Brian O'Shea (Waterford, Labour)
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Question 2: To ask the Minister for Defence the number of Defence Forces personnel who have been diagnosed as suffering from Lariam Toxicity in each of the past five years and to date in 2010; and if he will make a statement on the matter. [38260/10]

Tony Killeen (Clare, Fianna Fail)
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Lariam is authorised for use by the Irish Medicines Board which is the statutory regulatory body charged with regulating the use of medicines, to ensure the quality, safety and efficacy of medicines available in Ireland. Lariam was first authorised for use by the Irish Medicines Board in 1989. The authorised product information provides details to ensure the safe and effective use of this medicinal product. While certain risks associated with the use of the drug were highlighted in Drug Safety Newsletter in 1996 and 2003, the Irish Medicines Board remained of the view that the benefit-risk profile for the product remained acceptable. The IMB continues to review the safety of this and all medicines on an ongoing basis and updates the product information as appropriate.

In accordance with best practice in prescribing this medication and taking account of the contraindications, warnings and side effects highlighted by the IMB, the Defence Forces screen all personnel for medical suitability. The screening system automatically rules out from overseas service personnel with certain conditions, for example depression, anxiety, neurodegenerative disorders etc. which, as has been indicated by the Irish Medicine Board, are more likely to precipitate serious adverse reactions to Lariam. Pregnant personnel are also excluded.

In the case of overseas missions to malarious areas, the medical screening involves an assessment of the individual's suitability to be prescribed the selected anti-malarial agent in line with current Irish Medicines Board guidelines. This typically involves review of the individual's previous experience, if any, with the medication. The individual's medical history is also screened for those conditions, which have been identified as precipitating serious side effects in association with the medication. In addition, blood tests are carried out to ensure that the liver is healthy as liver disease is an accepted contraindication to the use of Lariam.

It is the policy of the Defence Forces medical corps that personnel who are found suitable for Lariam should commence their medication three to four weeks in advance of their travel. The purpose of this precaution is twofold. While it allows a slow build up of the medication in the bloodstream, it also permits assessment by the person of his or her individual reaction to the medication while still in Ireland. During this probationary period the individual can consult with a medical officer over any adverse reaction, minor or major. Some minor reactions may be transient but if persistent or troublesome, the individual will be deemed to have sensitivity to the medication and will be found not medically suitable for the mission.

There are three other anti-malarial medications available, Chloroquine, Malarone and Doxycycline. However, in the case of each of these products there are specific reasons they are not suitable for use by the Defence Forces in sub-Saharan Africa and I will now set these out. Chloroquine is no longer in use because of the development of widespread resistance to it. Doxycycline must be taken in the absence of dairy products and it can produce sun-sensitivity skin rashes in some individuals. This is particularly significant when used in very sunny climates. For this reason it is not recommended for first-line use by the Defence Forces in sub-Saharan Africa. Malarone is unsuitable for use as it is licensed for no more than 28 days continuous use in a malarious area by the Irish Medicines Board. In this context, this prophylactic agent is only suitable for use where the overseas deployment does not exceed 28 days.

Defence Forces medical records are mainly manually based at this time and the medical module of the personnel management system does not currently provide a diagnostic breakdown of the clinical status among the Defence Forces. As such, there is no way of providing the specific information sought by the Deputy without examining every medical record of every recipient of Lariam. Even then this would not include those who opted not to seek medical corps medical officer advice. However, the Defence Forces have advised me that as of August 2010, three members of the Defence Forces had been treated for serious symptoms which may have been caused or contributed to by Lariam, although there is nothing conclusive in this regard. I am advised by the military authorities that all these personnel have made a full recovery, and that their cases have been reported to the Irish Medicines Board. In addition, there is a further cohort of seven personnel with less dramatic symptoms, and these remain under review. Again there is no conclusive evidence that the use of Lariam was a factor in any of these cases.

The Defence Forces take all necessary precautions in assessing the suitability of personnel before prescribing Lariam, in accordance with the prescribing instructions and information provided by the Irish Medicines Board. Personnel are screened both before and after deployments and all necessary actions are taken to ensure that those with contraindications to Lariam use are deemed unsuitable for overseas service and are not prescribed the medication.

Brian O'Shea (Waterford, Labour)
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I tabled this question following a meeting I attended recently with some former members of the Defence Forces and others who are concerned about this subject. A female attending that meeting asked if Lariam can affect fertility in some cases. The Minister mentioned that a blood test is carried out in advance. What exactly does it test? An allegation was made that the reason Lariam is used is because is cheaper than other drugs. Will the Minister advise on that? Are the serving members advised of the side effects of Lariam before they take it? The Minister said three people had serious side effects from having taken it and seven others had less dramatic side affects. The number of people who had side effects to the medication appears to be very small. From what was stated at that meeting, the bottom line is that more than that number have had serious side effects from taking this medication.

Is the Minister satisfied there is sufficient tracking of people who have had side effects from the taking of Lariam as they continue to serve or on leaving the armed forces? I understand the side effects from having taken a relatively small dose of Lariam can be experienced for quite a long time. In respect of the people who had serious side effects, the Minister said that those people are now clear of all symptoms. Is he satisfied that the tracking done in respect of those people is sufficiently strong for such a categorical statement to be made about them?

Tony Killeen (Clare, Fianna Fail)
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The issue of the medication affecting fertility has not been brought to my notice at any point. I can have that matter checked for the Deputy. I understand that the blood test is carried out in the main to establish whether there would be any impacts of side effects from the potential effects of Lariam on the liver.

With regard to the prescribing of the medication, all personnel departing on a particular mission have the precautions relating to the use of Lariam, which I outlined in the initial part of my reply, applied to them. In other words, for three or four weeks before they leave, they are in receipt of this treatment and if they have any side effects in that period, they are either assessed in terms of they being relatively minor or assessed as being of such size that the person is deemed unfit to travel. That is the first level. I understand that on return personnel are also tested in that respect. It should also be noted that Lariam was approved first in 1989, and in 1996 and 2003 the Irish Medicines Board issued some additional information and advice on its use.

Brian O'Shea (Waterford, Labour)
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What is the Minister's response to the fact that the US army ceased using Lariam in February 2009?

Tony Killeen (Clare, Fianna Fail)
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I am aware of the fact that the US army has ceased using Lariam. I understand there may be two reasons for that. The first is that many of its soldiers may not be operating in areas where there is a risk of contracting malaria. My understanding is that the vast majority of armies which are deployed in sub-Saharan Africa in particular and in areas where the risk of contracting malaria from mosquito bites is very high continue to use Lariam mainly because it is at this point the drug that is most suitable for long-term use. One of the other drugs I mentioned has very severe side effects which come into play very strongly in sub-Saharan Africa. Another drug is only suitable and approved for continuous use of up to 28 days which, in the case of the vast majority of personnel on our missions, is far shorter than the four or six months stint for which people are deployed. When one goes through all the evidence it transpires that in terms of meeting all the requirements that Lariam is the only suitable drug available at this stage for our personnel.