Risks and precautions when prescribing isotretinoin
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Risks and precautions when prescribing isotretinoin A recent Drug Safety Update from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) reminds healthcare professionals of the important risks associated with use of isotretinoin which require specialist oversight. Following concerns raised by patients or their representatives regarding the nature and severity of some adverse events, the Commission on Human Medicines (CHM) has endorsed a review by the Isotretinoin Working Group. The available evidence for the risks of psychiatric adverse events (depression, anxiety, psychotic symptoms) and sexual dysfunction (erectile dysfunction, decreased libido, vaginal dryness) will be examined, including possible persistence after drug discontinuation, and may consider other safety aspects such as suicidal thoughts. The working group will advise the CHM about the requirement for further action or to raise awareness of these risks. Healthcare professionals should monitor patients for signs of depression, and refer them for appropriate treatments. Patients should be advised to watch out for affects on their mental health, with help from family and friends, and of what actions to take if symptoms occur. Isotretinoin is contraindicated in women of childbearing potential unless they meet the conditions of the Pregnancy Prevention Programme. Medicines and Healthcare products Regulatory Agency. Isotretinoin (Roaccutane): reminder of important risks and precautions Drug Safety Update : 26 Aug 2020. Available 803500768 from: URL: https://www.gov.uk/drug-safety-update/isotretinoin-roaccutane-reminder-of-important-risks-and-precautions
0114-9954/20/1821-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
Reactions 12 Sep 2020 No. 1821
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