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The review of the safety of isotretinoin has concluded.
New measures strengthen the safe use of the acne drug isotretinoin for patients across the UK, following a patient-focused expert review
We have strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health and sexual function issues. We ask healthcare...
Following an expert safety review of isotretinoin, the Commission on Human Medicines has agreed to a number of recommendations to strengthen the safe use of the treatment.
Check what you need to do to sell cosmetic products in Great Britain.
Report of Isotretinoin Implementation Advisory Expert Working Group regarding recommendations to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan.
We are reviewing the risks and benefits of the acne medicine, isotretinoin. In particular whether some of the possible psychiatric and sexual side effects continue after treatment has been stopped.
The MHRA has today announced that 2 Acnecide products will be formally reclassified from pharmacy to general sale list medicines.
The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring requirements for psychiatric side effects, the introduction of new monitoring...
We remind healthcare professionals that isotretinoin should only be used for severe forms of acne resistant to adequate courses of standard therapy with systemic antibacterials and topical therapy. Prescription of isotretinoin should be supervised by specialist dermatologists with a full...
The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. All oral retinoids have an associated Pregnancy Prevention Programme (PPP), which is supported by educational...
Updated prescribing advice provided.
Cases of sexual dysfunction, predominantly involving erectile dysfunction and decreased libido, have been reported rarely in patients taking oral isotretinoin for severe acne.
New prescriber checklists, patient reminder cards, and pharmacy checklists are available to support the Pregnancy Prevention Programme in women taking acitretin, alitretinoin, and isotretinoin. Advice about the risk of neuropsychiatric reactions has been made consistent for all oral retinoid medicines.
Employment Tribunal decision.
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