Health authorities in Britain have called for boosted safety measures when prescribing a treatment for severe acne, after reports that numerous people have committed suicide while taking the drug isotretinoin.
Depression, anxiety and psychotic symptoms have been recorded by others. Cases of sexual dysfunction have also been reported by patients who have been prescribed the medicine, and in some cases, symptoms have continued after patients stopped taking it, reports The Telegraph.
The new review into the treatment, known as Roaccutane, has concluded that the benefits of the drug still outweigh the risks, but extra measures should be taken to improve safety.
Teenager Annabel Wright (15) took her own life just six months after being prescribed a drug to treat her acne, in 2019.
Last year, assistant coroner Jonathan Leach ruled out a direct link between Annabel’s death and isotretinoin, but her parents insisted their daughter died “without warning and without any mitigating circumstances other than she was taking a drug that can cause suicide”.
Gaps in available evidence
The review by the Commission on Human Medicines said the drug, also known by the brand names Rizuderm and Reticutan, was an effective treatment for severe acne that has not responded to the usual treatments.
The expert group said the gaps in the available evidence meant it was not possible to say whether isotretinoin definitely caused many of the short- or long-term psychiatric and sexual side effects reported by patients.
Officials made several recommendations to improve safety surrounding the medicine, which will be taken forward by the Medicines and Healthcare Products Regulatory Agency (MHRA).
These include tighter controls on prescribing the drug to under-18s, giving more information about the risks to patients and their families, and better monitoring of a patient’s psychiatric and sexual health.
‘Significant impact on mental well-being’
Dr Alison Cave, chief safety officer at the MHRA, said: “Uncontrolled and severe acne can have a significant impact on a patient’s mental well-being, and can lead to permanent scarring.
“For these individuals, isotretinoin may be the only effective treatment option.
“No medicine is completely free of risk and the conclusion of the independent Commission on Human Medicines is that, on balance, the benefits of isotretinoin for severe acne continue to outweigh the risks.
“But action should be taken to make sure patients are better aware of them, that they are carefully monitored throughout treatment, and that for patients under 18 there is additional scrutiny on isotretinoin prescribing.”
See more from MedicalBrief archives:
Roaccutane link to 10 suicides leads to UK drugs regulator re-opening inquiry
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How skin oil turns infection-fighting cells into accomplices, making acne bacteria thrive – US study