BETTER information about serious risks to young patients taking the acne medication isotretinoin are necessary so that patients can make informed decisions before use.
This is a key conclusion of a report from the Commission on Human Medicines.
Isotretinoin is known to be effective for severe acne unresponsive to standard treatments but there have been concerns over possible side effects, such as depression, aggressive tendencies, sexual dysfunction, psychotic disorder and suicide.
The report calls for tighter controls on prescribing isotretinoin to young people (aged 12 to 18) so that it is only used in severe acne and when other standard treatments have not worked.
It also calls for more consistent monitoring of the psychiatric and sexual health of patients taking isotretinoin so that problems can be spotted early, with defined routes for patients to receive help.
The report recommends that patients should be given information about isotretinoin before they have a full discussion with a specialist dermatologist, to allow more time to fully consider the benefits and risks. All healthcare professionals involved in the care of patients should keep each other informed about any suspected side effects.
The British Association of Dermatologists commented: “The Commission on Human Medicines (CHM) has reviewed the available evidence and reached the conclusion that the overall balance of risks and benefits for isotretinoin is favourable as long as patients have all the information they need to make an informed decision and are effectively monitored during and after treatment.
“This best practice is already established in many areas, and we welcome the opportunity to provide greater clarity for patients and healthcare professionals regarding what is expected during isotretinoin prescribing.
“We are currently working with the MHRA on specific details of how to implement the recommendations as efficiently as possible. This will ensure patients with severe acne, not responding to other treatments, can make an informed decision and can continue to access isotretinoin without unnecessary barriers.”
This page was correct at the time of publication. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.
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