Why do top skin doctors want to overturn strict new safety rules on the powerful acne drug that’s been blamed for teen suicides?

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Written By Rivera Claudia

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  • Two specialists have to sign a prescription before isotretinoin can be given to anyone under 18
  • Dermatologists want regulators to row back on the tough new guidance
  • But parents of youngsters who have died while taking the drug say it is ‘dangerous’ 

Top skin doctors are urging drug chiefs to rethink strict new rules which hinder them handing out a powerful acne drug to patients who need it.

Safety measures introduced in October for isotretinoin, which is sold under the name Roaccutane, require two skin specialists to sign a prescription before it can be given to anyone under 18 – the only drug to be subject to such a stringent requirement.

The change came after it emerged the drug’s debilitating side effects may have led to the suicides of several young people.

Clinicians have also been ordered to warn patients about isotretinoin’s potential to trigger serious mental health problems such as psychosis, as well as sexual dysfunction.

But dermatologists are pressing regulators to row back on the ‘problematic’ guidance, the Mail has learned.

Annabel Wright with her mother Helen, who says the acne drug is ‘dangerous’. Annabel took her own life in 2019, at the age of 15

Many doctors are ‘very unhappy’ about the requirement for a double signature to confirm there is no other appropriate effective treatment. Sources claim it risks patient safety by hampering their ability to offer vital treatment, adding that the drug has been unfairly demonised.

The British Association of Dermatologists (BAD) confirmed last night it was in talks with safety watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), over ‘parts of the new regulations that may have a negative impact on patients’.

One senior consultant, who asked to remain anonymous, adds: ‘There have been unfair attacks on a drug that’s been around for decades and is a game-changer for people with severe acne. Any restriction has a chance of causing patients harm. Acne can cause people psychological damage, sometimes to the point where they can’t even leave the house.

‘The vast majority of people have a great response to isotretinoin, but sadly they are the people you don’t hear from.’

Luke Reeves, 21, died in 2016

Luke Reeves, 21, died in 2016

However, some campaigners pushing for the drug to be banned and argue the current regulations don’t go far enough, with one devastated father of a young patient who took his own life saying it was ‘utterly incredulous’ that doctors might be seeking to relax the rules.

Jonathan Medland, 67, from Barnstaple, lost his son Jon to suicide in 2004 shortly after he stopped taking isotretinoin.

Jon Medland, 22, died in 2004

Jon Medland, 22, died in 2004

He is certain the drug contributed to the 22-year-old medical student’s death and says his son had never shown signs of depression before the treatment.

Melissa Martin-Hughes, 18, died in 2010

Melissa Martin-Hughes, 18, died in 2010

‘We were a loving, happy family,’ he says. ‘Our life as we knew it ended the moment Jon died.’

Mr Medland accuses doctors of dishing the drug out ‘like Smarties because it’s an easy fix’.

Isotretinoin was first licensed in 1983 and is regarded as the gold-standard treatment for severe acne that failed to respond to other medicines. Currently taken by 48,000 people in the UK, it works by preventing the skin from producing oils that acne-causing bacteria feed on.

Studies suggest patients’ skin clears up after just four months and the majority are virtually ‘cured’.

However, the drug can be prescribed only by dermatologists due to its potential side effects. The most common include dry skin, rashes, headaches and back pain.

Patients must also be monitored with regular blood tests, because in rare cases it can damage the liver, and women are advised not to conceive while on the drug due to possible birth defects.

In 2019, the MHRA announced a safety review on isotretinoin following a rise in reports of adverse reactions to its Yellow Card scheme, which allows healthcare professionals as well as the public to flag up adverse effects of medicines via its website.

Since isotretinoin was approved it has triggered more than 8,000 such reports, ranging from vision problems and anaemia to joint and muscle pain and even seizures.

However, one in four complaints are for anxiety, depression, behavioural disturbances and thoughts of suicide and self-harm. There have also been 84 cases where patients have taken their own lives, but the MHRA points out the reports are not proof the drug caused these problems.

It also said such stories from patients and their families were enough of a concern to usher in the new measures, however.

One youngster whose tragic death has been linked to the drug was 18-year-old Melissa Martin-Hughes, who was found hanged in 2010 after she spiralled into depression because of severe acne. She had been prescribed isotretinoin and the contraceptive pill to help improve her skin.

The powerful acne drug isotretinoin is sold under the name Roaccutane, and is taken by 48,000 people in the UK

The powerful acne drug isotretinoin is sold under the name Roaccutane, and is taken by 48,000 people in the UK

The medication was also linked to the death of 21-year-old Luke Reeves, too, died of a drug overdose in 2016. An inquest the following year was inconclusive as to whether isotretinoin had affected his mental state – but acknowledged he was not in his right mind when he died.

Roche, the drug giant who developed isotretinoin, says: ‘Millions worldwide have taken Roaccutane but, like most medications, it can have side-effects.

‘It is vital that patients are fully informed as to what to expect when they take it and that they are monitored closely to ensure they get the ongoing care they need.’

Dermatologists also point to the findings of a major review published in November as reassurance that the drug is safe.

The study looked at data from 1.6 million patients to see whether there is a link between isotretinoin and serious mental health problems. It found the risk of suicide two to four years after stopping treatment was actually lower in patients on the drug than those not prescribed it.

Dr Tony Bewley, a consultant dermatologist at Whipps Cross and Barts, explains that the risks of isotretinoin, like any drug, must be weighed up against the benefits – most importantly the well-accepted fact that severe acne itself can have a significant impact on mental health.

He says: ‘Acne is mild in many patients and will be dealt with by a course of antibiotic cream the GP can prescribe, but in severe cases it’s an inflammatory condition that causes boils and cysts on the chest and back that make sitting painful. Many patients complain of burning and itching skin.

‘There is also a great deal of stigma – people worry they’ll be judged for being dirty, unkempt or just not looking after themselves. They’re told it’s because they’ve eaten too much chocolate or fried food, which isn’t the case.

‘Often, they’ll keep their feeling of depression a secret because they worry that they’ll be seen as vain for worrying about a problem that others see as trivial.

‘The longer it goes on, the worse the risk of scarring – which is life-long – and the worse the mental health impact.

‘Dermatologists treat the severe cases that don’t respond to standard drugs and when all else has failed, isotretinoin is an option.’

But Helen Wright, 52, insists her daughter, Annabel – who took her own life aged just 15 in 2019, six months after starting a course of isotretinoin – was not depressed before she started on the drug.

Mrs Wright, from Ripon, North Yorkshire, says: ‘My daughter’s acne was mild. I questioned the dermatologist at the time because I’d heard stories about people in America.

‘She told me people took their own lives because they were depressed about their skin, not because of the drug. She said she wanted to put Annabel on it before she got any scarring and assured me it was safe. I believed her.’

She recalls that before her daughter died, she had been excited about a friend joining her on the family’s holiday to Spain and revising for upcoming exams.

Mrs Wright says she believes ‘whatever hit Annabel, hit her like a tidal wave’, adding: ‘We had no idea what had happened.’

It was soon after Annabel’s funeral that Mrs Wright and her husband, Simon, 59, discovered other young people had taken their own lives in similar circumstances.

‘A friend showed me a news article about how medical student Jon Medland had died and everything suddenly made sense.

‘Annabel wasn’t depressed, she had no problems and had been bright as a button on the night she died. She had a perfectly normal conversation with her father, then went upstairs. We later found she had messaged a friend saying “I feel down” – and that was it.’

At an inquest in 2021, the court heard that in the months before her death, Annabel had posted a photo on Snapchat captioned ‘life is not worth living’ and had self-harmed ‘but could not explain why’, according to her mother.

A coroner determined there was no evidence that isotretinoin had caused or contributed to her suicide – a verdict the Wright family has branded ‘wilfully ignorant’.

Mrs Wright says the drug is ‘dangerous’, adding: ‘Dermatologists are unwilling to give it up as isotreninoin does work. But the side effects are so bad.’

She has also accused the doctors of ‘not listening to what patients are saying’, claiming ‘that’s why what this drug is doing isn’t being properly documented’.

The main concern about the new guidance among specialists is a practical one, claim those the Mail has spoken to. ‘Some dermatologists, especially in private practice, don’t have another doctor working close by to ask to review the case in order to get the second signature,’ one source says.

‘In these cases, the patient would be sent back to the GP who referred them, as they’re permitted to sign off on the prescription – but this could take weeks.

‘The decision to change the guidance wasn’t based on any real evidence – the drug has been linked to suicide but science doesn’t support the claim. If anything, it reduces the risk.’

Not all experts are against the new checks, though. Dr Alia Ahmed, consultant dermatologist at the London Skin and Hair Clinic, says: ‘Alongside the reports from patients suffering low mood, there is evidence that isotretinoin can affect brain function. Until we understand this better, it’s difficult to say dermatologists should ignore the MHRA.

‘It can be disappointing for patients who turn up expecting a prescription. But I explain it’s for their own safety.’

But the British Association of Dermatologists says: ‘Some aspects of the regulation are new and some of these will likely prove to be very challenging to implement.

‘We are aware that parts may call into question the viability of some acne services and have a negative impact on patients. One important issue raised by acne services repeatedly is the requirement for two prescribers to approve the treatment for patients under the age of 18.

‘BAD is collecting feedback from our members to understand the most pressing issues and feed these back to the MHRA, and it is hopeful that particularly problematic areas can be resolved.’

For confidential support, call Samaritans on 116 123, or visit samaritans.org

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