MHRA to review acne treatment isotretinoin and suspected links with psychiatric and sexual side effects

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The Medicines and Healthcare products Regulatory Agency (MHRA) has  issued a call for information on isotretinoin, a treatment for severe acne, which has been linked with psychiatric and sexual side effects.

This information is to be considered as part of an expert review of isotretinoin being conducted by MHRA, with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group (IEWG). Patients and their families, healthcare professionals, researchers and organisations are being invited to contribute to the review, and although it is focused on the UK, contributions from outside of the UK are also welcomed. The MHRA is particularly interested in possible benefits and risks of isotretinoin treatment, the measures currently in place to minimise the risks and whether additional measures are needed to optimise its safe use.

Isotretinoin, also known in the UK by the brand names Roaccutane, Reticutan and Rizuderm, is an effective medicine for severe forms of acne that have not responded to antibiotics and treatments such as creams and gels. As with all medicines, there are suspected side effects, some of which can be severe, and isotretinoin should only be prescribed under the supervision of consultant dermatologists.

Dr Sarah Branch, Director of Vigilance and Risk Management of Medicines at the MHRA, said: “We want patients taking isotretinoin to be informed of the risks and benefits and have recently issued a reminder to healthcare professionals.

“All medicines can cause side effects, and we need to ensure that the benefits of taking isotretinoin outweigh the potential risks associated with this medicine. That is why we need people’s help to gather information on psychiatric or sexual disorders, that they have suffered, and suspect to be associated with isotretinoin treatment.

“We are asking patients, family members and healthcare professionals to contribute to the review so that the Expert Working Group has-up-to-date information to consider. All information we receive will be treated confidentially.

“We know this is a personal issue for anyone who suspects they have suffered psychiatric or sexual disorders with isotretinoin treatment; therefore, we would appreciate any help you may be able to give us.”

All information provided through this call will be reviewed by the IEWG, an independent group of medical and scientific experts, as well as lay representatives and observers from relevant clinical organisations. The IEWG will report to the Commission on Human Medicines who will review the final recommendations. The Expert Working Group will also advise whether the MHRA should take additional action, such as improving the information on isotretinoin available to patients, to help minimise the risks of potential serious side effects.

Any queries regarding the review or the call for information should email or phone 020 3080 6000.

This consultation closes at 11:59pm on 2 February 2021. Responses can be provided using this secure online form.

Anyone in the UK who suspects they may have experienced a side effect with isotretinoin, or any other medicine, can submit a report to the Yellow Card Scheme. This helps makes medicines safer for everyone.

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