FDA Adds Boxed Warning to Malaria Drug Label

The FDA advised the public about new and stronger warnings regarding the neurologic and psychiatric side effects associated with the anti-malarial drug mefloquine hydrochloride. The agency has revised the patient medication guide to reflect the new information and added a boxed warning to the drug label. Recommendation: Patients, caregivers, and health care 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. If a patient develops neurologic or psychiatric symptoms while on mefloquine, the patient should contact the prescribing health care professional. The patient should not stop taking mefloquine before discussing symptoms with the health care professional. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: Click Here Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical...