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Safety of isotretinoin to be reviewed by MHRA

An expert group of the Commission of Human Medicines is to be assembled to consider all data on the risk of psychiatric adverse reactions associated with isotretinoin (Roaccutane), according to a spokesman for the Medicines and Healthcare products Regulatory Agency. “It will also clarify how to best minimise that risk and what further research should be undertaken to achieve that. The date of this meeting has not yet been finalised but will likely [be] in the coming months,” he told The Pharmaceutical Journal.

The MHRA has kept the safety of isotretinoin under close review since it was licensed in the UK in 1983.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11138032

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