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Medicinal Products Availability

Dáil Éireann Debate, Wednesday - 26 June 2013

Wednesday, 26 June 2013

Questions (236)

Mary Mitchell O'Connor

Question:

236. Deputy Mary Mitchell O'Connor asked the Minister for Health the figures that are available regarding deaths attributable to the use of birth control pills here, especially brands Yaz and Yasmin which have been linked with recent deaths in Canada; if there is any record of these drugs being illegally imported into the country; and if he will make a statement on the matter. [31142/13]

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Written answers

Yasmin and Yaz are prescription-only combined oral contraceptives which are authorised for use in Ireland and across the EU since 2000 and 2008, respectively.

It is well established for many years that combined contraceptives carry a very small risk of clots, known as venous thromboembolism. Detailed information about the risk of clots is clearly outlined in the product information for healthcare professionals and patients. The Irish Medicines Board (IMB) has highlighted safety issues associated with use of combined contraceptives to healthcare professionals on many occasions, most recently in its Drug Safety Newsletter Edition 42 from June 2011. This risk has also been closely monitored across the EU over the years and has been the subject of a number of reviews. A further review is currently underway and is expected to be concluded in the coming months.

To date, the IMB has received six reports of adverse reactions associated with the use of combined oral contraceptives where the patients concerned were reported to have died due to clotting related complications. Two of these reports involved use of Yasmin and Yaz. For one of those fatalities, the patient was reported to have purchased the contraceptive online and had other risk factors that could have contraindicated the use of any oral contraceptive.

Under the Medicinal Products (Prescription and Control of Supply) Regulations, 2003, as amended, it is illegal for prescription medicines to be supplied by mail order. This includes ordering prescription medicines through internet sites. The IMB works closely with the Revenue's Customs Service and an Garda Síochána to prevent the illegal sales of prescription only medicines. This co-operation has led to the seizure of many individual packets of medicines and has resulted in a number of prosecutions and other enforcement actions involving website operators.

The IMB has consistently stressed the dangers of buying medicines online and urges consumers not to risk their health by using these illegal medicines. In cooperation with the Customs Service, the IMB follows up with the intended recipient of each of these attempted supplies and explains that the product is illegal and the health risks associated with seeking to source and use such products.

In 2012 there were no seizures of Yaz, 63 seizures of Yasmin, 63 seizures of Yasminelle and 147 seizures of Yarina (both of which are similar products to Yaz and Yasmin).

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