To: Dr June Raine MRCP CBE Chief Executive, MHRA 10 South Colonnade Canary Wharf London E14 4PU From: Dr Neil MacFarlane MRCPsych (email address held by the MHRA) 26th August 2020 (by email, & paper copy – ‘signed for’ delivery) Re: MHRA Isotretinoin Review Dear Dr Raine Many patients and relatives who have beenContinue reading “‘Pause’ of MHRA isotretinoin Review: letter to chief executive June Raine”
Author Archives: AcneAwareUK
2020 MHRA Isotretinoin Review submission: suspension of licence for under-eighteens, and a mandatory consent form for adults.
Isotretinoin has not been properly shown to be effective or safe. The Cumberlege Report of July 2020 shows that doctors and regulators have not listened to harmed patients, and even ‘gaslighted’ them, for decades. (a) Many of the Cumberlege findings and recommendations on conflicts of interest, and their disclosure, were the same as in theContinue reading “2020 MHRA Isotretinoin Review submission: suspension of licence for under-eighteens, and a mandatory consent form for adults.”
isotretinoin/Roaccutane causes depression, psychosis and suicide
After decades of case reports to regulators suggesting an increase in depression and suicide with the drug, a 2008 Canadian study (Azoulay et al) of more than 30,000 patients found that: A quantified association with both depression and suicide had previously (2001) been detected in an analysis of case reports to the United States FDAContinue reading “isotretinoin/Roaccutane causes depression, psychosis and suicide”
isotretinoin (Roaccutane) is highly toxic
(This is our first blog post) The current UK ‘Summary of Product Characteristics‘ for doctors states : ‘4.4 Special warnings and precautions for use Teratogenic effects Roaccutane is a powerful human teratogen inducing a high frequency of severe and life threatening birth defects. Roaccutane is strictly contraindicated in: – Pregnant women – Women of childbearingContinue reading “isotretinoin (Roaccutane) is highly toxic”
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