Reply #7: studies linking meds to violence-it is termed an ADVERSE reaction to meds [View All]

[fed-up]

http://medicine.plosjournals.org/perlserv/?request=get-...
Antidepressants and Violence: Problems at the Interface of Medicine and Law
David Healy*, Andrew Herxheimer, David B. Menkes

Funding: The authors received no specific funding for this article.

Introduction
In 1989, Joseph Wesbecker shot dead eight people and injured 12 others before killing himself at his place of work in Kentucky. Wesbecker had been taking the selective serotonin reuptake inhibitor (SSRI) antidepressant fluoxetine for four weeks before these homicides, and this led to a legal action against the makers of fluoxetine, Eli Lilly <1>. The case was tried and settled in 1994, and as part of the settlement a number of pharmaceutical company documents about drug-induced activation were released into the public domain. Subsequent legal cases, some of which are outlined below, have further raised the possibility of a link between antidepressant use and violence.

The issue of treatment-related activation has since then been considered primarily in terms of possible increases in the risk of suicide among a subgroup of patients who react adversely to treatment. This possibility has led regulatory authorities to warn doctors about the risk of suicide in the early stages of treatment, at times of changing dosage, and during the withdrawal phase of treatment. Some regulators, such as the Canadian regulators, have also referred to risks of treatment-induced activation leading to both self-harm and harm to others <2>. The United States labels for all antidepressants as of August 2004 note that “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 nonpsychiatric” <3>. Despite these developments, few data are available on the links between antidepressant usage and violence. We here offer new data, review the implications of these data, and summarise a series of medico-legal cases.

This paper focuses on paroxetine primarily because we have access to more illustrative medico-legal case material for this drug than for other antidepressants. Secondly, the manufacturer, GlaxoSmithKline, submitted data on the rates of occurrence of “hostile” episodes on paroxetine for the recent review of antidepressant drugs undertaken by the British regulator <4,5>. It is not clear that the review team obtained comparable data for other antidepressants.

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Discussion
Mechanisms of antidepressant-induced violence
A link between antidepressant use and violence needs a plausible clinical mechanism through which such effects might be realised. There are comparable data on increased rates of suicidal events on active treatment compared to placebo <16,17>. In the case of suicide, several explanations have been offered for the linkage. It is argued that alleviating the motor retardation of depression, the condition being treated, might enable suicides to happen, but this cannot explain the appearance of suicidality in healthy volunteers. Mechanisms linking antidepressant treatment, rather than the condition, to adverse behavioural outcomes include akathisia, emotional disinhibition, emotional blunting, and manic or psychotic reactions to treatment. There is good evidence that antidepressant treatment can induce problems such as these and a prima facie case that akathisia, emotional blunting, and manic or psychotic reactions might lead to violence.

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Substantial evidence from SSRI clinical trials shows that these drugs can trigger agitation. Approximately five percent of patients on SSRIs in randomised trials drop out for agitation against 0.5% on placebo. The current data sheets for SSRI antidepressants specify that the drugs can cause akathisia and agitation, and warn about developing suicidality in the early phase of treatment, on treatment discontinuation, and in the wake of a dosage increase during the course of treatment. In the US, these warnings explicitly apply to not only depressed patients but also people being treated for anxiety, smoking cessation, or premenstrual dysphoric disorder. In Canada, warnings specify an increased risk of violence in addition to suicide.

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Case 1
DS was a 60-year-old man with a history of five prior anxiety/depressive episodes. These did not involve suicidality, aggressive behaviour, or other serious disturbance. All prior episodes had resolved within several weeks. In 1990 DS had had an episode of depression, which his doctor treated with fluoxetine. He had a clear adverse reaction to fluoxetine involving agitation, restlessness and possible hallucinations, which worsened over a three-week period despite treatment with trazodone and propranolol that might have been expected to minimise the severity of such a reaction. After fluoxetine was discontinued DS responded rapidly to imipramine.

In 1998, a new family doctor, unaware of this adverse reaction to fluoxetine, prescribed paroxetine 20 mg to DS, for what was diagnosed as an anxiety disorder. Two days later having had, it is believed, two doses of medication, DS using a gun put three bullets each through the heads of his wife, his daughter who was visiting, and his nine-month-old granddaughter before killing himself.

At jury trial in Wyoming in June 2001, instigated by DS' surviving son-in-law, a jury found that paroxetine “can cause some people to become homicidal and/or suicidal” <39>. SmithKline Beecham was deemed 80 percent responsible for the ensuing events <1>. The documentary evidence included an unpublished company study of incidents of serious aggression in 80 patients, 25 of which involved homicide.

Experts for the plaintiff suggested that the mechanism through which paroxetine contributed to these events was probably akathisia or psychosis. A central problem with both akathisia and psychosis in such contexts is that the takers of medications often fail to recognise the fact that the state they are in is drug-induced and that discontinuing treatment can alleviate the symptoms.

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http://www.ssristories.com /

This website is a collection of 2100+ news stories with the full media article available, mainly criminal in nature, that have appeared in the media (newspapers, TV, scientific journals) or that were part of FDA testimony in either 1991, 2004 or 2006, in which antidepressants are mentioned.

Antidepressants have been recognized as potential inducers of mania and psychosis since their introduction in the 1950s. Klein and Fink1 described psychosis as an adverse effect of the older tricyclic antidepressant imipramine. Since the introduction of Prozac in December, 1987, there has been a massive increase in the number of people taking antidepressants. Preda and Bowers2 reported that over 200,000 people a year enter a hospital with antidepressant-associated mania and/or psychosis. The subsequent harm from this prescribing can be seen in these 2100+ stories.

These stories have been collected over a period of years by two directors of the International Coalition for Drug Awareness (ICFDA). Their focus has been on Selective Serotonin Reuptake Inhibitors (SSRIs), of which Prozac was the first. Other SSRIs are Zoloft, Paxil (Seroxat), Celexa, Sarafem (Prozac in a pink pill), Lexapro, and Luvox. Other newer antidepressants included in this list are Remeron, Anafranil and the SNRIs Effexor, Serzone and Cymbalta as well as the dopamine reuptake inhibitor antidepressant Wellbutrin (also marketed as Zyban).

A public health problem of epidemic proportions

The Physicians' Desk Reference lists the following adverse reactions (side effects) to antidepressants among a host of other physical and neuropsychiatric effects: manic reaction (mania, e.g. kleptomania, pyromania, dipsomania), emotional lability (or instability), abnormal thinking, alcohol abuse, hallucinations, hostility, lack of emotion, paranoid reaction, amnesia, confusion, agitation, delirum, delusions, hysteria, psychosis, sleep disorders, abnormal dreams, and discontinuation (withdrawal) syndrome. Adverse reactions are especially likely when starting or discontinuing the drug, increasing or lowering the dose or when switching from one SSRI to another SSRI. Adverse reactions are often diagnosed as bipolar disorder when the symptoms could be entirely iatrogenic (treatment induced). Withdrawal, especially abrupt withdrawal, from any of these medications can also cause severe neuropsychiatric and physical symptoms. It is important to withdraw extremely slowly from these drugs, usually over a period of a year or more, under the supervision of a qualified and experienced specialist.

In addition to the adverse reactions listed in the Physicians' Desk Reference, the FDA published a Public Health Advisory on March 22, 2004 which states (in part): "Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe 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 nonpsychiatric." (Click Links button at bottom of this page for a direct link to this FDA Warning.)

Most of the stories on this site describe events which occurred after the year 2000. The increase in online news material and the efficiency of search engines has greatly increased the ability to track stories. Even these 2100+ documented stories only represent the tip of an iceberg since most stories do not make it into the media. There are 45 cases of bizarre behavior, 28 school shootings/incidents, 49 road rage tragedies, 10 air rage incidents, 32 postpartum depression cases, over 500 murders (homicides), over 180 murder-suicides and other acts of violence including workplace violence on this site.