UK slow to clamp down on drug that causes stroke in elderly

[Guest guest]

http://politics.guardian.co.uk/publicservices/story/0,11032,1168588,00.html

Man I love the Brtish press

UK slow to clamp down on drug that causes stroke in elderly

Boseley

Saturday March 13, 2004

The Guardian

It took the government's Committee on Safety of Medicines seven months to act on

comprehensive evidence that a schizophrenia drug widely given to control the

behaviour of elderly people in care homes could cause them to have a stroke.

Last week the advisory body recommended doctors should not prescribe risperidone

or olanzapine for such patients. But the manufacturer of risperidone - brand

name Risperdal - gave the CSM full data about the risks last July.

Canadian and US drug regulators acted swiftly on early evidence from the

manufacturers that Risperdal might cause death in the elderly.

In October 2002 Janssen-Ortho wrote to all health professionals, at the request

of the Canadian authorities. In April 2003 the US regulators took similar

action.

The vice-president of medical affairs of Janssen Pharmaceutica in New Jersey

wrote: " [strokes,] including fatalities, were reported in patients (mean age 85

years; range 73-97) in trials of risperidone in elderly patients with

dementia-related psychosis.

" In placebo-controlled trials, there was a significantly higher incidence of

cerebrovascular adverse events in patients treated with risperidone compared to

patients treated with placebo. Risperdal has not been shown to be safe or

effective in the treatment of patients with dementia-related psychosis. "

But evidence came to light because the company carried out clinical trials in

the hope of applying for a licence to market Risperdal for behavioural problems

in the elderly.

Doctors were already using Risperdal on such patients.

Donnelly, medical director of Janssen in the UK, said that when the first

data came in there was " an imbalance " which they reported to the authorities

worldwide.

That led to the letters in Canada and the US. By last summer they had the full

trial data. This went to the UK's Medicines and Healthcare Products Regulatory

Authority (MHRA). A Department of Health spokesman said the MHRA had acted at

the same time as the Canadians and the Americans by adding a warning to doctors'

product information that there might be an increased risk of stroke.

In April last year, he said, the company wrote to psycho-geriatricians in the

UK.

But Robin Keen, who has investigated the worldwide advice since his mother,

Urene, suffered a severe stroke while on Risperdal nine months ago, said the

warnings would not necessarily have been noticed by doctors, and certainly did

not go out to patients.

He added: " Practitioners may argue that many drugs have inherent risks, though

when knowledge of that risk is clearly available, supported by the presence of

clinical trial results, and even more so when that risk is of a life-threatening

magnitude, then surely the patient, or that patient's relatives, have the right

to that information in order to make an informed decision. "

The health department said the MHRA had commissioned its own analysis of all the

drug data in December after getting reports that those on the drugs were

suffering strokes. It received the conclusions in January, and put out its

advice to doctors last week.

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

http://politics.guardian.co.uk/publicservices/story/0,11032,1168588,00.html

Man I love the Brtish press

UK slow to clamp down on drug that causes stroke in elderly

Boseley

Saturday March 13, 2004

The Guardian

It took the government's Committee on Safety of Medicines seven months to act on

comprehensive evidence that a schizophrenia drug widely given to control the

behaviour of elderly people in care homes could cause them to have a stroke.

Last week the advisory body recommended doctors should not prescribe risperidone

or olanzapine for such patients. But the manufacturer of risperidone - brand

name Risperdal - gave the CSM full data about the risks last July.

Canadian and US drug regulators acted swiftly on early evidence from the

manufacturers that Risperdal might cause death in the elderly.

In October 2002 Janssen-Ortho wrote to all health professionals, at the request

of the Canadian authorities. In April 2003 the US regulators took similar

action.

The vice-president of medical affairs of Janssen Pharmaceutica in New Jersey

wrote: " [strokes,] including fatalities, were reported in patients (mean age 85

years; range 73-97) in trials of risperidone in elderly patients with

dementia-related psychosis.

" In placebo-controlled trials, there was a significantly higher incidence of

cerebrovascular adverse events in patients treated with risperidone compared to

patients treated with placebo. Risperdal has not been shown to be safe or

effective in the treatment of patients with dementia-related psychosis. "

But evidence came to light because the company carried out clinical trials in

the hope of applying for a licence to market Risperdal for behavioural problems

in the elderly.

Doctors were already using Risperdal on such patients.

Donnelly, medical director of Janssen in the UK, said that when the first

data came in there was " an imbalance " which they reported to the authorities

worldwide.

That led to the letters in Canada and the US. By last summer they had the full

trial data. This went to the UK's Medicines and Healthcare Products Regulatory

Authority (MHRA). A Department of Health spokesman said the MHRA had acted at

the same time as the Canadians and the Americans by adding a warning to doctors'

product information that there might be an increased risk of stroke.

In April last year, he said, the company wrote to psycho-geriatricians in the

UK.

But Robin Keen, who has investigated the worldwide advice since his mother,

Urene, suffered a severe stroke while on Risperdal nine months ago, said the

warnings would not necessarily have been noticed by doctors, and certainly did

not go out to patients.

He added: " Practitioners may argue that many drugs have inherent risks, though

when knowledge of that risk is clearly available, supported by the presence of

clinical trial results, and even more so when that risk is of a life-threatening

magnitude, then surely the patient, or that patient's relatives, have the right

to that information in order to make an informed decision. "

The health department said the MHRA had commissioned its own analysis of all the

drug data in December after getting reports that those on the drugs were

suffering strokes. It received the conclusions in January, and put out its

advice to doctors last week.

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

http://politics.guardian.co.uk/publicservices/story/0,11032,1168588,00.html

Man I love the Brtish press

UK slow to clamp down on drug that causes stroke in elderly

Boseley

Saturday March 13, 2004

The Guardian

It took the government's Committee on Safety of Medicines seven months to act on

comprehensive evidence that a schizophrenia drug widely given to control the

behaviour of elderly people in care homes could cause them to have a stroke.

Last week the advisory body recommended doctors should not prescribe risperidone

or olanzapine for such patients. But the manufacturer of risperidone - brand

name Risperdal - gave the CSM full data about the risks last July.

Canadian and US drug regulators acted swiftly on early evidence from the

manufacturers that Risperdal might cause death in the elderly.

In October 2002 Janssen-Ortho wrote to all health professionals, at the request

of the Canadian authorities. In April 2003 the US regulators took similar

action.

The vice-president of medical affairs of Janssen Pharmaceutica in New Jersey

wrote: " [strokes,] including fatalities, were reported in patients (mean age 85

years; range 73-97) in trials of risperidone in elderly patients with

dementia-related psychosis.

" In placebo-controlled trials, there was a significantly higher incidence of

cerebrovascular adverse events in patients treated with risperidone compared to

patients treated with placebo. Risperdal has not been shown to be safe or

effective in the treatment of patients with dementia-related psychosis. "

But evidence came to light because the company carried out clinical trials in

the hope of applying for a licence to market Risperdal for behavioural problems

in the elderly.

Doctors were already using Risperdal on such patients.

Donnelly, medical director of Janssen in the UK, said that when the first

data came in there was " an imbalance " which they reported to the authorities

worldwide.

That led to the letters in Canada and the US. By last summer they had the full

trial data. This went to the UK's Medicines and Healthcare Products Regulatory

Authority (MHRA). A Department of Health spokesman said the MHRA had acted at

the same time as the Canadians and the Americans by adding a warning to doctors'

product information that there might be an increased risk of stroke.

In April last year, he said, the company wrote to psycho-geriatricians in the

UK.

But Robin Keen, who has investigated the worldwide advice since his mother,

Urene, suffered a severe stroke while on Risperdal nine months ago, said the

warnings would not necessarily have been noticed by doctors, and certainly did

not go out to patients.

He added: " Practitioners may argue that many drugs have inherent risks, though

when knowledge of that risk is clearly available, supported by the presence of

clinical trial results, and even more so when that risk is of a life-threatening

magnitude, then surely the patient, or that patient's relatives, have the right

to that information in order to make an informed decision. "

The health department said the MHRA had commissioned its own analysis of all the

drug data in December after getting reports that those on the drugs were

suffering strokes. It received the conclusions in January, and put out its

advice to doctors last week.

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

[Guest guest]

http://politics.guardian.co.uk/publicservices/story/0,11032,1168588,00.html

Man I love the Brtish press

UK slow to clamp down on drug that causes stroke in elderly

Boseley

Saturday March 13, 2004

The Guardian

It took the government's Committee on Safety of Medicines seven months to act on

comprehensive evidence that a schizophrenia drug widely given to control the

behaviour of elderly people in care homes could cause them to have a stroke.

Last week the advisory body recommended doctors should not prescribe risperidone

or olanzapine for such patients. But the manufacturer of risperidone - brand

name Risperdal - gave the CSM full data about the risks last July.

Canadian and US drug regulators acted swiftly on early evidence from the

manufacturers that Risperdal might cause death in the elderly.

In October 2002 Janssen-Ortho wrote to all health professionals, at the request

of the Canadian authorities. In April 2003 the US regulators took similar

action.

The vice-president of medical affairs of Janssen Pharmaceutica in New Jersey

wrote: " [strokes,] including fatalities, were reported in patients (mean age 85

years; range 73-97) in trials of risperidone in elderly patients with

dementia-related psychosis.

" In placebo-controlled trials, there was a significantly higher incidence of

cerebrovascular adverse events in patients treated with risperidone compared to

patients treated with placebo. Risperdal has not been shown to be safe or

effective in the treatment of patients with dementia-related psychosis. "

But evidence came to light because the company carried out clinical trials in

the hope of applying for a licence to market Risperdal for behavioural problems

in the elderly.

Doctors were already using Risperdal on such patients.

Donnelly, medical director of Janssen in the UK, said that when the first

data came in there was " an imbalance " which they reported to the authorities

worldwide.

That led to the letters in Canada and the US. By last summer they had the full

trial data. This went to the UK's Medicines and Healthcare Products Regulatory

Authority (MHRA). A Department of Health spokesman said the MHRA had acted at

the same time as the Canadians and the Americans by adding a warning to doctors'

product information that there might be an increased risk of stroke.

In April last year, he said, the company wrote to psycho-geriatricians in the

UK.

But Robin Keen, who has investigated the worldwide advice since his mother,

Urene, suffered a severe stroke while on Risperdal nine months ago, said the

warnings would not necessarily have been noticed by doctors, and certainly did

not go out to patients.

He added: " Practitioners may argue that many drugs have inherent risks, though

when knowledge of that risk is clearly available, supported by the presence of

clinical trial results, and even more so when that risk is of a life-threatening

magnitude, then surely the patient, or that patient's relatives, have the right

to that information in order to make an informed decision. "

The health department said the MHRA had commissioned its own analysis of all the

drug data in December after getting reports that those on the drugs were

suffering strokes. It received the conclusions in January, and put out its

advice to doctors last week.

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss