Britain’s health watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), has announced a series of regulatory changes to strengthen the safe use of the drug isotretinoin – linked to suicide in the past – including more monitoring during use.
Also known by the brand names Roaccutane and Reticutan, it’s an effective treatment for severe acne or when there is a risk of permanent scarring.
Yet while the drug has helped many patients with severe acne, concerns have arisen regarding suspected mental health side effects, including depression, anxiety, psychotic symptoms, and suicide, as well as sexual side effects.
Thus, says the MRHA, among other safety measures, treatment for UK patients under 18 must now be approved by two prescribers, reports Medscape.
After an expert safety review, the Commission on Human Medicines (CHM) agreed in April to various recommendations.
The safety review concluded that because of gaps in the available evidence, it was not possible to say that isotretinoin definitely caused many of the short-term or long-term mental health and sexual side effects.
However, since the individual experiences of patients and families continued to cause concern, it was recommended that action be taken to ensure patients were made aware of these potential risks and that they were carefully monitored during treatment.
Additional safeguards on isotretinoin prescribing were recommended for patients under 18.
“The overall balance of risks and benefits for isotretinoin remains favourable,” the report authors concluded, but further action should be taken to ensure patients were fully informed about the medication, and were effectively monitored during and after treatment.
The key recommendations are that there should be better:
• Information: patients and their families should receive more thorough information about the risks of isotretinoin so they can make an informed decision before using it
• Monitoring: consistent monitoring of a patient's mental health and sexual health so any problems are spotted earlier; there should be defined routes for patients to receive help
• Checks: before first prescribing isotretinoin to young people, tighter controls should be in place so that it is only started when two doctors agree the acne is severe enough to justify it, and only if other standard treatments had not worked
• Communication: patients should receive information about the risks of isotretinoin earlier, before they have a full discussion with a specialist dermatologist, so they have more time to consider fully the benefits and risks
• Product information: healthcare professionals must counsel patients and their families on the risks of mental health and sexual side effects
• Knowledge: further research should be done on the risks of mental health and sexual side effects associated with isotretinoin
Medscape article – New MHRA Rules for Treatment With Isotretinoin (Open access)
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Call for tighter safety measures for acne drug linked to suicides
Roaccutane link to 10 suicides leads to UK drugs regulator re-opening inquiry
Cheap BP drug could treat acne – Southampton study