Michael Healy-Rae (Kerry South, Independent)
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Question 196: To ask the Minister for Health if a cancer drug, Roaccutane is safe for all persons for whom it is prescribed; and if he will make a statement on the matter. [23208/12]

Róisín Shortall (Dublin North West, Labour)
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While there are studies on the use of Roaccutane to treat certain cancers, it is only authorised in Ireland for treating severe forms of acne which have been resistant to other standard therapies. It should only be prescribed by or under the supervision of doctors with expertise in using the product and with a full understanding of the risks of therapy and the monitoring requirements.

There are some types of patients who should not be prescribed or use Roaccutane:

· women who are pregnant or breastfeeding;

· women of childbearing potential unless all of the conditions of the pregnancy prevention programme are met;

· patients with liver disease;

. patients with high levels of blood fats;

· patients with very high levels of vitamin A;

· patients being treated with medicines called tetracyclines.

The information for patients and for their doctors includes detailed advice on the risks associated with use of Roaccutane and recommendations to minimise their occurrence.

Roaccutane has been closely monitored at national and EU level since it was first authorised and its benefits and risks were reviewed at EU level in April 2011. The benefits of treatment are considered to outweigh the risks, when the product is used in accordance with the approved product information.