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FDA developed the Lariam Medication Guide in collaboration with the drug's manufacturer, Roche Pharmaceuticals of Nutley, N.J., to help ensure patients understand the risks of malaria, and the rare but potentially serious psychiatric adverse events associated with use of Lariam. It also provides information on how they can recognize these psychiatric risks and take early action to prevent serious harm.

Specifically, the Lariam Medication Guide instructs patients who experience a sudden onset of certain psychiatric adverse events – anxiety, depression, restlessness or confusion – to contact a doctor or other healthcare provider because it may be necessary to stop taking Lariam and use another malaria prevention medicine.

Sometimes these psychiatric adverse events may persist even after stopping the medication. Some rare reports have claimed that Lariam users think about killing themselves. There have been rarer reports of suicides, although FDA does not know if Lariam use was related to these suicides.

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