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The Food and Drug Administration (FDA) today announced the development of a Medication Guide (FDA-approved patient labeling) to provide better information to consumers about the risks and benefits of Lariam (mefloquine hydrochloride), and to educate patients on the measures to be taken to optimize Lariam's effectiveness. Lariam is a valuable drug in helping to prevent malaria, but in rare instances it has been associated with serious psychiatric adverse events.
"The Lariam Medication Guide is an important new tool for managing the risks of Lariam, one of the most highly effective means of combating one of the deadliest diseases in the world," said Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., "This guide will help patients and physicians maximize the drug's benefits and minimize its risks." Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research (CDER) added, "Lariam can work in certain areas where malaria is resistant to other drugs and it offers several other advantages including its once weekly dosing, the ability to use it in children, and the fact that it does not sensitize people to sunlight."
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.
The Lariam Medication Guide also highlights other important general information about preventing malaria and the safe and effective use of Lariam, including who should not take Lariam, how Lariam should be taken, what should be avoided while taking Lariam and a list of the most common side effects of Lariam such as bad dreams, difficulty sleeping, nausea and vomiting.
In conjunction with the development of the Lariam Medication Guide, Roche Pharmaceuticals is issuing a "Dear Healthcare Professional" letter to alert prescribers to the new patient labeling and a "Dear Pharmacist" letter to remind pharmacists of their obligation to provide patients a Medication Guide with each Lariam prescription filled.
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