SSRIs

As our society progresses there comes social changes, different attitudes and new ways of thinking. New generations replace the old; unemployment figures ebb and flow, colleges and universities become more competitive as the population increases, high schoolers are faced with worry of the future and the world around them; sex, violence and drugs are invading their lives at earlier and earlier ages. The youth of today are faced with a plethora of emotional, social and physical challenges which has resulted in an epidemic of depression and anxiety.

In our desperate hours many turn to science for an answer. We trust pharmaceutical companies to develop safe alternatives for sickness and disease of both the body and the mind; when a drug is available on the market we assume its benefits will outweigh its risks. This, however, is not always the case. Antidepressant prescriptions in children and teenagers are on the rise and not necessarily the cure for you or your child.

What are SSRIs?

Selective Serotonin Reuptake Inhibitors (SSRIs) are the newest and most popular form of antidepressant drugs on the market. SSRIs have largely replaced the antidepressants of old (tricyclics and monoamine oxidase inhibitors) which interfered with neurotransmitters and receptor sites all over the brain and resulted in many undesirable side effects.

The physiological cause of depression lies in the nerve cells in the brain. The brain has messenger molecules, known as neurotransmitters, which relay information across gaps between brain cells. When the level of these neurotransmitters is low communication in the brain slows down and depression sets in. While there are over 100 different neurotransmitters in the brain there are 3 important ones related to depression: serotonin, norepinephrine and dopamine.

SSRIs, as their name implies, focus specifically on serotonin. The brain will release serotonin and then reabsorb it (know as reuptake) so it can be used at a later time. Physiological depression occurs when the brain doesn’t have enough serotonin to maintain a stable mood; interfering with the reuptake of this chemical back into the brain (which is the design and function of SSRIs) allows for more messages to be sent throughout the brain and results in a steadier, happier mood.

What are the most widely prescribed SSRIs?

Prozac® became available in 1988 and by 1990 was touted as the “new wonder drug for depression” by Newsweek and New Yorker magazines (1). Prozac remains the only antidepressant on the market approved for treating childhood depression. Shortly after Prozac’s initial success four more SSRIs appeared on the market: Paxil ®, Zoloft ®, and Luvox® in the mid-1990s, followed by Celexa® in 1998. In 2003, an estimated 124 million prescriptions were written for antidepressant medications (3).

SSRIs and Teen Suicide

A history of suicidal thinking

1990, an American Journal of Psychiatry article details six cases in which previously non-suicidal patients developed intense, violent, suicidal preoccupation after two to seven weeks on Prozac.

1991, an FDA advisory committee votes 6-3 against adding warnings to Prozac’s label. Family members claimed the drug was linked with suicidal behavior, but committee members said they didn’t have enough evidence. Prozac maker Eli Lilly and Co. said a reanalysis of its data didn’t show a link a between the drug and suicidal behavior.

1993, the American College of Neuropsychopharmacology convenes a task force to study the issue and concludes there is no scientific evidence indicating SSRIs can trigger suicidal behavior.

1997, Congress authorizes the FDA to request clinical trials of drugs on children in return for giving drug makers patent extensions. The agency later requests drug makers test eight antidepressants on children.

May 2003, the FDA receives results from GlaxoSmithKline’s Paxil tests on children that shows depressed children on the drug might be at higher risk for suicidal behavior than those on a placebo.

June 2003, the FDA asks makers of eight other antidepressants for information on suicidal thoughts and actions documented in pediatric clinical trials.

December 2003, Britisth drug regulators warn doctors against prescribing six new-generation drugs for depressed children – Paxil, Zoloft, Effexor®, Celexa, Lexapro® and Luvox – saying they haven’t been proven effective on depressed children and are therefore too risky to prescribe.

January 21, 2004, another American College of Neuropsychopharmacology task force releases a preliminary report concluding new-generation antidepressants, known as SSRIs, do not increase the risk of youth suicidal thought or behavior.

February 2004, an FDA advisory committee asks the FDA to strengthen warning labels on antidepressants after listening to dozens of people testify, including family members who blamed the drugs for the deaths of their children.

March 2004, the FDA tells doctors and families to carefully monitor patients on ten popular antidepressants for suicidal thoughts and asks manufacturers to add warnings to SSRI drug labels (3).

On September 14, 2004 the FDA voted 15-8 to recommend SSRI drug manufacturers add a black box warning label stating that these drugs can be linked to suicidal thoughts and behavior in children and adolescents. The black box warning is the most strongly worded and serious label available. All magazine and television ads are required to include the warning. The FDA panel, which reviewed both published and unpublished clinical data, concluded that 2-3 out of every 100 young people treated with antidepressants might be at increased risk of suicidal behavior.

The FDA stated, “Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2% (4).”

What signs should I watch for if my child is taking an antidepressant?

Contact your child’s healthcare provider immediately if your child exhibits any of the following signs for the first time, or if they seem worse, worry you, your child, or your child’s teacher:

  • Thoughts about suicide or dying
  • Attempts to commit suicide
  • New or worse depression
  • New or worse anxiety
  • Feeling very agitated or restless
  • Panic attacks
  • Difficulty sleeping (insomnia)
  • New or worse irritability
  • Acting aggressive, being angry, or violent
  • Acting on dangerous impulses
  • An extreme increase in activity and talking
  • Other unusual changes in behavior or mood

I am currently taking an antidepressant. What should I do?

You should consult your doctor to discuss the best course of action if you observe worsening depression, the emergence of suicidal thinking, or if you are experiencing other symptoms that you are concerned might be related to your medication. It is very important that you do not stop taking your antidepressant without first checking with your doctor. Some of these medications may be associated with discontinuation symptoms if stopped abruptly. If your doctor advises that your medication should be stopped, be sure to follow your doctor’s advice regarding how to safely accomplish this.

Sources:

Selective Serotonin Reuptake Inhibitors by Turkington and Kaplan, M.D., WebMD Medical Reference from “Making the Antidepressant Decision” accessed 5/2/2005

Medications for Treating Depression and Anxiety (www.helpguide.org)

“A History of Suicidal Thinking” from the Baltimore Sun’s FDA Debates Youth Suicide, Antidepressant Link by Julie Bell, 16 April 2004.

FDA antidepressant warning label change


Never discontinue taking any medication without first consulting with your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Celexa and Lexapro are registered trademarks of Forest Pharmaceuticals, Inc.; Effexor is a registered trademark of Wyeth Pharmaceuticals, Inc.; Luvox is a registered trademark of Solvay Pharmaceuticals, Inc.; Prozac is a registered trademark of Eli Lilly and Company; Paxil is a registered trademark of GlaxoSmithKline; Zoloft is a registered trademark of Pfizer Pharmaceuticals, Inc. and all are used here only to identify the products in question.

This law firm is not affiliated with, sponsored by or associated with Pfizer Inc., Forest Pharmaceuticals, Inc., Solvay Pharmaceuticals, Inc., Eli Lilly and Company, Wyeth Pharmaceuticals, Inc., GlaxoSmithKline, the Baltimore Sun, HelpGuide.org, WebMD or the FDA.

Cases may be referred to another attorney or law firm.