Michael Healy-Rae (Kerry South, Independent)
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177. To ask the Minister for Health his views on the continued availability of a drug (details supplied); and if he will make a statement on the matter. [2003/15]

Kathleen Lynch (Cork North Central, Labour)
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Roaccutane (containing the active substance, isotretinoin) is authorised in Ireland and the EU for treating severe forms of acne which have been resistant to other standard therapies.

The guidance to support appropriate use and monitoring of Roaccutane is based on assessment of the currently available data, which changes over time, as new information is generated on an on-going basis from a variety of sources, including post marketing experience, further studies, literature reviews, etc. The current product information reflects these recommendations.

Roaccutane should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements. The requirements for specific monitoring of the patient are described in detail in the Summary of Product Characteristics (SPC) in relation to psychiatric disorders, severe skin reactions, allergic reactions, liver enzymes, serum lipids and the pregnancy prevention programme. Monitoring in these circumstances is through ongoing review of the patient by the prescribing doctor, as part of their clinical practice.

Roaccutane has not been banned from any markets for regulatory reasons. It is understood that Roche Pharmaceuticals, the manufacturer of Roaccutane, has discontinued marketing in some countries, including the US, for commercial reasons. Generic forms of isotretinoin continue to be available in these countries.