| Mefloquine Hydrochloride: Drug Safety Communication - Label Changes Due To Risk of Serious Psychiatric and Nerve Side Effects
AUDIENCE: Infectious Disease, Emergency Medicine, Psychiatry, Pharmacy, Patient
ISSUE: FDA is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning, the most serious kind of warning about these potential problems, has been added to the drug label. FDA has revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the neurologic side effects may persist or become permanent. The neurologic side effects can include dizziness, loss of balance, or ringing in the ears. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations.
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. See the Drug Safety Communication for more information, including a data summary.
BACKGROUND: Mefloquine hydrochloride is indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible P. falciparum and P. vivax, and prevention of malaria infections by P. falciparum (including chloroquine-resistant P. falciparum) and P. vivax. It was previously marketed under the brand name Lariam; however, the Lariam product is not currently marketed. Generic mefloquine products are available in the US.
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.
For additional information for health care professionals and patients, refer to the Drug Safety Communication.
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: www.fda.gov/MedWatch/report.htm
‧ 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
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA新增警語並告知大眾，抗瘧疾藥品mefloquine hydrochloride可能會引起神經精神相關副作用。神經相關副作用包含頭暈、暈眩或耳鳴；精神副作用如焦慮、缺乏安全感、憂鬱或產生幻覺。這些副作用可能於用藥期間發生，且停藥後也可能持續幾個月至幾年，甚至永久。
背景：Mefloquine hydrochloride的適應症為治療由對mefloquine具感受性之惡性瘧原蟲 (P. falciparum) 或間日瘧原蟲 (P. vivax) 引起的中至重度急性瘧疾，以及預防瘧疾感染。
病人、照顧者及醫療人員應密切注意此藥之副作用。當病人服用此藥預防瘧疾時，若出現神經或精神相關症狀，應立即停藥，並改用替代藥品。若病人自覺出現以上症狀，請勿自行停藥，應盡速與醫療人員聯繫。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362887.htm
[Posted 07/30/2013]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部 |
資料來源：藥師週刊（第1836期）