Some young people are DYING FOR CLEAR SKIN

Sometimes even decades after having taken ROACCUTANE (ISOTRETINOIN)

RoAccutane (Isotretinoin) is an acne drug for sufferers of severe cystic acne.
This medication can have devastating side effects.

Before using this medication just be aware of the risks...

The Facts:-

1. This drug was developed as a chemotherapy drug but it was coincidentally discovered that it improved skin condition in those who used it. It was then given to those without cancer but with acne. The manufacturers Roche openly admit they do not know how it works. In some people it causes irreversible damage in the brain and suicide can result. This is what happened to our sons and many others, apparently 3,000 at the last count worldwide.

2. Youngsters are so keen to get rid of their acne because of the stigma and bullying that it can cause, that they are prepared to risk their health and ignore warnings of possible suicidal or other severe life limiting side effects – so they need to be protected as some patients are epigenetically susceptible to this drug but as yet, cannot be identified.

3. In the USA patients have to sign an informed consent form which require them to initial the clause that states that Accutane could cause them to have suicidal thoughts or end their own lives and they must be monitored each month. Patients do not have to sign anything like this in the UK.

4. There are many severe side effects associated with this drug and for women who get pregnant whilst on this drug it means having an abortion as the risk of a deformed baby is almost guaranteed as it is teratogenic, meaning that if you take it during pregnancy about 50% of babies exposed will have neurological damage. Because of this risk the MHRA (Medicines Healthcare Products Regulatory Agency) and the BAD (British Association of Dermatologists) have strict guidelines to be followed by Dermatologists who are the ones prescribing the drug and Pharmacists who dispense it. They should follow a set system of monitoring and there is a Pregnancy Prevention Programme for women which users have to sign up to.

5. However, not only is there a severe shortage of dermatologists in the UK (some 20%) which inevitably makes monitoring more difficult, but worse still, the drug is readily available on the Internet (even in the more dangerous higher doses) with no warnings or monitoring . The warnings are inside the packet but once opened and read, no refund would be likely to be given if returned, and in any case higher doses tend to be sold in larger quantities with higher prices (well over £100) so the patients are most unlikely to read the leaflet until too late.

6. Patients with severe acne are not likely to report a side effect, unless they have to because it is so severe, as they do not want to be taken off a drug that they feel is helping to clear their acne. Young patients are also less likely to heed written warnings in packets, as clearing the acne is more important to them than anything, so they are more likely to take the risk. So they need protecting from themselves and the dangers of this drug.

7. Patients may report problems to their dermatologists but if they are over 18 years old they may not share these with their parents so if they start having strange mental symptoms, carers and friends will not understand and put this down to bad behaviour which can cause family rifts and problems of not being believed when actually suicidal.

8. How can it be possible that such a potentially dangerous drug (one of the world’s top 10 most dangerous drugs according to the FDA list) with such possible severe side effects, can be allowed to be bought now on the Internet, thus bypassing the official monitoring and essential prescribing advice given out by the MHRA and BAD in the UK. This is the safety net which is supposed to be adhered to, but if not, we are allowing the exposure of mainly young patients to great risk just through ignorance, attracted by the desire for clear skin.

9. Accutane – as it is called in the USA (Isotretinoin) was withdrawn by Roche in 2009 after many lawsuits for inflammatory bowel disease with huge payouts there for compensation. Following research carried out by Dr Doug Bremner in the USA who took brain scans before and after treatment, it could be clearly seen that Accutane was having an unwanted effect on brain function as it was affecting the frontal lobes.

10. Roche say there are hundreds of thousands of prescriptions for RoAccutane each year and they insist there is no causal link to suicide (they cannot prove this however) and this appears to be accepted by the MHRA and the BMA.

11. The MHRA claim to be keeping a close watch on the use of this drug but they are not requiring coroners to report on the use of Isotretinoin in suicide cases. We would expect the MHRA also to have figures for people with inflammatory bowel disease following the problems in the USA as well as figures for other very severe side effects. Apparently this is not happening at present, so the public are left in ignorance.

The only safe way forward is to ban this drug and offer alternative forms of treatment such as Blue Light and Laser treatment funded by the NHS. Science needs to do far more research to discover other safe alternatives, coupled with promoting healthy eating.

Under reporting and trying to raise awareness

13. Coroners’ courts repeatedly report that the evidence is only anecdotal about those having taken this drug and then committing suicide, despite family protestations that they were perfectly healthy beforehand, so no investigations are carried out, and no reports sent to the MHRA.

14. The above shows the problems of under reporting – how can records of deaths be accurate when coroners are not required to ask in all suicide cases if Isotretinoin has been taken, or to require brain scans to be carried out which could show changes in the frontal lobes.

15. 54% of the population are affected by skin disease each year and 4,000 deaths annually are attributed to this, 1 in 6 have self harmed and 17% have contemplated or attempted suicide – of this number it would be interesting to know how many have been taking Isotretinoin.

16. The three stigmas of suffering patients are:- severe acne, mental illness and suicide; these mean that there are families who have not spoken up because of the shame and pain and have never understood the possible link between this drug and suicide after the deaths of loved ones.

17. The above shows the problem of under-reporting:-

Many patients taking a drug for acne naturally don’t associate their psychotic feelings with it.

18. This again underlines the importance of trying to obtain more accurate figures of the links of suicide to having taken this drug.

19. Government is setting up a research group in May/June 2014 following pressure from MPs, to look again at RoAccutane (Isotretinoin) and its side effects.

Conclusion

If a patient gets severe side effects like depression or psychosis he or she probably will not be understood by psychiatrists and dermatologists who generally do not credit the possible likely link between the drug and the side effects. One terrible side effect can be erectile dysfunction but this is such a sensitive issue that few people dare mention it. In some cases this can be permanent. Also sexual dysfunction in women. No warnings about this are given in the packaging.

A car manufacturer has to take responsibility when things go wrong with their products but drug companies push the burden of proof of damage onto the patient who may be too ill and embarrassed to understand and cope with it.

Additional Reading