Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, June 04, 2008

Seroxat and Violence

Examples taken from 'Antidepressants and Violence: Problems at the Interface of Medicine and Law' by David Healy, Andrew Herxheimer, David B. Menkes

Case 2
NH was 18 when prescribed paroxetine 20 mg/day by her general practitioner (GP) in Scotland following the death of her grandmother, at the end of November 2001. Within days, she became markedly somnolent, agitated, and emotionally labile. There was an increasing series of arguments at home, and unprecedented aggression. After eight weeks, her parents, concerned about the situation, brought her back to the GP, who increased the dose of paroxetine to 30 mg. One week after the increase of dose and two months after the initial prescription, NH was involved in an incident at a nightclub in which she assaulted another person.

The dose of paroxetine was reduced to 20 mg. Her behaviour remained unstable, disinhibited, and there was at least one suicidal act. Three months later she stopped treatment. She had significant withdrawal problems, but her behaviour normalised. Having been out of work for close to a year she went back to work and has remained in employment since.
NH pled not guilty by virtue of an automatism.

The case was heard in open court where the jury found her guilty but added "that antidepressants had contributed to her actions on the day in question". The judge imposed a suspended sentence, stating that "but for Seroxat you wouldn't be standing here". This case appears to have involved treatment-induced akathisia.

Case 4
MB was a 33-year-old woman with two children who had untreated nervous problems since her teenage years. In 2001 she approached her GP who prescribed paroxetine. An initial 20 mg dose was increased to 30 mg. MB appeared to become more anxious and agitated. This deterioration led to a switch to venlafaxine, which was successively increased to 300 mg/day. During these increases, the medical notes record her as being more anxious and agitated, but did not link this to treatment.

She made plans to take her own and her children's lives, and taking the children for a drive, attached a hosepipe to the exhaust. In the course of two efforts to execute this plan, she thought better of it and informed both the police and child-care authorities what had happened. Her children were taken into care and she was charged with attempted murder.

During the sentencing in the Supreme Court of Western Australia in April 2004, the judge stated there were substantial grounds for implicating venlafaxine in MB's behaviour, and gave her a suspended sentence [41]. This case again appears to involve treatment-induced akathisia.

Case 6
MC started drinking alcohol socially in 1995 at the age of 17. He used ecstasy in 1999 but stopped after a bad experience. He began using cocaine from February 2001, increasing during October through to June 2002, ultimately using 6 g/day for a short time. After July 2002 MC's cocaine use reduced to nil, apart from four minor relapses. He had none after May 2003. MC's alcohol use increased to four to five cans of lager a night in 2002.

He was prescribed paroxetine 20 mg/day for depression in late May 2002. During the first two months on paroxetine he experienced "terrible shaking of the hands; couldn't pick up a glass of milk without spilling it", felt nausea and had "a constant dull headache, as if squinting in sunlight". When he missed a tablet of paroxetine, he wanted to hide under a duvet and to stay away from everybody; his hands shook, and he had headaches and nausea. These symptoms lasted a couple of days, and he learned not to miss a dose.

In September, his GP increased paroxetine to 30 mg "because he was still very anxious", and advised him to take the paroxetine earlier, when its stimulant effects would be more acceptable, rather than late. He was also started on a regular zopiclone prescription at this point to counter paroxetine stimulation. Soon after, another doctor in the practice changed him to the more sedating dothiepin, but after a few weeks he asked to be put back on paroxetine. He subsequently stopped cocaine but began drinking more heavily. Prescriptions of paroxetine and zopiclone continued through to July 2003.

At this stage he was estranged from an ex-partner with whom he had a now 18-month-old daughter. In August 2003, at her home, after ten pints of lager, he took two zopiclone tablets. Following an argument, they had a pint of beer each, during which there was another bout of quarrelling, and she went to bed alone, leaving him to sleep on the sofa. MC may have taken four more zopiclone tablets. He appeared later that night blood-stained in the local police station with his daughter in his arms. The police found his partner dead from multiple stab wounds. He was charged with murder.

In prison paroxetine 30 mg was continued; zopiclone was stopped. During his initial period on paroxetine, and then in prison, MC complained of "terrible nightmares, waking dripping with sweat, soaking the bed". Intense frightening nightmares have been reported regularly in healthy volunteers taking paroxetine. MC had no reported episodes of sleepwalking before using paroxetine, but he had a number of documented episodes of sleepwalking after starting the drug, and two first-degree relatives had a history of sleepwalking. Sleepwalking has been reported in association with zolpidem, a hypnotic related to zopiclone [4244], but no case of sleepwalking on zopiclone has been reported in the scientific literature. However, as noted above, zopiclone is the drug most commonly linked to sleepwalking in Yellow Card reports to the MHRA.

Clearly violence follows domestic arguments, and is a known effect of alcohol, but this case offers grounds also to implicate paroxetine and zopiclone. Zopiclone is known to cause a dose-dependent confusion and amnesia comparable to that found with benzodiazepines [45]. Violence cannot however be attributed to a direct effect of paroxetine alone, since MC had been maintained on this for almost one year with no prior violence. In these circumstances MC pleaded guilty at his trial on 27 February 2006. The judge did not accept that paroxetine and zopiclone had played any part, and sentenced him to 13 years prison. An appeal against the sentence is being prepared.

Case 9
According to an independent forensic report compiled a year after the events for which CP was charged in November 2001, CP was a 12-year-old, 5'2", 95-lb boy with a family background involving considerable social dislocation. Despite the difficulties of his social situation, he had no record of treatment for nervous disorders or of violence or behavioural disturbance. Following an argument with his father at the end of October 2001, he was admitted to a behavioural centre for six days where he was started on paroxetine. His behaviour worsened daily on paroxetine. He was discharged against medical advice to the care of his grandparents, who, when his paroxetine ran out, took him to their primary-care physician who prescribed sertraline 50 mg, increasing this to 100 mg two days before the killings for which CP was charged. The duration of sertraline treatment was three weeks.

Hat Tip to The Truthman for sending me this.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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