Parliamentary Question | safety assessments of Roaccutane | 21 January 2013

January 22, 2013

Kerry MCarthy, Labour MP for Bristol East, tabled a question for the Secretary of State for Health that asked whether his Department has made any comparative assessment of the safety assessments made by the (a) US and (b) EU authorities in respect of the drug Roaccutane; and what representations he has received on its availability for prescription in the UK.

In his written answer on 21 January 13, the Coalition's Minister of State for Care and Support Norman Lamb (Lib Dem) replied:

As for all medicines on the United Kingdom market, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps the safety of Roaccutane and all medicines containing isotretinoin under continuous review. As the reference member state for Roaccutane, the MHRA leads the European safety assessment, in which the views of EU authorities are included.

Although no direct comparison with US safety assessments of Roaccutane has been undertaken, the marketing authorisation holders for isotretinoin-containing medicines are required to submit all worldwide safety data including adverse reactions suspected to be associated with isotretinoin, published literature and studies, and to keep MHRA informed of any safety decisions made in other countries.

In the UK, Roaccutane and other isotretinoin-containing medicines are only available on prescription from a doctor and the licensing terms mean that isotretinoin can only be prescribed by or under the supervision of a consultant dermatologist. This information has been communicated to healthcare professionals by the MHRA and is reflected in the clinical guidelines issued by the British Association of Dermatologists.

A search of the Department's ministerial correspondence database has not identified any correspondence or parliamentary questions received since 1 May 2012, about the availability of Roaccutane for prescription in the UK. This is a minimum figure, which represents correspondence received by the Department's ministerial correspondence unit only.

MEA note: Members of the MEA recently discussed the use of Roaccutane in the treatment of persistent acne in several recent issues of our membership magazine. At the time, our medical adviser, Dr Charles Shepherd, commented: “Roaccutane is sometimes used for more severe cases that have not responded to any other form of treatment. This is a drug that has a considerable range potential side-effects, including psychiatric ones, and a number that overlap with ME/CFS symptomatology (eg headaches, muscle pain, fatigue,). Some of these side-effects can be serious, which is why the drug should only be prescribed by a consultant skin specialist. So it would need to be used with care in someone with ME/CFS.”

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