Dáil Éireann Debate, Tuesday - 4 April 2017
550. Deputy Michael Healy-Rae asked the Minister for Health if the HPRA has a report of Roaccutane being used for its intended purpose, which is cancer; and if he will make a statement on the matter. [16624/17]
Amharc ar fhreagra556. Deputy Michael Healy-Rae asked the Minister for Health the number of persons who were dispensed Roaccutane as per HSE records each year from 2005 to 2016 and to date in 2017; and if he will make a statement on the matter. [16656/17]
Amharc ar fhreagra558. Deputy Michael Healy-Rae asked the Minister for Health the law under which a cancer drug, namely, Roaccutane, is permitted to be prescribed, sold and used without full information; and if he will make a statement on the matter. [16664/17]
Amharc ar fhreagra569. Deputy Michael Healy-Rae asked the Minister for Health the reason Roaccutane is still available here (details supplied); and if he will make a statement on the matter. [16764/17]
Amharc ar fhreagra570. Deputy Michael Healy-Rae asked the Minister for Health if the HPRA has information on Roaccutane being used for its intended purpose of cancer treatment; and if he will make a statement on the matter. [16765/17]
Amharc ar fhreagra571. Deputy Michael Healy-Rae asked the Minister for Health his views on the use of Roaccutane, a chemotherapy drug, for a benign condition such as acne; and if he will make a statement on the matter. [16766/17]
Amharc ar fhreagra572. Deputy Michael Healy-Rae asked the Minister for Health the number of legal cases in respect of Roaccutane in process; the number of cases which have taken place here since 1983; and if the HPRA was or is involved; and if he will make a statement on the matter. [16767/17]
Amharc ar fhreagraI propose to take Questions Nos. 550, 556, 558, 569 to 572, inclusive, together.
As previously stated to the Deputy, 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. It is not at present (nor was it ever) authorised in Ireland for the treatment of cancer.
As with all licensed medicinal products in Ireland, product information for Roaccutane is available to patients and healthcare professionals. The product information is comprised of the Summary of Product Characteristics (SmPC), mainly for the doctor and the Package Leaflet for the patient. These documents are issued when a medicinal product is first authorised for use, and are reviewed and updated as necessary to reflect the current state of knowledge of the medicinal product and the risks associated with its use. Both are available on the HPRA website.
Roaccutane is authorised as a prescription only medicine, subject to the Medicinal Products (Prescription and Control of Supply) Regulations. The requirements for specific monitoring of the patient are described in detail in the SmPC 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. Educational materials to support safe and appropriate use of Roaccutane by healthcare professionals and patients have also been approved by the HPRA and are accessible from its website.
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 of global adverse reaction data, further studies, literature reviews, etc.
Assessments are carried out on an ongoing basis by EU regulatory authorities to determine if the benefits of a particular medicine continue to outweigh the potential risks and to consider if steps need to be taken, such as updates to the product information, to further highlight/minimise the risks. A review of all retinoid-containing medicines, including Roaccutane is currently underway at EU level, considering the measures currently in place for pregnancy prevention, as well as warnings and recommendations in the product information related to depression, anxiety and suicidal behaviour.
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.
Since 2000, there have been eleven cases brought with respect to Roaccutane® to which the HPRA/IMB was named as co-defendant. Requests for information on total number of legal cases in relation to Roaccutane® referred to by the Deputy should be addressed directly to the pharmaceutical company concerned.
As to the number of people that were dispensed Roaccutane, this matter has been referred to the HSE for attention and direct reply to you. If you have not received a reply from the HSE within 10 working days, please contact my Private Office and they will follow up the matter with them.
