Asked by: Baroness Corston (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government what assessment they have made of the warning issued by Roche, the manufacturer of Lariam (mefloquine), in October 2013 that the drug "may induce potentially serious neuropsychiatric disorders".
Answered by Lord Prior of Brampton
Lariam (mefloquine), is an extremely effective antimalarial and is one of a number of antimalarials for travellers currently recommended by the Advisory Committee on Malaria Prevention (ACMP), an expert advisory committee of Public Health England (PHE) established in 1998 to formulate evidence-based guidelines on malaria prevention in the United Kingdom.
The use of mefloquine, for travellers, including military personnel, to high risk areas should be based on an individual risk assessment that takes into consideration the destination of travel, planned activities while travelling and the individual’s current health and medical history.
The ACMP regularly reviews data on safety and efficacy of all antimalarials. Whenever new evidence about antimalarials appears the ACMP considers this as part of its continuous process of developing advice.
The ACMP will be meeting in summer 2015 to finalise the 2015 revision of the ACMP guidelines. This meeting will review current evidence on the use of mefloquine, including data provided by Roche, and recommendations made by other countries including the United States with regard to the use of mefloquine for malaria prevention.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government what advice they have received from Public Health England on Lariam (mefloquine), in particular in relation to members of the armed forces serving in Afghanistan.
Answered by Lord Prior of Brampton
Lariam (mefloquine), is an extremely effective antimalarial and is one of a number of antimalarials for travellers currently recommended by the Advisory Committee on Malaria Prevention (ACMP), an expert advisory committee of Public Health England (PHE) established in 1998 to formulate evidence-based guidelines on malaria prevention in the United Kingdom.
The use of mefloquine, for travellers, including military personnel, to high risk areas should be based on an individual risk assessment that takes into consideration the destination of travel, planned activities while travelling and the individual’s current health and medical history.
The ACMP regularly reviews data on safety and efficacy of all antimalarials. Whenever new evidence about antimalarials appears the ACMP considers this as part of its continuous process of developing advice.
The ACMP will be meeting in summer 2015 to finalise the 2015 revision of the ACMP guidelines. This meeting will review current evidence on the use of mefloquine, including data provided by Roche, and recommendations made by other countries including the United States with regard to the use of mefloquine for malaria prevention.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Ministry of Defence:
To ask Her Majesty’s Government how many service men and women who were deployed to Afghanistan between 2007 and 2014, and were required to take Lariam (mefloquine), subsequently required mental health treatment.
Answered by Earl Howe - Deputy Leader of the House of Lords
Between 1 April 2007 and 31 December 2014, 16,473 UK Regular Armed Forces personnel were prescribed mefloquine (commercial name Lariam). Up to 31 March 2015, 1,066 (6 per cent) were assessed as having a mental health disorder at their initial assessment at an MOD Department for Community Mental Health (DCMH) or on admission to an MOD in-patient provider. It is not possible from centrally-held data to identify whether an assessment is associated with a patient having taken mefloquine.
Former Service men and women are treated by the NHS and their status as a veteran is not always recorded on their NHS medical records. It is therefore not possible to say how many former Service personnel have required psychiatric treatment after taking mefloquine.
Between 1 April 2007 and 31 December 2014, 536 UK Armed Forces personnel were prescribed mefloquine prior to or whilst on deployment to Afghanistan. Up to 31 March 2015, 43 (8 per cent) were assessed as having a mental health disorder at their initial assessment at an MOD DCMH or on admission to an MOD in-patient provider.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Ministry of Defence:
To ask Her Majesty’s Government how many (1) serving and (2) former service men and women have required psychiatric treatment after taking Lariam (mefloquine).
Answered by Earl Howe - Deputy Leader of the House of Lords
Between 1 April 2007 and 31 December 2014, 16,473 UK Regular Armed Forces personnel were prescribed mefloquine (commercial name Lariam). Up to 31 March 2015, 1,066 (6 per cent) were assessed as having a mental health disorder at their initial assessment at an MOD Department for Community Mental Health (DCMH) or on admission to an MOD in-patient provider. It is not possible from centrally-held data to identify whether an assessment is associated with a patient having taken mefloquine.
Former Service men and women are treated by the NHS and their status as a veteran is not always recorded on their NHS medical records. It is therefore not possible to say how many former Service personnel have required psychiatric treatment after taking mefloquine.
Between 1 April 2007 and 31 December 2014, 536 UK Armed Forces personnel were prescribed mefloquine prior to or whilst on deployment to Afghanistan. Up to 31 March 2015, 43 (8 per cent) were assessed as having a mental health disorder at their initial assessment at an MOD DCMH or on admission to an MOD in-patient provider.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Ministry of Defence:
To ask Her Majesty’s Government what stocks of Lariam (mefloquine) they currently hold.
Answered by Earl Howe - Deputy Leader of the House of Lords
As at 22 June 2015, the Ministry of Defence holds 11,505 packs of mefloquine (commercial name Lariam) each containing eight tablets.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government on how many occasions the Advisory Committee for Malaria Prevention has met in the last two years.
Answered by Earl Howe - Deputy Leader of the House of Lords
Full meetings of the Advisory Committee for Malaria Prevention occurred in March and August of 2012 and January and December of 2013. The next full meeting is planned for January 2015. There was a sub-group meeting in 2014 to approve the 2014 version of the Guidelines for malaria prevention in travellers from the UK.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government what assessment the Medicines and Healthcare Products Regulatory Agency and the Advisory Committee for Malaria Prevention have made of the United States Food and Drug Administration's Safety Communication of 29 July 2013 warning of the risk of psychiatric and nerve side effects from taking Lariam (mefloquine) as a malaria prophylactic.
Answered by Earl Howe - Deputy Leader of the House of Lords
Mefloquine (brand name Lariam) is one of several drugs licensed for the prevention (chemoprophylaxis) or treatment of malaria. As with any medicine, mefloquine may cause side effects in some people and the potential risks should be balanced against the expected benefits of therapy. Information on possible side effects is available to the medical profession via the Summary of Product Characteristics (SmPC), and to patients via the Patient Information Leaflet.
In 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) strengthened the warnings in the mefloquine SmPC, particularly regarding the well-established risk of neuropsychiatric side effects. The licence holder (Roche) also issued a letter to healthcare professionals at the end of October 2013 to increase awareness of these possible risks, alongside a prescriber checklist and patient alert card to aid compliance with the warnings. In November 2013, the MHRA issued a further communication to healthcare professionals on the risks of mefloquine via its Drug Safety Update bulletin:
www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON336723
As with all medicines, the MHRA will keep the safety of mefloquine under continual review.
The Advisory Committee for Malaria Prevention (ACMP) carefully considered all available data following the Food and Drug Administration’s safety communication and subsequent modification of the SmPC by Roche in September 2013. SmPC recommendations for monitoring of liver function and eye assessment in long term use have also been added to the guidelines. The ACMP continues to believe that mefloquine is a valuable option for prophylaxis against malaria when appropriate risk assessments are undertaken.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty’s Government what the unit cost is of (1) Lariam (mefloquine), and (2) malarone.
Answered by Earl Howe - Deputy Leader of the House of Lords
The current edition of the British National Formulary lists the price of Lariam (mefloquine) as £14.53 for a pack of 8 tablets and the price of Malarone (proguanil hydrochloride with atovaquone) as £25.21 for a pack of 12 tablets.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Ministry of Defence:
To ask Her Majesty’s Government whether Lariam (mefloquine) is administered to pilots and air crew serving in the armed forces.
Answered by Lord Astor of Hever
As with all prescriptions the Ministry of Defence follows the drug manufacturer's advice which stipulates that Mefloquine (commercially known as Lariam) should not be taken if you are carrying out complex tasks such as driving, piloting an aircraft or diving. Accordingly, the Department's current policy is that aircrew are not to take Mefloquine.
Asked by: Baroness Corston (Labour - Life peer)
Question to the Ministry of Defence:
To ask Her Majesty’s Government how many serving (1) members of the armed forces, and (2) reservists, deployed to Sierra Leone in the ebola epidemic have been given Lariam (mefloquine) as a malaria prophylaxis.
Answered by Lord Astor of Hever
58 UK Armed Forces personnel who have been deployed on Operation GRITROCK before 31 October 2014 have been prescribed Mefloquine (commercially known as Lariam) as a malaria prophylaxis. All of these 58 were Regulars.
The exact choice of antimalarial drug used by the military depends on a number of factors, including the region the individual is deploying to, their health and any past history of side effects. Malarone is the first choice drug for those Service personnel deploying on Operation GRITROCK. For those individuals unable to tolerate Malarone the second choice is Mefloquine. Doxycycline will be offered to those individuals who cannot tolerate Malorone or Mefloquine.