Published: Jul 30,
2013
By Nancy Walsh, Staff
Writer, MedPage Today
The
FDA has added a boxed warning to the labeling of the antimalarial drug
mefloquine, advising of the possibility of neurologic and
psychiatric adverse events, the agency announced.
Mefloquine
hydrochloride is used for the prevention of malaria caused by Plasmodium falciparum,
including chloroquine-resistant strains, and P. vivax, and for the
treatment of mild-to-moderate disease.
The
drug initially was developed
by the U.S. military in the early 1970s, at a time when chloroquine
resistance was on the rise, and even during initial testing there were reports
of neurologic problems.
Its
proprietary formulation, Lariam, is no longer available in the U.S., but
generics remain on the market.
The
neurologic side effects include dizziness, vertigo, tinnitus, and loss of
balance relating to vestibular damage, as well as seizures and
insomnia.
Psychiatric
adverse events include depression, hallucinations, confusion, paranoia, anxiety,
and restlessness.
These
events can be particularly difficult to diagnose in children, according to the
FDA statement.
In
some reported cases, both neurologic and psychiatric symptoms were persistent or
permanent, and developed after just one or two doses of the drug in individuals
who were otherwise healthy.
A
Cochrane review also identified 22
cases of deaths, including five suicides, linked with mefloquine
use.
Information
about the adverse events will be included in the patient information and wallet
card provided with each prescription of mefloquine.
Patients
also will be advised to contact their healthcare provider if these symptoms
develop, but not to stop taking the medication unless told to do
so.
The
agency also encouraged clinicians to report any adverse reactions associated
with mefloquine to the FDA's MedWatch program,
noting that it will continue to evaluate the drug's
safety.
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