Jonathan O'Brien (Cork North Central, Sinn Fein)
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Question 39: To ask the Minister for Defence if the drug Lariam remains on the approved list of drugs given to the Defence Forces for services overseas in areas affected by Malaria in view of the controversy regarding its side effects; if other anti-malaria drugs have been approved for use; and if he will make a statement on the matter. [8523/11]

Alan Shatter (Dublin South, Fine Gael)
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Lariam is a chemo prophylactic agent first authorised for use in 1989 by the Irish Medicines Board which is the statutory body charged with regulating the use of medicines to ensure the quality, safety and efficacy of medicines available in Ireland. It remains the medication of choice for the Defence Forces for overseas missions to certain malarious areas. While certain risks associated with the use of the drug were highlighted in drug safety newsletters in 1996 and 2003, the Irish Medicines Board remained of the view that the benefit-risk profile for the product remained acceptable. The board continues to review the safety of this and all other 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 contra-indications, warnings and side effects highlighted by the Irish Medicines Board - the Defence Forces screen all personnel for medical suitability. The screening system rules out from overseas service personnel with certain conditions such as, for example, depression, anxiety, neurodegenerative disorders, etc., which, as has been indicated by the Irish Medicines 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 Medical Board guidelines. This typically involves review of the individual's previous experience, if any, with the medication. His or her 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 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 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 found not medically suitable for the mission.

Additional information not given on the floor of the House.

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 those with contra-indications to Lariam use are deemed unsuitable for overseas service and not prescribed the medication.

There are three other anti-malaria 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 which I will now set out. Chloroquine is no longer in use because of the development of widespread resistance. Doxycycline has to be taken in the absence of dairy products and can produce sun-sensitivity skin rashes in some individuals. This is particularly significant when used in very sunny climes. 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 by the Irish Medicines Board for no more than 28 days continuous use in a malarious area. In this context, this prophylactic agent is only suitable for use where the overseas deployment does not exceed 28 days.

These are among the reasons Lariam remains the anti-malaria chemoprophylactic agent of choice in areas where the predominant species of malaria is the virulent Plasmodium Falciparum. Lariam, therefore, is the agent of first choice on any sub-Saharan missions undertaken by the Defence Forces. On the other hand, Doxycycline is the anti-malaria chemoprophylactic agent of choice in Afghanistan where the predominant species of malaria is the less virulent Plasmodium Vivax.

Jonathan O'Brien (Cork North Central, Sinn Fein)
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Is the Minister aware that a number of reports have been made to the Irish Medicines Board on the use of this drug? Has his Department been given notice of possible compensation claims resulting from its use? He has said Defence Forces personnel are medically tested before serving abroad. However, there is no medical testing of personnel on their return. Since February 2009, the United States army no longer lists Lariam as the preferred anti-malaria drug. It now uses an alternative. Is Lariam used because it is the cheapest anti-malaria drug on the market? Is this why we continue to use it despite warnings about its safety?

Alan Shatter (Dublin South, Fine Gael)
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The reason we use the drug is not it is the cheapest on the market. Three other anti-malaria medications are available: Chloroquine, Malarone and Doxycycline. However, there are specific reasons each of these products is not suitable for use by the Defence Forces in sub-Saharan Africa, the area in which the drug has been used. Chloroquine is no longer in use because of the development of widespread resistance. Doxycycline has to be taken in the absence of dairy products and 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 by the Irish Medicines Board for no more than 28 days continuous use in a malarious area. Therefore, this prophylactic agent is only suitable for use when the overseas deployment does not exceed 28 days.

With regard to the extent of problems resulting from the use of Lariam, there are three members of the Defence Forces with serious symptomatology which may have been caused or contributed to by Lariam, although there is nothing conclusive in this regard. I am also advised by the military authorities that all three personnel have made a full recovery and that their cases have been reported to the Irish Medicines Board. In addition, I understand there is a further cohort of seven personnel with less dramatic symptomatology who remain under review. Again, there is no conclusive evidence that the use of Lariam was a factor in any of these cases.

I understand the United States defence forces stopped using the medication owing to concern about inadvertent prescribing of the drug to soldiers who should not take it. The United States defence forces did not carry out an assessment in advance of soldiers using Lariam of the contra-indications of use or whether its use was appropriate. Instead, the US authorities undertook mass administration of a drug, Lariam, which is, essentially, for soldiers serving in areas subject to malaria. The US defence forces have ceased using the drug. They are now using another drug, one of the ones the Irish Medicines Board has passed and to which I made reference but which is only recommended in this state for use by the Defence Forces continuously for no longer than 28 days.

Jonathan O'Brien (Cork North Central, Sinn Fein)
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Will the Minister continue to monitor the use of Lariam? He has said the US army no longer uses it. There is a reason for this. A number of US personnel reported side effects, as has happened in this state. Does the Minister know of any suicides by people who had taken this medicine?

Alan Shatter (Dublin South, Fine Gael)
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I am unaware of a suicide by any member of the Defence Forces linked to this medicine. The US defence forces stopped using Lariam because they had not undertaken medical examinations to ascertain whether there were contra-indications, as are undertaken in this state before soldiers are posted abroad on UN missions. The US defence forces mass-prescribed it without undertaking any checks. That gave rise to particular problems in the way they dealt with the matter. There are substantial numbers of deaths from malaria every year in areas subject to it. The prescribing of this drug provides members of the Defence Forces with protection against malaria that is crucial if they are to engage in peacekeeping missions in areas where malaria is prevalent. It is the job of the Irish Medicines Board to keep any drugs prescribed in any circumstances in the State under review, including those made available to the Defence Forces for any purpose. I presume it will keep Lariam under review, as it has been doing up to now.