SSRI: Seroxat and Prozac 'can make people homicidal'

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SSRI-Research@

Tue, 21 Sep 2004 23:10:13 -0400

 

[sSRI-Research] " Paxil & Prozac Can Make People Homicidal " :

 

article: Guardian, UK

Paragraph four reads: " Dr Healy, director of the north Wales

department of psychological medicine, says he has seen data from the

clinical trials that show even some healthy volunteers - people with

no illness at all volunteering to take part in the earliest safety

trials of the drugs - became unaccountably aggressive. Their reaction

is coded as " hostile " which can include homicidal behaviour and

serious aggression.

 

 

http://www.guardian.co.uk/uk_news/story/0,3604,1309077,00.html

 

 

Seroxat and Prozac 'can make people homicidal'

 

Doctor who found suicide risk says experts ignoring danger

 

Sarah Boseley, health editor

Tuesday September 21, 2004

The Guardian

 

Evidence that antidepressant drugs like Seroxat and Prozac could make

people homicidal is being ignored by the body responsible for

regulating medicines in the UK, a leading expert said yesterday.

 

The charge came from David Healy, an expert on psychiatric drugs from

north Wales whose warnings that the drugs could cause suicide prompted

a major inquiry. That investigation, by an expert working group of the

Medicines and Healthcare Products Regulatory Authority, led to the

entire class of drugs except Prozac being banned last year from use in

children.

 

The expert working group has gone on to look at suicides in adults

taking any of the drugs known as SSRIs (selective serotonin reuptake

inhibitors). But Dr Healy says that they are overlooking very

important data relating to a set of further dangerous side-effects.

 

Dr Healy, director of the north Wales department of psychological

medicine, says he has seen data from the clinical trials that show

even some healthy volunteers - people with no illness at all

volunteering to take part in the earliest safety trials of the drugs -

became unaccountably aggressive. Their reaction is coded as " hostile "

which can include homicidal behaviour and serious aggression.

 

" I think there is very clear evidence for all of the SSRI group of

drugs that in addition to making people suicidal, they can make people

homicidal or seriously aggressive and the data have been sitting in

the MHRA's files on this issue, " he said.

 

" It is there for children across a range of different problems, it is

there for healthy volunteers and a range of adults and the MHRA has

paid no heed to this. "

 

 

The healthy volunteer trials of the British drug Seroxat took place in

the late 1980s or early 1990s. Of the 271 fit and well individuals,

three became hostile, compared with none on an inactive placebo - a

rate of 1.1%, which although small could translate to very many cases

among the 50m worldwide who have taken Seroxat over the last 15 years.

 

The signal from the healthy volunteer trials is supported by data from

trials in children on Seroxat for obsessive compulsive disorder (OCD),

depression and social phobia. Children taking part amounted to 738 on

Seroxat and 647 on placebo. Of those, there were 27 hostile events on

Seroxat and only four on placebo. Taking the children with OCD alone,

those on the drug were 17 times more likely to become aggressive than

those on placebo.

 

Trials of Seroxat (known generically as paroxetine) for women with

pre-menstrual syndrome show a similar pattern, with five hostile acts

on the drug and none on placebo.

 

But, says Dr Healy, the MHRA officials appear not to have picked up

the signals from all the separate trials and are failing to see the

whole picture.

 

A number of cases where people have argued their aggressive acts were

due to one of the SSRI antidepressants have come to court. In the most

dramatic, a US jury in 2001 found that GlaxoSmithKline's drug was

partly responsible for the murders committed by Donald Schell. After

two days on Paxil (as Seroxat is named in the USA), Schell killed his

wife, his daughter and his baby granddaughter before shooting himself

dead. GlaxoSmithKline was ordered to pay $8m (£4.5m) to the remaining

family members.

 

GlaxoSmithKline last night denied that its drug caused adults to

become hostile, although it acknowledged there had been a problem in

the children's trials. " There is no compelling evidence from our

clinical trials that Seroxat causes hostile behaviour in adults. When

you put the results from all the clinical trials together there is no

difference between the rates of hostility for adult patients taking

Seroxat and the patients taking placebo, or dummy pill. This data has

been shared with regulators including the MHRA, " said a spokesman.

 

The MHRA said yesterday that the working group had looked at the data

on events coded as " hostility " in its analysis of the children's

trials and that it had acted to prevent the use of most SSRIs in

children as a result of all the data, including that on hostility.

" The review of adult data is ongoing, " it said.