USA. The US FDA, in collaboration with Roche Pharmaceuticals, has developed a Medication Guide (US FDA-approved patient labelling) for the antimalarial agent mefloquine (Lariam); it includes the addition of a warning that, in rare cases, the drug has been associated with severe psychiatric events such as suicidal thoughts. The guide will provide improved information on the risks and benefits associated with the use of mefloquine (Lariam) and educate patients about how to optimise the drug’s effectiveness. It will help ensure patients understand the risk of rare but potentially serious psychiatric adverse events associated with the use of mefloquine (Lariam) and will contain information on how patients can recognise the psychiatric risks and take early action to avoid serious harm. Specifically, the guide instructs patients who experience a sudden onset of anxiety, depression, confusion or restlessness to see a physician or other healthcare provider, as it may be necessary to discontinue mefloquine (Lariam). It also notes that there have been rare reports of suicidal thoughts and more rarely, of suicide in mefloquine (Lariam) users, although a relationship with the drug has not been established.
Media Release: 09 Jul 2003. Available from URL: http://www.fda.gov