Expert working group to re-examine safety of drug used by about 30,000 people a year
Fri 27 Dec 2019 08.00 GMT
Ten of 12 recorded deaths by Roaccutane users in 2019 were suicide. Photograph: BSIP/UIG/Getty Images/Universal Images Group
Ten suicides this year have been linked to a powerful acne drug as the medicines regulator reopens an inquiry into it after being contacted by patients.
Twelve deaths were recorded in 2019, 10 by suicide, by people who had been prescribed Roaccutane, according to data from the Medicines and Healthcare Products Regulatory Agency (MHRA).
The figure is up from five fatalities the year before and is the highest since records began in 1983. However, the MHRA noted that the reaction may not have occurred that year but only been reported then.
This year, Channel 4 reported about the death of Annabel Wright, with her parents Helen and Simon blaming the drug for her death, although the exact cause is yet to be confirmed.
In 2017, the parents of Luke Reeves said they believed their son’s death was linked to Roaccutane. A coroner ruled that Luke, who was found dead in his bedroom, killed himself by taking a drugs overdose in April 2017.
Robert Reeves, 50, told the hearing at Essex coroner’s court that Luke’s personality had completely changed.
In October 2012, Jack Bowlby took his life, aged 16. His parents expressed the same concerns as those of Luke Reeves. At the coroner’s inquest, one expert speculated that Jack would still be alive if he had not taken the drug.
Roaccutane, a brand name of the drug isotretinoin, is used by about 30,000 people in the UK each year. Data from NHS Digital shows prescriptions for isotretinoin rose from 34,283 to 69,040 between 2008 and 2018.
Also manufactured under the name Accutane, the drug is often credited with yielding miraculous results at clearing people’s skin.
While studies have not found a clear or direct link with increased risk of psychiatric disorders and suicide, side-effects have been noted.
Data from the MHRA’s yellow card reporting scheme – a website for reporting adverse drug reactions – recorded 12 fatalities in 2019, 85 serious incidents and 19 non-serious ones. Since records began there have been 88 deaths.
“We were never told that these random suicide impulses can come out of the blue and be overwhelming,” Helen Wright said.
In 1998, warnings about depression and other psychiatric side-effects were added to the drug’s patient information leaflet. In section four it states that “some people have had thoughts about hurting themselves or ending their own lives (suicidal thoughts), have tried to end their own lives (attempted suicide), or have ended their lives (suicide). These people may not appear to be depressed.”
Two years ago, a new warning was added to say some people would be affected by problems getting or maintaining an erection and by lower libido.
The MHRA governs the safety of the drug. It said its reporting system was “not proof of a side-effect occurring, but a suspicion by the reporter that the drug may have been the cause”.
It said the safety of isotretinoin was kept under continuous review in the UK and across Europe. The Isotretinoin Expert Working Group is being reconvened and will consider all of the available data regarding the risk of suicide, considering whether further regulatory action is needed.
The National Institute for Health and Care Excellence (Nice) plans to publish guidance on all acne treatments by 2021 and said it always considers the safety of drugs in its guidelines.
In its guidance about the options available for acne treatment, the NHS says the drug is only recommended for severe cases that have not responded to other treatments.
The NHS acknowledges there have been reports of people experiencing mood changes while taking the drug. Its advice says, while there is no evidence these changes were caused by Roaccutane, patients should speak to their doctor immediately if they feel depressed, anxious or have suicidal thoughts.
A survivors’ group linked to the drug and its side-effects on Facebook has more than 8,000 members.
In 2004, the Guardian reported that a promising medical student killed himself four weeks after being prescribed the acne drug. Jon Medland, 22, was in the final year of his medical degree at Manchester University when he killed himself at his student lodgings early on 13 January this year.
Roche said millions of patients take isotretinoin, but “like most medications, it can have side-effects”.
“That is why we recommend it is prescribed carefully, with particular consideration regarding any previous history of depression, that patients understand what to expect when they take it and that they are monitored closely to ensure they get the care they need.”