E-drug: Medication Guide for Lariam
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FDA News 9 July 2003
P03-52 Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Creates Medication Guide for Lariam
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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