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Black Box Warning Added to Common Malaria Drug

Jul 30, 2013

Federal health authorities are requiring a Black Box warning on the label of a commonly used malaria drug because some side effects linked to it may be permanent.

The New York Times reports that the U.S. Food and Drug Administration (FDA) is mandating its strongest warning be placed on Lariam (mefloquine hydrochloride) because of both neurological and psychiatric side effects that have been linked to its use. Some of these side effects could be permanent, a fact that pushed the FDA to require the additional warnings.

Lariam has been linked in the past to numerous side effects, including ringing in the ears, depression, and dizziness, as well as hallucinations and loss of balance. Some people who’ve taken Lariam in the prevention or treatment of malaria have been permanently stricken with these side effects, especially dizziness and loss of balance. For many who take Lariam, the side effects continue for months after the drug treatment has been stopped, according to The New York Times.

Lariam is no longer sold in the U.S. under its brand name but is available as the generic mefloquine hydrochloride. The New York Times reports that, as side effect warnings have been added to the drug’s label — mostly in the past 10 years — more people in the U.S. have been prescribed other malaria drugs.

The FDA warns that “neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent. Patients, caregivers, and healthcare professionals should watch for these side effects. When using the drug to prevent malaria, if a patient develops neurologic or psychiatric symptoms, mefloquine should be stopped, and an alternate medicine should be used.”

The New York Times also notes that hallucinations and strange dreams linked to people who’ve used Lariam have become somewhat mythological. The drug Lariam has also been implicated in cases of violence among people serving in the U.S. military. Lariam was commonly prescribed to soldiers.

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