Clare Daly (Dublin North, United Left)
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137. To ask the Minister for Defence if he is aware of any under-reporting to the Health Products Regulatory Authority of the suspected adverse effects of the use of Lariam by members of the Defence Forces; and if he will make a statement on the matter. [21354/15]

Simon Coveney (Cork South Central, Fine Gael)
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As the Deputy will be aware, the Health Products Regulatory Authority (HPRA) formerly the Irish Medicines Board is the statutory authority with responsibility for the quality, safety and efficacy of medicines in Ireland. The Defence Forces policy in regard to the prescribing of Lariam is in line with current HPRA guidelines.

While there is no mandatory legal requirement on an individual or medical practitioner to report adverse reactions to any medication, it is open to anyone to report issues relating to safety and quality of healthcare products to the HPRA. This includes patients, carers, other members of the public and healthcare professionals. I can confirm that individual Defence Forces Medical Officers have reported adverse reactions to the HPRA in accordance with standard practice. I understand, based on the latest information that there were 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 advised by the military authorities that all three of them have made a full recovery and that their cases were reported to the HPRA. Again there is no conclusive evidence that the use of Lariam was a factor in any of these cases.

The HPRA has informed me that to date it has received a total of one hundred and thirteen adverse drug reaction reports relating to the use of Lariam. Of those, I am advised that thirty six reports appear to be associated with current or ex-members of the Defence Forces. However the HPRA advises that these figures are open to an element of duplication due to incomplete material and the manner in which reports are made.

Given that reports can be made directly to the HPRA by individual members of the Defence Forces or health care professionals, I am not aware as to whether any under reporting of suspected adverse effects of Lariam by the Defence Forces members occurs. It should also be noted that the occurrence of an adverse reaction may not always be attributable to a particular medication and may be attributable to other causes.

It is the policy of the Defence Forces that personnel are individually screened for fitness for service overseas and medical suitability, i.e. a medical risk assessment for Lariam is carried out on an individual basis.

Former Ministers for Defence have had the various concerns surrounding the use of Lariam investigated thoroughly and obtained the advice of leading medical experts, who concur with the prescribing practices followed by the Defence Forces.

Lariam must remain in the formulary of medications prescribed by the Medical Corps for Defence Forces personnel on appropriate overseas missions, particularly those in sub-Saharan Africa, to ensure that our military personnel can have the most effective protection from the very serious risks posed by this highly dangerous disease.