The Minster Practice, Lichfield
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Last updated 13/03/2007 RoaccutaneThe majority of acne is self treated or managed with the advice of pharmacists or GPs using topical or oral antibacterial agents (e.g. erythromycin or oxytetracycline) with topical keratolytics (e.g. Panoxyl or Quinoderm) or topical retinoids (Retin-A or Isotrex). Roaccutane (isotretinoin) is an oral treatment available for severe acne which affects 0.6-1.4% of young adults. It is only available from hospital specialists and usually dispensed by hospital pharmacies.. It is normally given for 12 - 16 weeks with a claimed 85% cure rate. Although 1 in 5 of responders relapse, repeat courses are not normally recommended. With such spectacular results you may wonder why it is not more widely available. This is because of its many unwanted effects which are not just the alleged link to suicides and depression. The drug is teratogenic (major fetal abnormalities have been reported) so pregnancy must be excluded and effective contraceptive measures must be used from 1 month before therapy through to 4 weeks after therapy is completed. It can affect liver function and the fats in the blood with a link to fatal pancreatitis. Both liver and fats have to be measured before, during and after treatment is completed. Other adverse reactions include dryness and erosion of mucosal surfaces (leading to inflammation of the lips, dry eyes with possible keratitis, dry nose with nose bleeds, dry skin and sensitivity to light, nausea, headache, drowsiness, sweating, seizures, menstrual irregularities, muscle and joint pains, kidney problems with blood and protein in the urine (reversible), both thinning of scalp hair and hirsutism elsewhere, changes in red blood cells, white cells and platelets, visual disturbances (which can be sudden) and others. Establishing whether isotretinoin causes or aggravates depression and thereby linking it to cases of suicide is complicated because of the high prevalence of psychiatric illness among adolescents in general (25%) and patients with acne attending hospital clinics (50%) in particular. In the UK, the manufacturers advise that "Roaccutane may cause depression, psychotic symptoms and rarely suicide attempts and suicide. Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary". Your practice is part of a national framework that provides anonymous long term health data to the UK Medicines & Healthcare Products Regulatory Agency (MHRA). This data can be used to check for links between medication use and a wide range of possible health problems. Professor Jick looked at 2 groups of acne sufferers aged 10-29; one group had received isotretinoin and the other oral antibacterial agents. Their medical histories in the year after the first prescription were compared and no increased risk of depression or psychosis was identified. Unfortunately, the study had design flaws not least being the fact that isotretinoin issued by hospitals may not have appeared on the patients GP records which make up the database, i.e. many users were not identified so the results could be biased in favour of isotretinoin. Also death certification data was not used in preparing the results. Any link between isotretinoin, depression and suicide is likely to be small but the restriction to severe acne will continue in the UK. The situation is changing in the US though. Isotretinoin (called Accutane in the US) is being used increasingly in mild to moderate acne. The increased population exposure will lead to an inevitable increase in unwanted effects and, if these include significant suicide rates, this will be reflected in the legal action for which the country is renowned.
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