Medicinal Products Licensing

Dáil Éireann Debate, Tuesday - 2 February 2016

Tuesday, 2 February 2016

Questions (414)

Seán Crowe

Question:

414. Deputy Seán Crowe asked the Minister for Health if the Health Products Regulatory Authority, formerly the Irish Medicines Board, received proof or assurances from Roche Pharmaceuticals that all clinical trials phases were completed for the licensing of Lariam as a prophylaxis and preventive drug for malaria; and if the authority or Roche Pharmaceuticals recommended that users should take 250 milligrams of Lariam one week prior to departure to a malaria zone. [4464/16]

Written answers

Minister of State at the Department of Health

Lariam (mefloquine hydrochloride) is used as malaria prophylaxis as well as a treatment for a specific form of malaria that has become resistant to other antimalarial treatments.

The HPRA has confirmed that the safety and efficacy of the product were established through an evaluation of the results of relevant pre-clinical and clinical studies before it was licensed in 1989, with an approved dose of 250mg to be taken one week before travelling to an area with malaria.

The data submitted by Roche, including the clinical trial data, demonstrated that the benefits of this treatment outweighed its risks. The HPRA, together with its EU counterparts, considers that the benefits of treatment with Lariam outweigh the risks, when it is used in accordance with the conditions and guidance contained in the approved product information. The safety of this medicine, as with all medicines, continues to be carefully monitored, and systems are in place to review any new safety signal, should they arise.