sleep disorders, and many other conditionsdeadly med 3

Quite often prescription medications whose patents are about to expire, are reassigned or relabeled to address other illnesses or symptoms, which may be completely unrelated to the original disorders or symptoms they were tested and approved for. This means, more often than not, the relabeling of these powerful medications is a marketing ploy, to ensure highly profitable patents do not become lost revenue streams. That is good for the profits of pharmaceutical companies, but has little to do with health care or the well being of individuals.

In 2007 half a million children and teenagers were given at least one prescription for an antipsychotic medication. Over 20,000 of these children were under the age of 6. American children are on average are medicated with antidepressants and stimulants three times more than children elsewhere in the world. This epidemic is driven by ignorance, greed and profit, not because Americans are more mentally unfit.


Medications That May Contribute to Pediatric Suicide
For anyone, taking antidepressants can increase the likelihood of suicide. However, at this time the list of drugs receiving “black box” FDA warnings for pediatric suicide are:

  • Anafranil (clomipramine)
  • Asendin (amoxapine)
  • Aventyl (nortriptyline)
  • Celexa (citalopram hydrobromide)
  • Cymbalta (duloxetine)
  • Desyrel (trazodone HCl)
  • Effexor (venlafaxine HCl)
  • Elavil (amitriptyline)
  • Etrafon (perphenazine/amitriptyline)
  • fluvoxamine maleate
  • Lexapro (escitalopram hydrobromide)
  • Limbitrol (chlordiazepoxide/amitriptyline)
  • Ludiomil (maprotiline)
  • Marplan (isocarboxazid)
  • Nardil (phenelzine sulfate)
  • Norpramin (desipramine HCl)
  • Pamelor (nortriptyline)
  • Parnate (tranylcypromine sulfate)
  • Paxil (paroxetine HCl)
  • Pexeva (paroxetine mesylate)
  • Prozac (fluoxetine HCl)
  • Remeron (mirtazapine)
  • Sarafem (fluoxetine HCl)
  • Serzone (nefazodone HCl)
  • Sinequan (doxepin)
  • Surmontil (trimipramine)
  • Symbyax (olanzapine/fluoxetine)
  • Tofranil (imipramine)
  • Tofranil-PM (imipramine pamoate)
  • Triavil (perphenazine/amitriptyline)
  • Vivactil (protriptyline)
  • Wellbutrin (bupropion HCl)
  • Zoloft (sertraline HCl)
  • Zyban (bupropion HCl)
 Feel free to leave your comments or feedback below


  1. Interesting article. Surprised Big Pharma hasn’t posted some disclaimer.
    Black Box warnings unfortunately have little impact. Doctors prescribe medications and in our time of need, people take things blindly. While some read the small print, there is so much of it that it becomes overwhelming. The average precription medication comes with pages of warnings and instructions, all in extremely small print. Filled with enough technical terminology to confuse the average user. Some newer system of warning patients must be put in place if people are to really understand the potential dangers of what they are taking.
    But simplicity does not support the vested interests of drug manufactures. They want confusion, they want people to blindly follow their recommendations. So we watch their slick commercials with pretty people and soothing music for 60 second at a time and we feel safe. It is a great illusion from master manipulators

    • Amy Hall

      AMEN. And living with depression is living a tortured life with a potentially terminal illness and you would do anything for relief.

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