Brian at AntiDepAware wrote a very interesting blog this week. If ever there was a clear cut case of prescription drug induced suicide-homicide, this surely is it?
I read this week (on Twitter) that Brian’s blog ‘just gets better and better‘ and I absolutely agree with that statement. In my opinion it should be printed as a compulsory addendum to psychiatry’s DSM 5 – before the idiots reach for the prescription pad. His blog is copied verbatim below…
Vehicle fitter Nigel Maude (58) and his 57-year-old wife Judith (left) were described by their next-door neighbour, who had known them for 25 years, as “perfect neighbours.” He said: “They always seemed to do everything together including gardening and tidying up outside. I have never heard them argue. They were a lovely couple and totally devoted grandparents.”
Their deaths, therefore, were a “complete shock” to their family and everyone who knew them. Yesterday’s inquest revealed that, on August 11th this year, Mr Maude violently stabbed Judith to the back and neck with a kitchen knife and attempted to strangle and suffocate her at their home in the village of Hoghton, Lancashire. He then drove a short distance to a nearby railway line, where he stepped in front of a train.
The investigating police officer said that: “Mr and Mrs Maude were certainly of good character, had no real issues with debts and there were no reported crimes involving them.”
Deputy Coroner Simon Jones asked the officer: “There is nothing to suggest that this is anything but a happy and caring marriage?”
He replied: “No, nothing to suggest otherwise. This has come as a complete shock to everyone.”
It emerged, however, that Mr Maude had seen his GP 16 days before the deaths, complaining of insomnia and stress over financial worries about his mother, who was going to have to be placed in care. In a statement, GP Dr Stephen Howell said Mr Maude was a regular patient who suffered chronic arthritis but had no history of mental illness or depression.
Nevertheless, Dr Howell said he “prescribed Mr Maude prescription drugs.” Presumably, this accounted for the “low traces of a drug used to treat depression”, found by the pathologist in Mr Maude’s blood.
Recording verdicts of unlawful killing and suicide, the coroner said that the reason for Mr Maude’s actions could not be established for certain but that: “It may be stress in relation to issues relating to his mother going into a home. We don’t know.”
On the other hand, Coroner Jones, the reason for Mr Maude’s actions, in all probability, was that he had been mis-prescribed medication with known links to homicide and suicide, which NICE recommends only for moderate to severe depression.
RTE’s Prime-time (Irish National Broadcaster) tackled the issue of Lariam-induced suicides within the Irish army on May 23rd. The programme can be viewed here.
For those who are not aware of Lariam (aka Mefloquine), it is a highly controversial anti-malaria drug used within the defense forces when deployed overseas. The drug can cause many serious adverse effects and numerous families have blamed it for their loved one’s suicide. Interestingly, it comes 5th in the PLOS ONE‘Prescription Drugs associated with violence’ study (after Champix and Seroxat). The US army stopped the use of Lariam following numerous suicides and severe psychiatric reactions associated with its use. Tragically, for all concerned, this drug has been implicated in the massacre of 17 Afghan citizens including children by Sgt. Robert Bales (pictured) on March 11, 2012. His wife said “I have no idea what happened, but he would not – he loves children. He would not do that.“
A few weeks after the Prime-time programme (which included grieving families and their harrowing testimonies), I was disappointed to see the Minister for Defence, Alan Shatter, defending Lariam in the media. He defended the use of the drug, disputing its links to suicide and said “There is no evidence in any of the coroners’ inquests linking any deaths to Lariam.” He seemed to have completely undermined the Prime-time programme and it made no sense to me. Why would he do that?
Sorry but I have no answers to Minister Shatter’s involvement but I do have a very recent warning (8th July 2013) from Roche Pharmaceuticals which the Minister might find embarrassing. The link can be found here but Minister Shatter might find the excerpt below interesting.
Minister Shatter said of the nine cases of lariam suicides” “given the limited period of time during which Lariam remains in the bloodstream, according to our expert advice, it is extremely unlikely that the product could have been a contributory factor in practically all of these cases”. Irish Times June 19th. The following excerpt may help him a little bit with that one:
Roche, who originally marketed Lariam, is no stranger to controversy, having also invented the notorious acne drug Accutane. This drug is also widely linked to suicide and following numerous lawsuits in 2009 Roche pulled the drug from the US market. The Irish Medicine’s Board still allow it though despite a high profile court case involving a courageous Irish father here. Roche’s corruption and intimidation tactics were subsequently captured in Doug Bremner’s ‘Before You Take That Pill’.
What I do find interesting is why Roche came out with the warning now. Was it pressure from the Prime-time documentary? Was it pressure from the pharma-funded Irish Medicine’s Board? I doubt it! But one thing is for sure, it was not out of the goodness of Roche’s pharma heart.
So…exactly how long does it take for an antidepressant to kick in? A year and a half maybe?
In December 2010 a 55 year old south Wales woman Heidimarie Danskin, hung herself in her own home. She had been prescribed Citalopram 40 mgs for the previous year and a half. Sorry for stating the obvious but Citalopram didn’t work very well did it? Link.
What about Amanda Rothan, a 34 year old mother of four who died after taking an overdose of prescription drugs. She had been prescribed Citalopram in the previous few months before her death. Link.
In 2008, South Cumbria coroner Ian Smith speaking at an inquest of Nigel Woodburn, who died after driving into a tree, 4 days after being prescribed Citalopram said …“I have to say this is probably the fifth, if not sixth inquest I’ve heard within a period of three years when somebody either just going on to Citalopram or Seroxat, or coming off it, have killed themselves one way or another, totally out of the blue, totally without expectation, without a history of suicidal thoughts in the past.”
Mr Smith said “I think what happened to Mr Woodburn was in part as a result of the drugs he was taking. There has been publicity about these drugs recently, particularly relating to younger adults, and it does seem to me it’s something that needs to be highlighted.”
I know how boring and hard work it is for Shane’s friends to read about all this, so i,ll throw in a strange but true story. Lucy(3) was very upset last week when she was jumping up and down on her bed. I asked her what was wrong. She was so upset because she had forgotten how to fly.
She said she was flying with Shane and he brought her up to see heaven! She still firmly believes she was flying and has just forgotten how! She’s waiting for granny to show her how again.
identifies 31 drugs linked to 1,527 acts of violence…After two decades of contentious denials about the suicidal risk posed by certain psychoactive prescription drugs, numerous drugs now carry label warnings about suicidal behavior.
Now, a new study in PLoS One , identifies 31 drugs in FDA’s MedWatch adverse drug reports that are disproportionately linked to 1,527 acts of violence–defined as “Homicide,” “Physical assault,” “Physical abuse,” “Homicidal ideation” or “Violence-related symptom.”
The violence events in these widely prescribed drugs–for diverse patient populations–were reported to the FDA between 2004 and Sept. 2009.
The authors, Thomas J. Moore, Joseph Glenmullen, MD Curt D. Furberg, MD, identified 1,937 reports of violence submitted to FDA’s MedWatch that met a restrictive criteria:
The violence cases included 387 reports of homicide, 404 physical assaults, 27 cases indicating physical abuse, 896 homicidal ideation reports, and 223 cases described as violence-related symptoms. The patients were 41% female and 59% male with a mean age of 36 years (SD=17.9)Of all currently marketed prescription drugs, those linked to most of the violent events reported to the FDA are drugs that increase dopamine and /or serotonin in the brain–irrespective of the patient population.
The worst offender with the strongest association to uncontrollable, murderous violence–within days of ingesting the drug–is the smoking cessation drug, Chantix (varenicline), which increases dopamine: it ranks 18.0 in the proportional reporting ratio (PRR) with 408 cases of violence–including murder. There are two other smoking cessation drugs that do NOT pose serious risks of violence.
The next drugs most often linked to unprovoked violent outbursts–some resulting in murder–are 11 of 13 SSRI antidepressants. These not so, “magic bullets,” whose mode of action (reuptake inhibition) increases serotonin, were involved in 578 cases of violence.
Two drugs within the SSRI class–Prozac and Paxil--have been linked to the greatest number of reported cases of violence toward others: Prozac ranks 10.9 in the PRR, with 72 reported cases of violence, and Paxil (Paroxetine) ranks 10.2 in PRR, with 177 reported cases of violence.
The authors note that there was no signal for violence linked to mood stabilizers such as valproic acid, carbamazepine, and phenytoin, even though these drugs are commonly used in bipolar patients who may experience psychosis in the acute manic phase and therefore be more prone to violence. On the other hand, SSRI’s, which are clearly linked to violent actions in patients with no history of violent behavior, are being prescribed for patients with bipolar disorder. That is a prescription for disaster.
The other class of drugs that are demonstrably linked to violence are 3 drugs prescribed for ADHD–amphetamines, atomoxetine and methylphenidate–and 5 hypnotic /sedatives.
Only 0.25% of all serious adverse drug events met the PLoS study’s restrictive criteria of violence. Thus, it is likely that the number of cases included in the analysis is understated.
Not only does the FDA disregard the precautionary principle of medicine–“First, do no harm”– the agency is unleashing drugs whose mode of action–accelerating dopamine and or serotonin in the brain–poses serious threats of violence to bystanders in the community! Think of the school shootings….the postal shootings…the troop “friendly fire” deaths…
Read the complete article at PLoS One , “an interactive, open-access journal for the communication of all peer-reviewed scientific and medical research,”
Prescription Drugs Associated with Reports of Violence Towards Others
Thomas J. Moore1*, Joseph Glenmullen2, Curt D. Furberg3
1 Institute for Safe Medication Practices, Alexandria, Virginia, United States of America, 2 Department of Psychiatry-Cambridge Hospital, Harvard Medical School, Cambridge, Massachusetts, United States of America, 3 Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States of America
Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others.
To identify the primary suspects in adverse drug event reports describing thoughts or acts of violence towards others, and assess the strength of the association.
From the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) data, we extracted all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. We identified any case report indicating homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms.
Main Outcome Measures
Disproportionality in reporting was defined as a) 5 or more violence case reports, b) at least twice the number of reports expected given the volume of overall reports for that drug, c) a χ2 statistic indicating the violence cases were unlikely to have occurred by chance (p<0.01).
We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs.
Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional common features.
Citation: Moore TJ, Glenmullen J, Furberg CD (2010) Prescription Drugs Associated with Reports of Violence Towards Others. PLoS ONE 5(12): e15337. doi:10.1371/journal.pone.0015337
Editor: Joseph S. Ross, Yale University School of Medicine, United States of America
Received: October 9, 2010; Accepted: November 7, 2010; Published: December 15, 2010
Funding: The authors have no support or funding to report.
Competing interests: Mr. Moore has received consulting fees from litigators in cases involving paroxetine, and was an expert witness in a criminal case involving varenicline. Dr. Glenmullen has been retained as an expert witness in cases involving varenicline and psychiatric drugs including antidepressants, antipsychotics, benzodiazepines, mood stablizers, and ADHD drugs. Dr. Furberg has received consulting fees from litigators in cases involving gabapentin. This does not alter the authors’ adherence to the PLoS ONE policies on sharing data and materials.
Violent thoughts and acts towards others area common occurrence in our society but rarely studied as an adverse drug event. Increased risk of suicidal behaviors—but not violence— associated with antidepressants has been examined through meta-analysis of clinical trials for approval by the U.S. Food and Drug Administration. , 
Despite limited clinical study, numerous drugs contain FDA-required warnings to doctors or patients about the possibility of aggressive or violent acts. Among the drugs with warnings about aggressive behaviors are varenicline, zolpidem, montelukast, and all antidepressant drugs. – The mandatory patient Medication Guide for varenicline, the antidepressants and quetiapine warn patients to contact a healthcare provider immediately if they start “acting aggressive, being angry or violent.” , –
In this study we summarize and evaluate the evidence about reported acts of violence associated with therapeutic drugs among all serious adverse drug events reported to the FDA from 2004 through the third quarter of 2009.
The cases for this study were selected from the Institute for Safe Medication Practices (ISMP) QuarterWatch database of all adverse drug events reported to the FDA since 1968.  The FDA publishes for research use computer extracts of all adverse drug event reports that it receives,  and all such cases are included in the QuarterWatch database. While best known to medical professionals as “MedWatch Reports,” the FDA’s adverse event database also includes serious foreign cases from international drug companies who market the drugs in the United States. We limited this study to cases with serious outcome as defined by the FDA, and which includes death, disability, hospitalization, a life threatening event, an event that required medical intervention to prevent harm, or other medically serious conditions. The latest version of all cases with an initial report date from 2004 through the third quarter of 2009 was included. To qualify for inclusion in this study as an evaluable drug, it had to have wide enough clinical use and sufficient post marketing surveillance to have generated 200 or more case reports for any serious adverse event in the study period. Drug names were standardized from the QuarterWatch dictionary, which is in turn based on standardized ingredient names in the National Library of Medicine RxNorm database. 
Identification of Violence Reports
In the published computer extracts, the adverse event narrative description is replaced by one or more standardized medical terms selected from Version 11.1 of the Medical Dictionary for Regulatory Affairs (MedDRA).  We defined a violence event as any case report containing one or more of the following MedDRA terms: Homicide, Physical assault, Physical abuse, Homicidal ideation or Violence-related symptom. If a case report contained more than one of these terms, it was assigned to the most severe event term in the order listed above. In selecting terms from the MedDRA dictionary, we sacrificed some degree of sensitivity in case identification to achieve greater specificity. Thus, from the High Level Term group “Criminal Activity” we selected Homicide and Physical assault but omitted more ambiguous descriptors such as “Crime” or “Spousal Abuse.” Similarly from the High Level Term group Behavioral and Social Disturbances we selected Violence-related Symptom and Homicidal ideation but omitted the more general terms Aggression, Belligerence and Hostility. To assure an accurate count of widely used drugs for which no violence cases were reported we included all evaluable drugs in our data set.
Proportional Reporting Ratio
The null hypothesis for this study assumed that a violence case could be attributed to a drug by pure chance, and that drugs with a greater total number of adverse event reports might be exposed to greater risk of accruing a violence case. A drug might have a larger total number of adverse events reported for several reasons unrelated to safety, including more widespread clinical use, a higher reporting rate, the patient population treated, and more extensive international sales by the pharmaceutical sponsor.
To assess the null hypothesis we calculated the proportional reporting ratio (PRR) for each evaluable drug using the method of Evans.  With this method we compare the proportion of violence cases for each drug (drug violence events/all drug events) to the proportion of all other violence events for all other evaluable drugs (all other violence events/all other drugs events). For example, violence cases accounted for 35/3689 (0.95%) of all cases for the drug bupropion. For all the other drugs, violence cases accounted for 1902/776480 (0.2%) PRR = 3.9. In other words, the number of violence cases was 3.9 times greater for bupropion than for all other drugs combined after adjusting for the volume of reports. Using the χ2 test for independence, we assessed the strength of the relationship, and the probability that that the PRR could have occurred by chance. In the bupropion example, χ2 = 70.6 df = 1 p<0.01. To allow for the fact that some drugs might have as few as 5 index cases we applied the Yates correction to the χ2 statistic.
To be identified as disproportionally associated with violence cases, an evaluable drug had to have a PRR≥2, a χ2≥4.0, and 5 or more violence cases attributed. These are the Evans criteria except that our minimum threshold was 5 cases rather than the 3 cases specified in Evans. As a practical matter a χ2≥4 with 1 degree of freedom produces a sample estimate with p<0.01 but p values are provided to assess borderline cases.
The data for this study were maintained in an open source MySQL database (Oracle, www.mysql.com) and analyzed with open source software from the R-Project for Statistical Computing (www.r-project.org), version 2-11-0.
In the 69-month reporting period we identified 484 evaluable drugs that accounted for 780,169 serious adverse event reports of all kinds. This total included 1,937 (0.25%) cases meeting the violence criteria. The violence cases included 387 reports of homicide, 404 physical assaults, 27 cases indicating physical abuse, 896 homicidal ideation reports, and 223 cases described as violence-related symptoms. The patients were 41% female and 59% male with a mean age of 36 years (SD = 17.9) Consumers reported 651/1937 (38%) of the cases, foreign and domestic health professionals were the source for 967/1937 (49.9%) and the remainder were missing (217), from lawyers (67) or clinical studies (34).
Among 484 evaluable drugs, 31 drugs met the study criteria for a disproportionate association with violence, and accounted for 1527/1937 (79%) of the violence cases. The drugs are listed in Table 1. They include varenicline (a smoking cessation aid), 11 antidepressant drugs, 3 drugs for attention deficit hyperactivity disorder, and 5 hypnotic/sedatives. No violence cases were reported for 324/484 (66.9%) of all evaluable drugs, and 1 or 2 cases were reported for an additional 86/484 (17.8%). Thus, for 84.7% of all evaluable drugs in widespread clinical use, an association with violence appeared highly unlikely.
Table 1. Drugs associated with violence adverse drug events. doi:10.1371/journal.pone.0015337.t001
Table 2 shows the results for three drugs available as an aid to smoking cessation programs: varenicline, bupropion and nicotine replacement products. Bupropion is indicated for both depression and as an aid to smoking cessation, so those results are not limited to the smoking cessation population. Varenicline has the largest number of reported violence cases, the highest proportion of violence cases (PRR = 18.0) and the highest χ2 statistic (χ2 = 5172 df = 1 p<0.01) of any of the 484 evaluable drugs. Comparing reports of violence in the patient population seeking to discontinue smoking provides adjustment for the possibility that the side effects might be caused by stopping smoking rather than the drug.
Table 2. Drugs prescribed for smoking cessation. doi:10.1371/journal.pone.0015337.t002
Since psychoactive drugs accounted for most of the drugs identified we further analyzed them by class, including other drugs in the class that did not meet the criteria for an association. The results by drug class are shown in Table 3. These data indicate marked differences between drug classes. All the antidepressants were associated with violence cases, except for two tricyclics, trazodone and amitriptyline, which had a similarly elevated PRR that was statistically significant, but fewer than 5 required cases to qualify as suspect under our criteria. The PRR for all antidepressants combined was 8.4, higher than for any other class of psychoactive drugs. At the other extreme, mood stabilizers/anticonvulsants were not implicated with the exception of levetiracetam and overall the group did not indicate an elevated risk. Results for the antipsychotics were mixed, ranging from a PRR = 4.2 for aripiprazole to a low of PRR = 0.6 for clozapine indicating fewer than expected reports (χ 2 = 1.6 p = 0.203). Grouped together the antipsychotics were borderline with a PRR of 1.9, slightly less than the 2.0 required, and χ2 = 68.5 p<0.01. The results for hypnotics/sedatives were also mixed with strong signals for zolpidem and triazolam, and little or no evidence for lorazepam and midazolam. Among the opioids, only oxycodone showed an association.
Table 3. Psychoactive drugs by drug class and association with violence.* doi:10.1371/journal.pone.0015337.t003
These data show that serious acts of violence towards others were regularly reported as an adverse drug event, and that marked differences were observed among drugs. Varenicline had the strongest association with violence by every measure used in this study. In addition, antidepressant drugs showed consistently elevated risk, even when compared with antipsychotics and mood stabilizers, which are used in psychiatric patients populations in which violent acts may occur. Violence cases as defined here were infrequently reported, accounting for 0.25% of all serious adverse drug events, and confined to a relatively small number of drugs.
This analysis shares many limitations common to studies based on spontaneously reported adverse drug events. The submission of an individual adverse event report does not itself establish causality, only that a reporting individual suspected a relationship existed. However, such reports frequently contribute to a broader assessment of causality. In the computer excerpts, the narrative description of each event is replaced by a series of standardized medical terms, as are adverse events in clinical studies. The quality and detail in each report varies, and the reporting rate for adverse drug events is unknown and believed to vary among types of event, among drugs and over periods of time. 
This study, however, contains numerous features intended to minimize the limitations of adverse event data from postmarketing surveillance. The proportional reporting ratio takes into account two possibilities: a) that wider use or a higher reporting rate exposes a drug to a greater chance of having a violence case attributed, and b) that a higher number of reports might have occurred by chance. The varying results among drugs for smoking cessation and the mood stabilizers show it is unlikely that the violence events are attributed to existing problems in the patient populations treated. Also, the focus of this study was on specific event terms that unequivocally described a violent act or thought – such as homicide or physical assault. By excluding more general adverse event terms such as “aggression” or “anger” many thousands of less specific cases were eliminated under the study criteria. While this means that the study did not count many possible cases of violence towards others (a loss of sensitivity) the restrictive criteria increased specificity. However, given that violent thoughts or actions are not typically attributed to drug therapy or recorded in medical records, the reporting rate for violence cases could be very low. The selected violence cases do not provide a reliable estimate of how often they might occur.
Common and Unusual Features
These events were reported in a patient population that was 41% female and one-half older than age 36. In addition a majority of reports were submitted either by health professionals (primarily MDs) or from foreign sources where reporting is normally limited to health professionals.
While the reported events occurred among drugs used in widely different patient populations, the list of suspects was dominated by drugs that increase the availability of serotonin or dopamine in the brain. Most of the antidepressants increase the availability of serotonin through reuptake inhibition. Varenicline increases the availability of dopamine through partial antagonism of acetylcholine nicotinic receptors.  Sodium oxybate is a dopamine agonist indicated for narcolepsy.  Amphetamines increase concentrations of dopamine and serotonin.  On the other hand, no signal was seen for many common mood stabilizers such valproic acid, carbamazepine, and phenytoin, even though these drugs are used in bipolar patients who may experience psychosis in the acute manic phase and therefore be more prone to violence.
The proportional reporting ratio—our primary measure of elevated risk—showed consistency among drugs with the most similar mechanisms of action. As shown in Table 3, for example, venlafaxine had a PRR of 8.3 and desvenlafaxine a PRR of 7.9 even though the number of total cases and violence cases were different. Similarly citalopram had a PRR of 4.3 and escitalopram a PRR of 5.0. We believe it is also noteworthy that no signal whatever was seen for an overwhelming majority of drugs.
Additional Questions for Study
We have previously examined varenicline’s association with serious psychiatric symptoms including aggression/violence. – The aggression/violence case series for varenicline was consistent with these data but revealed other features that may or may not occur in cases attributed to other drugs. These features include early onset of psychiatric symptoms (usually within a few days), a senseless act of aggression/violence directed at anyone who happened to be near by, and resolution of the symptoms upon discontinuation. A more detailed case series of several hundred cases involving different classes of drugs would greatly improve scientific understanding of this drug adverse event and possibly lead the way towards identifying an at-risk patient population.
These data provide new evidence that acts of violence towards others are a genuine and serious adverse drug event that is associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and serotonin reuptake inhibitors were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional common features.
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