madman
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Isotretinoin: Regulator adds prescribing safeguards after review of side effects
Two prescribers, including a dermatology specialist, must now sign off new prescriptions of the acne medicine isotretinoin (brand names include Roaccutane and Reticutan) for patients aged under 18,1 after concerns were raised over potential sexual and mental health side effects, including...
Elisabeth Mahase
Two prescribers, including a dermatology specialist, must now sign off new prescriptions of the acne medicine isotretinoin (brand names include Roaccutane and Reticutan) for patients aged under 18,1 after concerns were raised over potential sexual and mental health side effects, including suicide.2
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) carried out a safety review of all the available evidence, including information provided by patients and their families, and concluded that evidence gaps meant that it was not possible to say that isotretinoin had caused short or long term psychiatric and sexual side effects.
However, it emphasized that “individual experiences of patients and families continue to cause concern.”As a result, the regulator has introduced additional safeguards to be observed when prescribing isotretinoin to patients under 18, including the two independent assessments and all patients being made aware of the potential risks, alongside closer monitoring of mental health and sexual wellbeing during treatment.
Isotretinoin is used to treat severe acne in patients when other treatments have not worked. It should not be prescribed in children under 12 or before puberty.
Alison Cave, MHRA chief safety officer, said, “Like all medicines, isotretinoin may be associated with potential side effects. For isotretinoin, there may be possible impacts on mental health and sexual function. While not every patient will experience them, the new measures will ensure that patients are well informed, that they are carefully monitored throughout treatment, and that there is additional oversight on isotretinoin prescribing for patients under 18.
”The MHRA has said that the product information for the acne treatments will now be updated to list potential sexual side effects and to mention that healthcare professionals must counsel patients and their families on the risk of psychiatric and sexual side effects.
“Patients and their families must have sufficient time to consider this information and be able to ask questions before starting treatment,” the regulator advised, adding that patients who choose to go ahead with the treatment must be monitored throughout their course.
