Title: Another Warning
Post by: peterb on May 22, 2003, 03:10:21 PM
An acne drug prescribed to teenagers is causing wide debate in the Australian medical community. Julie Robotham reports.
Teenage suicides always leave devastation in their wake, but Christopher's* family has been practically undone, demolished by the thought that the medication that was supposed to help him may have killed him.
The 17-year-old Sydney student was succeeding academically and had reached state level in two sports, and he also made sure to leave time to kick back and socialise. "He had a perspective on life that kept things in balance," his mother told the Herald.
But since puberty, Christopher had been suffering a worsening acne that undermined his self-confidence and affected his emerging interest in dating. "It had been particularly severe. We'd been through skin cleansing, antibiotics," his mother says. "None of that was working."
Christopher's condition and the fact that other drugs had failed qualified him for Roaccutane, the highly potent vitamin A derivative that can frequently clear otherwise intractable cases.
As it did for Christopher. But during a first course he became quiet and moody, and a year later, three months into his second course of the drug, he was becoming noticeably withdrawn and irritable.
His parents at first thought he was reacting to the death of his grandmother, but gradually began to suspect the drug.
As the situation veered out of control, his dermatologist told the family to discontinue the drug. What they were not told was that this would not necessarily end the mental symptoms.
Christopher took his life at the family home, just when things appeared to be getting better. "My husband in particular has suffered terrible anguish. Our marriage has broken up and my husband has had a breakdown. I have lost my job and am unable to sleep," Christopher's mother says.
The fact that Christopher's mood changed both times he began Roaccutane convinces her it was the cause. "In my own mind I am certain," she says.
World concern over the side effects of Roaccutane - also known by its generic name, isotretinoin, and in NSW available only from dermatologists - has centred on the United States.
The Food and Drug Administration (FDA) told a congressional hearing this year it had redoubled its efforts to prevent the drug being prescribed in mild acne, where the potential benefits might not outweigh the risks.
Studies have consistently failed to nail Roaccutane as a cause of depression and suicide in patients, but nor have they been able to rule out the possibility that some people may have an unusual reaction that does lead to terrible psychological effects.
US doctors and the drug's manufacturer, Roche Products, had also been advised to toughen up their policies on preventing birth defects, so that every woman on the program should be having a monthly pregnancy test before receiving her next script. The drug causes horrific facial, bone, heart or lung deformities in about half of babies exposed to it before birth.
In Australia, the drug has been available since 1984, but it is only in recent years that its use has really taken off.
Last year, 155,000 scripts were filled - the equivalent of at least 13,000 patients and probably more. That is double the volume in 1992. The Government spent $22 million on the drug, which is subsidised through the Pharmaceutical Benefits Scheme.
While US authorities attempt to rein in use of Roaccutane (where it is called Accutane), some Australian doctors believe it is time to relax the qualifying criteria here.
Roche convened a panel of dermatologists, headed by Sydney University's Associate Professor Alan Cooper, to consult to the company - including on how they would view extending the availability of the drug to people whose acne was mild or moderate but who were nevertheless suffering psychologically as a consequence. The nine-doctor group responded favourably, concluding the range of patients eligible "needs to be expanded".
Dr Alan Watson, convener of the scientific advisory committee of the Australasian College of Dermatologists, says the Cooper panel's conclusions have opened up an important debate.
"A lot of people prescribing it would say the recommendations are too narrow because you have to have [acne with] cysts."
It was probable some of the increased prescribing in Australia was a consequence of doctors interpreting the restrictions loosely, and that 40 per cent of all use in the US was for "lesser indications" than true cystic acne. And there was also a trend for people to stay on it long-term, sometimes for many years: "They get to the stage where they never want another pimple."
Watson emphasises that for many patients, the potential benefit is huge: "It has a direct effect on the sebaceous gland, so that it doesn't produce as much oil. It corrects the abnormal, horny material that blocks the pores and it gets rid of bacteria in the sebaceous follicle. It shrinks the sebaceous gland activity back to pre-pubertal levels."
With the help of the Royal Australian and New Zealand College of Psychiatrists, Watson's group developed its own paper on links between mood disorders and Roaccutane, which it recently circulated to its nearly 300 dermatologist members.
According to the statement, "At this stage, careful search of the available literature suggests that there is no conclusively proven association but that a possible idiosyncratic reaction in a very small number of patients cannot be excluded."
The age of patients - Roaccutane users are predominantly adolescents and young adults - coincides with a time of high risk for depression and suicide, Watson's paper goes on to say. Accordingly, dermatologists, who may be the only doctor the young person sees regularly, should be on the look-out for depressive symptoms, and ask the patient about changes to mood at each visit. They should also raise awareness among GPs.
The FDA's Centre for Drug Evaluation and Research goes further. In detailed advice to prescribers it reports bluntly: "Awareness of signs and symptoms may save your patient's life." And it warns doctors against putting their heads in the sand by writing off problems as a passing adolescent phase: "It may be difficult to decide whether erratic behaviour may warrant psychiatric evaluation, especially if that behaviour seems to be age-appropriate in a teenager. However, as with any specialised problem, you may identify patients who seem to need more than dermatologic care, and you may need to refer them to a specialist."
A spokesman for the Therapeutic Goods Administration says it has begun requiring manufacturers' (generic versions of isotretinoin are now on the Australian market) "to include clear descriptions of the symptoms of depression" in their patient literature and to ensure it is distributed with each pack. He says the Australian Drug Evaluation Committee reviewed Roaccutane in February, and it decided the current patient information requirements were adequate.
For Cooper, the chairman of the committee that recommended wider use for more patients, more controversy will only mean more teenagers sentenced to live with the agony of what they perceive as a dreadful deformity. "You get parents looking at kids with shocking acne saying, 'I can't let them be treated'. People suffer. They're completely under their parents' control."
* Name and some personal details have been changed.
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Title: Re:Another Warning
Post by: Nick on May 22, 2003, 06:37:52 PM
That's very distressing to read. My sympathy to the family.
I know that there are action groups trying to get roaccutane banned completely. To date I haven't managed to find any information or statistics about the exact number of suicides in roaccutane users to see how they compare to non-users.
If anyone stumbles on them i'd be very interested to see the results. |
Title: Re:Another Warning
Post by: fishs on May 22, 2003, 10:00:26 PM
:hi:
Peter .
Thanks for this post .. I am very aware of this case ..
It has been debated in the news here and on sky and other TV ..
This is a good post to bring this on board for other members ..
I have seen some horrific stories about this Drug and I Personally think It has far too many ramifications to prescribe to any youngster.. for any condition.
Kids here and In Australia are actually selling their allocated daily lot to other Kids in the playground . Thats how bad it is .. I kid you not .. Major .. Major problem..
Thanks for posting Peter..
Fish |
Title: Re:Another Warning
Post by: peterb on May 22, 2003, 10:09:23 PM
That's very distressing to read. My sympathy to the family.
I know that there are action groups trying to get roaccutane banned completely. To date I haven't managed to find any information or statistics about the exact number of suicides in roaccutane users to see how they compare to non-users.
If anyone stumbles on them i'd be very interested to see the results.
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Nick I have found this, with some facts and figures.
http://www.accutaneaction.com/leeds.htm |
Title: Re:Another Warning
Post by: electric_ian on May 22, 2003, 10:30:27 PM
That makes some scarry reading Peter..
Ian |
Title: Re:Another Warning
Post by: Celery Peach on May 23, 2003, 09:13:34 AM
Thank you for posting this article Peter.
I am very concerned that they are offering this drug to HS patients, many of which are depressed. It is also called Accutane here in UK. I myself was offered this drug, but refused, the research I have done shows little benefits to HS. Handle this drug like dynamite, it is shocking that the largest group of users are adolescents, this is a hard enough time allready. Besides the psychlogical effects it also has a dramatic drying effect on skin and organs, in some incidences to a dibilatating degree. I have also read testimonies from people that are still suffering the side effects 5 years after taking it. |
Title: Re:Another Warning
Post by: fishs on May 23, 2003, 09:42:46 AM
:hi:
Thanks Celery .
You are correct .. Called by a number of names .. It's a retinoid ..
As I posted above We have Kids swapping and selling this in the playground..
It is also now being prescribed to kids who are Attention Defficate .
and kids are conning thier parents etc so they can flog it at school.
They are also selling here and in Aust their "Ritalin " and swapping that for ro or accutane etc .. Another dynamite drug being given to kids for depression and attention defficate syndrome.. ( They give ritalin here to kids like lollies)
You are correct .. These drugs are dangerous .. Very very dangerous ..
and you have to seriously question the authorities, docs and the parents .
Good post Celery.. I share your concerns
Fish
Fish |
Title: Re:Another Warning
Post by: Alison on May 23, 2003, 09:52:24 AM
ian used roactine ,
they knew he had suffered wiv depression befor takeing it too :-X
| As I posted above We have Kids swapping and selling this in the playground |
|
now that is scarey |
Title: Re:Another Warning
Post by: Monika on May 24, 2003, 01:45:36 AM
| Jerod and I both took Accutane as teens. For us, it was the only thing that worked. Neither of us regret taking it. Especially in Jerod's case, I don't know what he would have done without it (he had the severe, painful-to-the-touch kind of acne). I think rather than ban it completely, doctors should be extremely cautious about who they prescribe it to, and watch those patients carefully. I had to go to the doctor every 3 weeks, and they were strict about that, to be evaluated... not sure if they still do that. Jerod said he also went regularly for evaluations while on Accutane, but can't remember how often he went. |
Title: Re:Another Warning
Post by: Celery Peach on May 24, 2003, 09:42:55 AM
:hi:
Hi Monika, Im glad it has helped you and Jerod, and I cant deny that it has been a wonder drug to people with stubborn and painful acne. It sounds like you and Jerod had the correct monitoring whilst taking it, and I think that is the key.
I feel though, as far as HS is concerned, very little good results are shown, for the risks taken. My own derms figures were 1 in 10 showed a little improvement.
I wouldnt want it banned either Monika, but , as you say, doctors should be extremely cautious and family involved and well informed. :) |
Title: Re:Another Warning
Post by: Monika on May 24, 2003, 04:26:25 PM
| CP, I definitely think it's inappropriate (and kind of weird) that they're prescribing it for HS. Especially when it's obviously not working very well (hardly at all it sounds like like). |
Title: Re:Another Warning
Post by: Celery Peach on May 24, 2003, 05:29:17 PM
:hi: Hi Monika
Yes, it is pretty weird Mon, and frustrating >:( I think that the Derms & Docs are at a loss as to what to give us HS'ers. HS is classed as an 'orphan illness' which basically means that there is not enough patients to warrent doing any proper research. HS is thought to be a rare disease, though I personally think that it is more common than documented, people are ashamed/ embarressed because it nearly allways starts in the groin area. Sometimes people only have a mild form, 3 or 4 lessions a year, which they deal with them themselves, as I did myself all through my teens & twenties, untill it bacame much worse. Also, if they do go to their GP, they dont allways get the correct diagnosis, often mistaken for Sebacious cysts or Acne. All credit to the Yahoo HS Site, there are a lot of people getting information together, and have produced leaflets to print, they write often to TV and the Press for publication, but so far few have taken up the topic.
I have had to become my own HS Specialist, taking advice from other sufferers and looking for fresh ideas everywhere. I took Tetracycline Antibiotics for 3 years (which are for acne) without question from the Derm, only to find that when I came off them, the only affect they were having, was to give me IBS.
It's a daunting realization to find that the Derms havnt any treatments that actually work, and I stuggled with that for a while, got me really down. I'm just glad that there are groups like Skincell and the HS group that can offer the information & SUPPORT. :hug: They really are a lifeline, and given me a positive attitude.
Sorry, got my waffling head on again ??? My point was that I think the Derms prescribe Acne treatment, because patients demand they do something and Derms have to seen as 'doing' something. It becomes dangerous tho when prescribing drugs such as Accutane, as some patients do not have the access to the info we have. The Document I posted here says that around 80% of HS patients are clinically depressed, it could just push them over the edge, especially if it does not help the HS. |
Title: Re:Another Warning
Post by: Nick on May 24, 2003, 09:21:06 PM
CP,
You call that waffling?
I call it a damn good post - very informative :hug:
It is frightening that the drug is under attack and calls being made for proper investigations btu is still on general release, and what Fish says about being peddled in the schools is absolutely shocking :o
Surely there should be better controls and more psychiatric tests on the patients to make sure they are able to handle the drug ? |
Title: Re:Another Warning
Post by: fishs on May 24, 2003, 10:12:47 PM
:hi:
Gidday Celery.
Yes I agree with Nick .. You are not waffling .. I also think Your post is excellent ..
You have raised some very pertinant points here .. and very valid.
Keep the info comming .
Fish |
Title: Re:Another Warning
Post by: Monika on May 24, 2003, 11:45:45 PM
| Surely there should be better controls and more psychiatric tests on the patients to make sure they are able to handle the drug ? |
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That's a good point Nick... it seems that they have relaxed a LOT since when Jerod and I took it. I lived in Maryland then, he was in Florida. Yet we both still underwent the same kind of testing and scrutiny from our doctors while on the medicine. Now, about ten years later, it seems those controls are gone. With all the problems associated with Accutane, you'd think they'd go back to the stricter controls. :-\ |
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