antidepressants and teen suicide

1. Antidepressants and Teen Suicide By: Ann Kuharevicz PHY111 Fall 2004

3. Facts and Stats Since the early 1990�s, the number of children in the U.S. taking antidepressants has more than doubled. It is estimated that children and adolescents make up about 8% of patients prescribed antidepressant drugs in the U.S., constituting over ten million prescriptions dispensed in 2003 for patients younger than 18 years old. Antidepressant prescription drugs developed for adults are regularly prescribed to young people even though most have never been specifically approved for use by depressed children and adolescents.

4. Prozac is the only antidepressant approved by the FDA for use for treating depression in pediatric patients. The FDA denied manufacturers� applications for approval to prescribe Celexa, Effexor, Paxil, or Zoloft for patients under 18 years old because studies showed they were not effective. Anafranil, Prozac, Luvox and Zoloft are approved for treating obsessive compulsive disorder in pediatric patients. Facts and Stats

5. There is no correlation One side of the argument contends that there is no relationship between the use of antidepressants and the risk of suicidal thoughts and behavior in adolescents. The depression itself is the fundamental cause of suicide in teenagers. Prescribing antidepressants reduces the risk of suicidality, suicidal thoughts and behavior.

6. Antidepressants have reduced teen suicides In the last decade, a fall in adolescent suicide rates in the U.S. has coincided with an increase in the use of drugs to treat depression. Now, new study findings strengthen this association by showing that these changes often occurred in the same geographical regions. "Suicide rates tended to be high in regions with high antidepressant use," says lead author Dr. Mark Olfson, from Columbia University in New York. "However, when we looked at changes that occurred with time, a decrease in suicide rates in a particular region often paralleled an increase in antidepressant use." Overall, a 1% rise in antidepressant use by teens was accompanied by a drop of 0.23 suicides per 100,000 adolescents per year.

7. Antidepressants have reduced teen suicides A psychiatry professor at the University of Texas Southwest Medical Center in Dallas, Dr. Graham Emslie, who conducted early studies that found Prozac and Paxil effective in depressed teens and children is not impressed with the published statistics. "It's not convincing yet. There were no deaths in any of the clinical trials." Postmortem studies also found that the "majority of kids who killed themselves had no blood levels of medicine in them," the Dallas professor added. Moreover, Dr. Emslie said British authorities say the drugs have only a 2 � 3% efficacy in minors. In contrast, his study found that 60% of adolescents on antidepressants improved compared with a 40% improvement rate in those on placebos.

8. Antidepressants plustherapy aid teen depression Researchers say that combining antidepressants with psychotherapy (talk therapy) works best in treating depressed teens. A study involving one of four treatments for 12 weeks was performed on 439 depressed adolescents: 1) the combined treatment of Prozac plus a form of psychotherapy, 2) Prozac-only, 3) behavior therapy-only, and 4) placebos. Overall, 71% of patients on the combined treatment, 61% of Prozac-only patients, 43% of behavior therapy-only patients, and 35% of patients on placebos had scores showing substantial improvement on a depression rating scale.

9. Antidepressants plus therapy aid teen depression 24 out of 439 patients exhibited suicidal tendencies. Study co-author John Curry of Duke University said too few patients exhibited suicidality to determine whether there truly are differences among the treatments studied. "The first thing that needs to be clear is that the overall rates are low" and that combining Prozac with talk therapy seems to mitigate any suicidal risks, Dr. Curry said. The study makes "a very important contribution" by showing that there is effective treatment, said Dr. Thomas Insel, director of the National Institute of Mental Health, which funded the study. "I wouldn't in any way downplay the adverse events," Dr. Insel said. But "just because a few kids develop this doesn't mean that you don't treat anybody."

10. SSRIs are effective An American College of Neuropsychopharmacology task force concluded that SSRIs, selective serotonin reuptake inhibitors, do not increase teens' risk of suicidal thinking or suicide attempts and are effective in treating depression in this population. The task force determined that SSRIs are the only antidepressant drugs effective in treating depression in children and adolescents. If anything, the panel concluded, the increased use of SSRIs appears to have lowered the risk of suicide worldwide based on a review of epidemiological studies from several countries. The group noted that the rate of youth suicide in 15 countries had declined by about 33% over the past 15 years, a period of time that coincides with increases in SSRI prescribing rates.

11. SSRIs are effective Dr. Suzanne Vogel-Scibilia, a psychiatrist and mother of a teenager on antidepressants, credits the drug Wellbutrin and another drug for her son to handle mood swings and the anger that can accompany them. To Dr. Vogel-Scibilia, "the bottom line is that drugs to treat mental illness, not to mention research to improve the drugs, are important and that depression and other mental health problems are under-diagnosed." She fears the suicide controversy will simply scare more people away from getting care. "If you look at suicides, the majority of them are not in treatment," she said. "What's the cost of untreated mental illness?" Her 15 year-old son, Tony, pleaded before an advisory committee for the U.S. Food and Drug Administration, "Help me preserve my future -- don't take away my medication.''

12. It�s not the drugs "The most likely explanation for the episodes of attempted suicide while taking SSRIs is the underlying depression," said Dr. Graham Emslie. Suicide is the third leading cause of death among young people and depression and other psychiatric disorders are major causes of suicide.

13. There is a correlation Clinical studies revealed that various antidepressants do increase suicidal thinking and suicide attempts in pediatric patients with major depressive disorder (MDD). In October 2004, the FDA ordered new warning labels for antidepressants to explain the risk of suicidal behavior in youth. The information must also state whether the drug has been approved for use by children.

14. Violence and death In 1990, Harvard researcher Martin Teicher and two colleagues published a study in the American Journal of Psychiatry about six patients who developed "violent suicidal preoccupation" after taking Prozac for two to seven weeks. "It was remarkable how violent these thoughts were," the authors reported. "Two patients fantasized, for the first time, about killing themselves with a gun," they wrote, while one placed a loaded gun to her head. Another had to be restrained to prevent self-mutilation, and another fantasized about killing himself in a gas explosion. None of the patients was suicidal when they started taking Prozac, the researchers reported, and their obsession with violence and death ended when they stopped.

15. The UK speaks out In June 2003, researchers in the United Kingdom issued a warning urging doctors not to prescribe the antidepressant drug Paxil to children and teenagers based on results of clinical trials. A study of 1,100 children enrolled in clinical trials of Paxil showed those taking the drug were nearly three times as likely to consider or attempt suicide as children taking placebos. "There is an increase in the rate of self-harm and potentially suicidal behavior in this age group," said a statement from the British Medicines and Healthcare Products Regulatory Agency (MHRA). "It has become clear that the benefits (of Paxil) in children for the treatment of depressive illness do not outweigh these risks."

16. The U.S. listens Approximately one week later, the United States FDA warned that no one under age 18 should be prescribed the drug for major depression. It also announced that it would conduct a detailed review of pediatric trials of Paxil. This review soon broadened to include other antidepressants, including top sellers Prozac, Zoloft, and Effexor. In August, Wyeth Pharmaceuticals warned doctors that its drug, Effexor, triggered hostile behavior or suicidal thinking in children at twice the rate as the sugar pills taken as placebos.

17. The UK acts One month later, the MHRA announced that it was urging doctors to stop prescribing a group of six antidepressants, including Paxil, Zoloft, and Effexor because they caused an increase in suicidal thoughts and actions. "These products should not be prescribed as new therapy for patients under 18 years of age with depressive illness," wrote Gordon Duff, chairman of the MHRA's Committee on Safety of Medicines. Prozac, the only SSRI approved for use in depressed children, was not included in the new warning. The British review did not find a significant increase in the risk of suicide-related events among children taking the drug.

18. After 24 trials involving more than 4,400 patients taking antidepressants, researchers found a greater risk of increased suicidality during the first few months of treatment. In these clinical trials, of nine antidepressants, none of the more than 4,400 children or teens actually committed suicide, but 4% reported suicidality, compared with 2% of those who were given a placebo. Based on these findings, in October 2004, the FDA announced that all nine of these drugs must carry a �black box� warning, the strongest warning the United States can put on prescription drugs.

19. Drug companies & the FDA To understand how it got to this point, it is important to know how the drug approval process works. When a drug company applies to the FDA for approval to sell a medication, it must demonstrate that the drug is safe and effective for a particular population, such as adults, and a specific condition, such as depression. Once the drug has been cleared by the FDA and is on the market, doctors are free to prescribe it to anyone for any reason. "Off-label" prescribing, is quite common. The only real restriction is that drug companies cannot market drugs to unapproved groups. From 1987, when Prozac was first approved for adults, until early last year, when Prozac became the first SSRI approved for use in depressed children 7 and older, all antidepressants used by depressed children were prescribed off-label.

20. An uncontrolled experiment Critics say the widespread use of antidepressants by children amounts to an uncontrolled national experiment. The physicians prescribing the drugs are often pediatricians or family doctors with little or no training in psychopharmacology. The drugs are frequently given in the absence of therapy. The subjects of the experiment, the children, are too young to give meaningful consent. There is little understanding of the long- term effect these medications have on the structure of children's developing brains. And the evidence that the drugs are effective is less than impressive. Biological solutions to behavioral problems have become increasingly acceptable, even fashionable. It's simply become more acceptable to see behavior as a reflection of an imbalance in chemistry rather than an imbalance in life.

21. The side effects of SSRIs SSRIs have been proven to cause a medical condition called akathisia that is best described as severe agitation and a compelling need to be in constant motion as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. People with akathisia are unable to sit or keep still, complain of restlessness, fidget, rock from foot to foot, and pace. This can be an extremely distressing experience and can lead directly to mental confusion and suicidality. David Healy, an internationally known psychopharmacologist from the University of Wales College of Medicine, believes akathisia is the principal trigger for impulsive violence in some people taking SSRIs. "They became anxious, agitated, terrified, unable to sleep at night and restless."

22. Support works � drugs don�t Clinical trials, in both the U.S. and Britain, of Wellbutrin, Lexapro, Paxil, Zoloft, and Effexor found these drugs to be no more effective than placebos in treating depressed children. Perhaps the most notable finding from clinical trials of antidepressants is how many children respond well to placebos - as many as 59 percent in some studies. This high placebo response rate is a common finding in pediatric drug trials, in which children are generally seen once or twice a week by clinicians. �This suggests that simple support can help children in many cases," Healy says.

23. What do you think? There currently is no ban in the U.S. on prescribing antidepressants to minors. Should there be? If a ban were to be established, how do the children get the help they need? Would untreated depression, which itself is a risk factor for suicide, possibly raise the rate higher than if treated with antidepressants? Could antidepressants lower the suicide risk in some people while raising it in others?

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