For the first time in North American criminal history, a murder has been attributed to an anti-depressant drug. In the finding, handed down on the 16th of September 2011, a Canadian Judge said that he was satisfied that a 16 year old boy, who stabbed his brother’s friend in the stomach, would not have committed the offence had he not been treated with the drug Prozac (a brand of Fluoxetine).[1. Mike McIntyre, ‘Judge agrees Prozac made teen a killer’, Winnipeg Free Press, 17 September 2011. Available http://www.winnipegfreepress.com/breakingnews/judge-agrees-prozac-made-teen-a-killer-130010278.html (accessed 8 December 2011)]
The judge accepted the evidence of psychiatrist, Dr Peter Breggin who told the court that the boy’s symptoms were consistent with a Prozac Induced Mood Disorder with Manic Features. In delivering his decision the judge stated, “his basic normalcy now further confirms he no longer poses a risk of violence to anyone and that his mental deterioration and resulting violence would not have taken place without exposure to Prozac”.
As a result the judge ‘agreed to keep the case in youth court, where he faces a maximum sentence of four more years behind bars on the charge of second-degree murder. The Crown wanted his case raised to adult court, where he would have received a mandatory life sentence with no chance of parole for at least seven years.’
The boy, who had no history of violence, had been taking Prozac for 3 months. Over this period, his parents observed a marked deterioration in his behaviour and mood which included acts of violence and self-harm where previously no such signs existed. His alarmed parents returned to his doctor for advice. Instead of taking him off Prozac or reducing his dosage, his doctor increased the dose, obviously believing more of what appeared to be causing these dangerous behaviours, would solve the problem.
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) and is approved for use in Australia for the treatment of depression, obsessive compulsive disorder and premenstrual dysphoric disorder. However, it is routinely prescribed ‘off label’ for a range of other conditions including panic and eating disorders. SSRI’s are amongst the most widely prescribed drugs with tens of millions of patients on Fluoxetine worldwide.[2. Sushi Das, ‘Has Prozac made us Happy?’, The Age, 19 May 2007. Available (http://www.theage.com.au/news/in-depth/has-prozac-made-us-happy/2007/05/18/1178995400945.html (accessed 8 December 2011)] Australian Government Department of Health and Ageing figures revealed that in the 2008 financial year 110,848 Australians received Fluoxetine scripts that were subsidised via the Pharmaceutical Benefits Scheme.[3. Statistics provided by the Department of Health and Ageing, Pharmaceutical Benefits Division.]
Concerns about possible aggression and manic side effects of Prozac were first raised in Australia in the New South Wales parliament in 1995, just five years after the release of the drug in Australia.[4. Hon. D.J. Gay, Hansard, New South Wales Legislative Council, 23 November 1995. Available http://www.parliament.nsw.gov.au/prod/parlment/hansart.nsf/V3Key/LC19951123005 (accessed 8 December 2011)] Since 2007, the US Food and Drug Administration has labelled SSRI anti-depressants including Prozac with the highest possible ‘black box’ warning stating:
“All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric.”[5. Food and Drug Administration, Revisions to Product Labelling: Suicidality and Antidepressant Drugs, 5 July 2007. Available http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM173233.pdf (accessed 8 December 2011)]
The US Black Box warning was followed by similar warnings in Australia. The evidence that led to these warnings came from, ‘pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others)’ which ‘showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents [by 100%], and young adults ages 18-24 [by 50%] with major depressive disorder (MDD) and other psychiatric disorders.’[6. Food and Drug Administration, Revisions to Product Labelling: Suicidality and Antidepressant Drugs, 5 July 2007. Available http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM173233.pdf (accessed 8 December 2011)] The fact that SSRI antidepressants like Prozac are supposed to manage severe depression in young people but increase the risk of suicidality poses obvious questions.
Over a 10 year period, up until 30 June 2011, over 40 adverse events of self-harm and violence, including suicides, homicides and suicidal or homicidal ideation, for Fluoxetine were reported to the Australian Therapeutic Drugs Administration (examples are listed below). Hundreds of reports were recorded by the TGA for other antidepressants however, it is impossible to know the true number of actual events, as the voluntary nature of the reporting system means only a fraction of actual incidents gets reported.[7. A 2008 study by Curtin University pharmacologist Con Berbatis identified that, because reporting is voluntary, only a tiny fraction, (for GP’s only 2 per cent), of adverse events are reported. Con Berbatis, ‘Primary care and Pharmacy: 4. Large contributions to national adverse reaction reporting by pharmacists in Australia’, i2P E-Magazine, Issue 72, June 2008.]
Despite the fact that the manufacturers advise that Prozac and other SSRI antidepressants are ‘not recommended for use in children and adolescents under 18 years of age’ they are frequently prescribed ‘off label’ to even very young children.[8. Eli Lilly Australia Pty Limited, Consumer Medicine Information, PROZAC fluoxetine hydrochloride, revised June 2010. Available http://secure.healthlinks.net.au/content/lilly/cmi.cfm?product=lycprozc10610 (accessed 1 December 2011) ] Data provided by the Commonwealth Department of Health revealed that in the 2007-8 financial year 3,752 Australian children fifteen years old or younger (863 ten or younger, 117 six or younger) were prescribed Pharmaceutical Benefits Scheme funded Fluoxetine.[9. Statistics provided by the Department of Health and Ageing, Pharmaceutical Benefits Division. ]
Furthermore all the expense and risks of adverse side effects may be for little or no benefit. The efficacy of antidepressants are being questioned with some high profile, mainstream critics, arguing that placebos are just as effective and much safer in treating moderate depression. One such critic, Marcia Angell, MD, Senior Lecturer on Social Medicine at Harvard Medical School and former Editor-in-Chief of The New England Journal of Medicine, contends; ‘that clinical trials have failed to find antidepressants effective at all in mild to moderate depression; that many psychiatric drugs have devastating adverse effects, especially in children and when used long-term; and that despite the risks and uncertain benefits, use of psychiatric drugs is soaring and the heavy reliance on drugs diverts resources better spent on improving treatment’.[10. Arline Kaplan, ‘Antidepressants: Lifesavers – or Active Placebos’, Psychiatric Times, 5 October 2011. Available) http://www.psychiatrictimes.com/display/article/10168/1963701 (accessed 9 December 2011)]
In summary, taxpayers are subsidising the ‘off label’ use by children and adolescents of antidepressants, with questionable efficacy, that double their risk of suicidality. This invites some obvious questions: Is this the best way to spend our taxes? And more importantly, is this the best way to help troubled young people?
A sample from the Adverse Drug Reactions Committee (ADRAC) adverse event reports for Fluoxetine Hydrochloride
- A 54 year old woman attempted suicide. She was also suffering from mania and a confusional state.
- A 36 year old woman “attempted suicide”.
- A 36 year old woman was admitted to intensive care in a coma following a suicide attempt.
- A 51 year old woman “had sudden urge to murder someone”.
- A 37 year old woman was admitted to a psychiatric hospital suffering from “suicidal ideation, nausea, trembling, feelings of despair, anxiety, paranoia and fear”.
- A 16 year old boy suffering from agitation and auditory hallucinations heard voices “telling him to kill his mother, father, sister and himself”.
- A 45 year old man “became obsessively suicidal and cut his throat” 3/7 days after Prozac was stopped.
- A 17 year old girl “became manic half an hour after commencing antidepressant.”
- A 40 year old patient “experienced trembling, cramps, heard voices and had suicidal ideation.”
- A patient of unrecorded gender and age experienced “homicidal and suicidal ideation.”
- A patient of unrecorded gender and age attempted suicide after experiencing suicidal ideation.
- A 44 year old patient “experienced akathisia, suicidal ideation and suicide attempt.”
- A patient of unrecorded gender and age experienced “suicidal violence” and “aggression.”
- A patient of unrecorded gender and age experienced “suicidal ideation.”
- A patient of unrecorded gender and age experienced “suicidal ideation and “suicide attempt.”
- A 50 year old patient experienced “suicidal ideation, suicide attempt and akathisia.”
- A 37 year old patient attempted suicide.
- A patient of unrecorded gender and age experienced “suicidal ideation and suicide attempt.”
- A patient of unrecorded gender and age made a suicide attempt and was violent.
- A 16 year old girl “attempted to hang herself with television cord from curtain rail in hospital bedroom. Nurse said she found her at the last moment.”
- A 16year old girl “ingested 40 Panadol tablets. Also frequent self-harming.”
- A 16 year old girl “attempted suicide by ingestion of 80 Panadol, 20 Panadeine, 7 Olanzapine.”
- A 29 year old patient “developed acute suicidal akathisia” and made a suicide attempt.
- A 73 year old patient “experienced homicidal ideation and made a suicide attempt.”
- A 60 year old woman “experienced suicidal ideation, suicide attempt and homicidal ideation – she attempted to kill her parents.”
- A 69 year old patient “experienced suicidal ideation and was very anxious.”
- A 16 year old girl attempted to “strangle herself with and IPod cord in the bathroom of the hospital. Agitation. She ran around crying and banging her fists of the walls and windows begging to be let out. … it lasted about 10 minutes before I could settle her.”
- A patient of unrecorded gender and age “took a fistful of sleeping pills.”
- A 35 year old patient “murdered his wife whilst on Prozac. He had also experienced suicidal thoughts.”
- A female patient of unrecorded age “became seriously depressed, complained of headaches, and clenching jaw, was unable to sleep and started to self-harm. She began to have suicidal thoughts, was hyperventilating, agoraphobic, had five suicide attempts, was confused, tearful, phobic, aggressive, experienced akathisia and suspected serotonin syndrome. She experienced weird dreams, was impulsive, light headed, had numbness and tingling limbs and committed suicide by hanging on 11 September 2000 on the second attempt.”
- A 50 year old woman “became more depressed whilst taking Prozac. She wanted to throw herself off a train or bus, had difficulty sleeping, was pacing and restless, had voice hallucinations, would look in the mirror and see a different person, had murderous thoughts, stiff legs, was hot a lot, felt she was in a delirium, could not concentrate, was angry, had numbness in her hands and pins and needles a lot in her body.”
- A 19 year old male “had thoughts about killing himself which made him violent, tried to hit someone else, tried to hit a security guard with feelings of killing and tried to do physical damage. Tried to hurt himself and had thoughts of hurting other people. He was walking faster than normal. Experienced aggression, insomnia and was feeling high on Prozac. Also felt anxious and put on more than 20kg.”
- A male of unreported age “experienced severe depression, cognitive impairment and was acutely suicidal.”
- A 16 year old girl was “cutting herself, throwing herself against the walls while an inpatient”. She “intentionally overdosed on Fluroxetine” and “developed severe levels of aggression and violence.”
- A 14 year old boy experienced “suicidal ideation.”
- A female of unreported age “experienced suicidal ideation”.
- A 16 year old girl experienced “excessive bleeding, psychosis, high blood pressure, severe diarrhea, sweating, tremors, violent, aggressive and suicidal behavior, serotonin syndrome.”
- 14 year old male experienced “severely increased suicidal ideation in two days with high level of intent and plan to jump in front of train. Previously no suicidal ideation and settled spontaneously within four days of ceasing Fluoxetine”.
- A female patient experienced a “sudden and marked increase in hostility and verbal abuse of others and describes intrusive suicidal ideation. Seems agitated and restless”.
- A 32 year old woman experienced “audio hallucinations, bright and blurred vision, made everything sound louder, constipation, increased suicidal thoughts and increased anxiety”. [11. Australian Government, Department of Health and Ageing, Therapeutic Goods Administration, Public Case Detail, Fluoxetine Hydrochloride. Statistics provided by the Adverse Drug Reactions Committee (ADRAC).]