'TIGHTER controls' have been placed on the use of acne drug Roaccutane, which has been linked to a number of suicides over the past few years.
A three-year safety review into the medication concluded that it should only be prescribed to patients aged 12–18 years when no prior treatments have worked.
It comes after a number people have died by suicide after taking the drug, leading the grieving parents of a teenage girl to call for a ban in people under 21.
Isotretinoin capsules are also known by the brand names Roaccutane and Reticutan in the UK. It's last-line treatment used to clear up severe forms of acne, especially if there is a risk of permanent scarring.
The Commission on Human Medicines (CHM) carried out the three-year probe on the drug on behalf of the UK's medicine watchdog, the Medicines and Healthcare products Regulatory Agency's (MHRA).
It considered reports from patients and their families who had experience with the medication.
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But the commission concluded that "the gaps in the available evidence meant that it was not possible to say that isotretinoin definitely caused many of the short-term or long-term psychiatric and sexual side effects".
However, it recommended patients and their families should receive better information about the risks of isotretinoin before taking it and that consistent monitoring of a user's psychiatric and sexual health take place so that problems are spotted earlier.
In addition, patients and their families will be given more time to consider the benefits and risks of taking the drug.
The MHRA will also have to implement 'tighter controls' for prescribing isotretinoin to people between 12 and 18.
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The drug will only be greenlit if doctors agree the acne is severe enough to justify it and that other standard treatments have been sufficiently tried.
And the CHM ruled that more research on the psychiatric and sexual side effects of isotretinoin needs is necessary.
Dr Alison Cave, MHRA Chief Safety Officer, said: "No medicine is completely free of risk and the conclusion of the independent CHM is that on balance the benefits of isotretinoin for severe acne continue to outweigh the risks."
But she added: "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 the age of 18 there is additional scrutiny on isotretinoin prescribing."
Side effects
The most common adverse effects are dry lips, dry and fragile skin, and an increased susceptibility to sunburn, an MHRA page on the drug details.
But patients taking the powerful anti-acne drug have also reported depression, anxiety, and psychotic symptoms, the report said, as well as sexual dysfunction, decreased libido and vaginal dryness.
"Very rarely, suicidal thoughts, or suicide attempts, and suicide have been reported," it continued.
The MHRA advised that patients prescribed isotretinoin should be advised of what to do if they feel their mental health is affected or is worsening.
"Patients taking isotretinoin are also recommended to ask family and friends to help watch out for potential symptoms of psychiatric disorders," it added.
Health professionals prescribing the medication need to monitor their patients for signs of depression and refer them for appropriate treatment, taking particular care of those who've been depressed before or have a family history of it.
But it noted that psychiatric symptoms may linger even if patients are taken off the drug.
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.
Though an inquest into her death found no direct link between her death and Roaccutane, Annabel's parents believe the medication drove her to suicide.
Her mum Helen last year issued an emotional plea for Roaccutane to be banned for under 21s, as reported by ITV.
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 estimated last year that "approximately 35,000 individuals receive isotretinoin each year in the UK".
He added that between 87 and 135 reports of side effects suspected to be associated with isotretinoin use have been 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 UK.
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Almost 53,000 isotretinoin prescriptions were dished out by GPs in England in 2022, according to NHS data.
Meanwhile, Yellow Card scheme data recorded 82 suicides among people taking isotretinoin since 1983.
You’re Not Alone: Where to seek help if you need it
If you, or anyone you know, needs help dealing with mental health problems, the following organisations provide support:
- CALM, www.thecalmzone.net, 0800 585 858
- Heads Together, www.headstogether.org.uk
- Mind, www.mind.org.uk, 0300 123 3393
- Papyrus, www.papyrus-uk.org, 0800 068 41 41
- Samaritans, www.samaritans.org, 116 123
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