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Friday, 17 May, 2002, 17:00 GMT 18:00 UK
Acne drug 'should be banned'
Serious acne can make teenagers depressed
Serious acne can make teenagers depressed
An acne drug which has been linked to teenagers' deaths should be banned in the UK, campaigners have told health officials.

At a meeting with the Medicines Control Agency, familes said they believed the drug Roaccutane caused mental and physical harm to their children and asked for its UK licence to be withdrawn, pending further research.

MCA statistics show 15 young people have committed suicide in Britain while taking the drug.


There is no evidence that Roaccutane is actually responsible for these cases

Dr Trisha Campbell, Roche
But pharmaceutical company Roche, which makes the drug, rejects the suggestion that the drug is in any way to blame for the suicides or depression and insists the drug is safe.

The delegation included members of the International Roaccutane Action Group and retired consultant anaesthetist Dr Arthur Chow, whose son David formerly took Roaccutane.

The MCA described the meeting as "helpful".

A spokesman added: "Roaccutane is undergoing routine risk benefit review at licence renewal and independent expert advice will be sought from the Committee on Safety of Medicines.

"We will be considering any further information which Dr Chow is able to provide in the course of the review."

IRAG spokesman Liam Grant said they had asked the MCA to force Roche to carry out more studies to find out what effect their product is having on teenagers.

Speaking before the meeting, he said: "In the United States you have to sign a 10 page form which shows that the doctors has described the side effects that you understand them and it also has a book that showing how you can identify depression and so on.

"In the UK there's a one page warning which has the smallest possible print and no explanation as to what is depression how do you identify it and so on .. so there's a whole load of issues we have to talk about with the MCA."

'Mood swings'

Joan Gauge from Cornwall said her son Kevin became severely depressed when he was prescribed Roaccutane.

She told the BBC: "He went from being sociable, lively, totally full of life to being morose depressed just suicidal.

"Every day he cried, he wept, he had tremendous mood swings. The worst thing was for us there was no end in sight."

Kevin started taking the drug in the early 90s. He said he was not warned the side effects could be so severe.
Roaccutane
The tablets carry warnings about possible depression

He said: "I'm 110% convinced that if I hadn't gone on that drug I would not have experienced what I did do.

"It got horrendous. The knife was literally by my wrists.

"I was at such a low stage and could see no way out of it whatsoever. I was thinking really seriously about taking my own life."

In the US, the family of teenager Charles Bishop, who crashed his light aircraft into the side of a building in Tampa, Florida in January this year, blame Roaccutane for his death.

The US has seen public congressional hearings on the controversy surrounding the drug.

Warning

Although Roche denies Roaccutane is to blame for any deaths or serious mental problems, since 1998 the company has been obliged to include a warning on the packaging that "it may cause depression, psychotic symptoms and rarely suicide attempts".

Experts recognise that teenagers with severe acne are prone to depression and suicide.

Dr Trisha Campbell, UK head of medical affairs for Roche, told the BBC around 12m people had taken the drug over the last 20 years.

She said: "Clearly, my heart goes out to any parent of a child who is suffering from depression or who has taken their life.

I do think too many patients are given it

Dr Tony Chu
Dermatologist

"I can understand that they will want to leave no stone unturned to find the cause for it."

She said the drug was "fantastically effective" in treating acne.

Dr Campbell added that there was absolutely no link between the drug had been linked to depression or suicidal tendencies.

She added: "There is no evidence that Roaccutane is actually responsible for these cases.

"There could be umpteen reasons why these cases have occurred."

'Most effective drug'

She said the research the families were calling for was impossible because the cases they cited were very rare.

Dr Campbell added any controlled study of the drug would involve giving people a dummy version of the drug - which would be self-evident because their acne would not clear.

Dr Tony Chu, a dermatologist at the Hammersmith Hospital in London said the drug is the most effective treatment for people with severe acne.

But he said: "I do think it's overused .. I do think too many patients are given it.

"If you've got a patient who is demanding something in your surgery it's often easier and quicker to say oh fine we'll do a blood test these are the warnings and we'll give it to you because it takes less time doing that than actually arguing with them and saying no you can't have it because x, y and z."

 WATCH/LISTEN
 ON THIS STORY
News image The BBC's Niall Dickson
"This really is a very powerful drug"
News image Roche's UK head of medical affairs Dr Trish Campbell
"There could be umpteen reasons why these cases have occurred"
News image Liam Grant, international Roaccutane action group
"Other acne medications haven't produed one study linking them with suicide"
See also:

17 May 02 | Health
Healed by the 'bazooka drug'
19 Nov 98 | Health
Acne drug in suicide claim
18 Jul 00 | Health
Light therapy 'best for acne'
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