Déirdre de Búrca (Green Party)
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The subject of my Adjournment matter is to ask the Minister for Health and Children to review the permission given for the use of a drug called Depo Provera. It is a long-term reproductive controlling substance. It is an injectable contraceptive that is injected into the arm or buttocks four times annually. It has been approved by the Irish Medicines Board despite the fact that it has received a black box warning by the US Food and Drink Administration.

My colleague, Deputy Gogarty, tabled a parliamentary question to the Minister who responded by stating that any concerns the Deputy had about the health or side effects of the drug should be forwarded to the Irish Medicines Board. The Minister should direct or at least request the Irish Medicines Board to re-examine the drug given the growing body of evidence from international research into the significant and potentially threatening side effects of the drug that would appear to outweigh any potential benefits that might be yielded by it.

The drug was initially promoted on the basis that it would be a preventative measure against endometrical cancer. It took many years for it to receive approval from the federal drug administration in the US. Its original manufacturers, Pharmacia and Upjohn, persistently lobbied the US federal drug administration for it to be approved as a method of birth control. While the lobbying was taking place for approval of the drug in the US, Canada and Europe, this same drug was being exported to many developing world countries as a part of population control programmes in those countries. It was not approved until 1992 in the US. Unfortunately, the information on the basis of which these approvals were made was never made public.

A growing body of international research points to the worrying side effects of the use of this substance. Some of the side effects that have been mentioned are an increase in the incidence of sexually transmitted diseases such as chlamydia and gonorrhea among young women who have been using this drug as compared to those using other forms of contraception or control groups who have not been using any form of contraception. A growing body of research also connects the use of Depo Provera to breast cancer and osteoporosis and several convincing studies show that the loss of bone mass density occurs in women who have been using the drug over a period. There have been no serious longitudinal studies of women who have used it over an extended period but it would be a matter of extreme concern if this drug was to lead to osteoporosis. In the light of serious concerns about its effects, I ask the Minister for Health and Children to contact the Irish Medicines Board to ask it to review the permission given to use this drug. This is based on reasonable concern which the board should take seriously.

Pat Gallagher (Donegal South West, Fianna Fail)
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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.