New rules over controversial acne drug linked to fears of suicide aims to protect under 18s
NEW measures to prescribe a controversial acne drug linked to dozens of suicides have been introduced to protect young people, health chiefs announced.
As of today (October 31), two medics must sign off on giving on giving the drug, branded as Roaccutane in the UK, under the medical watchdog's new safety measures.
Doctors must also "fully discuss" the risks isotretinoin poses to patients' mental and physical well-being.
And anyone taking it will be monitored for side effects at each follow-up appointment.
The drug is an effective last-line treatment used to clear up severe forms of acne, especially if there is a risk of permanent scarring.
But eighty-two suicides in Britain have been linked to the potent drug - which can be given to kids as young as 12.
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Parents and former patients have previously called for an outright ban on giving the anti-acne drug to under-18s due to the mental health risks.
But a 2020 review into its safety by the Commission on Human Medicines (CHM) concluded the benefits of the drug outweigh the risks.
It considered reports from patients and their families who had experience with the medication.
It concluded it "did not find enough evidence of an increased risk of adverse effects in young people compared to other age groups".
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However, it also said that "the individual experiences of patients and families continue to cause concern".
As a result, the Medicines and Healthcare Products Regulatory Agency (MHRA), which polices the safety of drugs, implemented "tighter controls" for prescribing isotretinoin to people between 12 and 18.
There are already tight restrictions on the use of the drug in mums-to-be as it is known to pose a severe risk to unborn babies.
Dr Alison Cave, MHRA chief safety officer, said: "Like all medicines, isotretinoin may be associated with potential side effects.
"For isotretinoin, there may be possible impacts on mental health and sexual function.
"While not every patient will experience them, the new measures will ensure that patients are well informed, that they are carefully monitored throughout treatment, and that there is additional oversight on isotretinoin prescribing for patients under 18."
Side effects
The most common adverse effects of the anti-acne dry are lips, dry and fragile skin, and increased susceptibility to sunburn, according to the MHRA.
But patients taking the powerful medicine have also reported depression, anxiety, and psychotic symptoms, the report detailed, as well as sexual dysfunction, decreased libido and vaginal dryness.
"Very rarely, suicidal thoughts, or suicide attempts, and suicide have been reported," it continued.
Tragic consequences
Fifteen-year-old Annabel Wright tragically took her own life in May 2019, six months after she was prescribed the powerful acne drug.
An inquest into her death found no direct link between her death and Roaccutane.
However, Annabel's parents believe the medication drove her to suicide.
Her mum, Helen, issued an emotional plea for Roaccutane to be banned for under 21s, as reported by .
The dad of Luke Reeves - who took his own life in 2017 - said his son was "never the same" after taking a four-month course of the drug.
Conservative MP Edward Argar that "approximately 35,000 individuals receive isotretinoin each year in the UK".
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He added that between 87 and 135 reports of side effects suspected to be associated with isotretinoin use have been received each year since 2014 - these are gathered by MHRA's Yellow Card scheme, which collects voluntary reports of adverse reactions to drugs in the UK.
Almost 53,000 isotretinoin prescriptions were dished out by GPs in England in 2022, according to NHS data.