Pat Gallagher (Donegal South West, Fianna Fail)

Ar an gcéad dul síos, ba mhaith liom mo bhuíochas a chuir in iúl don Seanadóir Deirdre de Búrca as ucht na ceiste seo a ardú ar an Athló agus deis a thabhairt dom freagra a thabhairt ar son an Aire Sláinte agus Leanaí, an Teachta Harney.

Depo-Provera is a contraceptive administered intramuscularly. It has been authorised as a contraceptive medicinal product in Ireland since 1996. It is known to affect bone mineral density in women of all ages. Data suggest bone mineral density recovers when Depo-Provera is stopped, although the rate of recovery is dependent on the duration of use. The effect on adolescents may be more significant than on adults due to the fact that bone mineral density is normally increasing at that age.

The Irish Medicines Board, the body responsible for licensing medicinal products, considers that the overall benefit-risk profile for Depo-Provera is favourable in the context of its recommended use. The board will continue to review the safety information on Depo-Provera and all other medicinal products authorised for use in Ireland and take appropriate regulatory action, as necessary. Benefit and risk assessment for specific patients must be considered on an individual basis, taking into account any relevant medical history or risk factors.

In the United States a black box or black label warning is a warning that appears on prescription drugs that may cause serious adverse effects. It is so named because of the black border that usually surrounds the text of the warning. Black box warnings are used in the United States but not in Ireland. Instead, all safety warnings are printed on the patient information leaflet that accompanies the product. It should be noted that safety warnings contained in the product's information leaflet are essentially the same as the black box warning issued by the US Food and Drug Administration. The same outcome is achieved, although the format used is different.

There are side effects associated with Depo-Provera, as there are with all contraceptive medicines and all medicines. However, medical practitioners have information available to them on these side effects when prescribing. Similarly, patients are advised to read the patient information leaflet. In these circumstances, I am satisfied that adequate arrangements are in place to monitor the safety of this product on an ongoing basis, particularly having regard to the role of the Irish Medicines Board.