Mefloquine: strengthened warnings on neuropsychiatric side effects

A recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks. To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in patients with active or a history of psychiatric disturbances such as depression, anxiety disorders, schizophrenia, or other psychiatric disorders. If neuropsychiatric reactions or changes to mental state occur during mefloquine chemoprophylaxis, the patient should be advised to stop taking mefloquine and seek medical advice as soon as possible so that it can be replaced by another medicine for malaria prevention

Article date: November 2013

Mefloquine (brand name Lariam) is used for prophylaxis and treatment of Plasmodium falciparum malaria. Official guidance on the appropriate use of antimalarial medicines and the prevalence of resistance should be considered when prescribing mefloquine (see further information links below).

Although the potential for neuropsychiatric side effects with mefloquine is a well-established risk, a recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks. The overall safety profile of mefloquine has also been clarified in the product information.

Updated information and advice for healthcare professionals:

  • Psychiatric symptoms associated with use of mefloquine such as nightmares, acute anxiety, depression, restlessness, or confusion should be regarded as potentially prodromal for a more serious event
  • Cases of suicide, suicidal thoughts, and self-endangering behaviour such as attempted suicide have been reported in association with use of mefloquine
  • Adverse reactions may occur and persist up to several months after discontinuation of mefloquine because of its long half-life. In a small number of patients, dizziness or vertigo and loss of balance have been reported to continue for months after discontinuation of the drug
  • To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in patients with active or a history of psychiatric disturbances such as depression, anxiety disorders, schizophrenia, or other psychiatric disorders
  • If neuropsychiatric reactions or changes to mental state occur during mefloquine chemoprophylaxis, the patient should be advised to stop taking mefloquine and seek medical advice as soon as possible so that it can be replaced by another medicine for malaria prevention
  • Suspected adverse reactions to mefloquine should be reported to us on a Yellow Card. This includes reports from patients and the public, who can report directly or you can do it on their behalf (www.mhra.gov.uk/yellowcard)

The Marketing Authorisation (licence) Holder is issuing a letter to healthcare professionals, a prescriber checklist, and patient alert card to aid compliance with these warnings, and to ensure patients are more aware of the neuropsychiatric side effects and to react promptly when these occur in malaria chemoprophylaxis.

Further information:

BNF section 5.1: Antimalarial drugs

Public Health England

Royal College of General Practitioners

Advisory Committee on Malaria Prevention Guidelines 2013

Malaria Reference Laboratory

See also letter sent to healthcare professionals sent Oct 31, 2013

Article citation: Drug Safety Update volume 7 issue 4, November 2013: A5.

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