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7/11/2003

Medication Guide to be Distributed with Mefloquine, FDA Says

Donna Young

The Food and Drug Administration on Wednesday announced that a medication guide (PDF) must be distributed with all dispensed prescriptions of mefloquine hydrochloride, or Lariam, a drug prescribed to people traveling to malaria-affected countries as a preventive treatment for the disease.

Roche Pharmaceuticals, the manufacturer of the drug, revised the labeling for mefloquine in September 2002 to warn of dangerous psychiatric adverse events, particularly among patients who already suffer from a psychiatric disorder.

The company warned that patients with depression, generalized anxiety disorder, psychosis, schizophrenia, or other major psychiatric illness should not use the drug.

FDA collaborated on developing the guide with Roche, according to an agency statement.

Roche is issuing "Dear Healthcare Professional" and "Dear Pharmacist" letters about the guide, according to FDA. However the agency did not specify a date for the letters to be issued or when the guides would be made available.

The medication guide, FDA stated, instructs patients who experience a sudden onset of anxiety, depression, restlessness, or confusion to contact a physician or other health care provider.

The guide also includes information about preventing malaria, warnings about who should not take mefloquine, how the drug should be taken, and a list of the most common adverse effects associated with the drug.