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Severe Neuropsychiatric Adverse Effects Associated With The Antimalarial Drug Mefloquine (LARIAM)

Worst Pills, Best Pills Newsletter article September, 2003

This was also the title of an article appearing in the third issue of Worst Pills, Best Pills News in May 1995, about the serious, neuropsychiatric, adverse effects associated with the use of mefloquine (LARIUM), a drug used most often to prevent malaria in international travelers. In this article we advised:

Tell your physician not to prescribe mefloquine if you or someone you know has a history of psychiatric disturbances or convulsions. If mefloquine is prescribed, care should be...

This was also the title of an article appearing in the third issue of Worst Pills, Best Pills News in May 1995, about the serious, neuropsychiatric, adverse effects associated with the use of mefloquine (LARIUM), a drug used most often to prevent malaria in international travelers. In this article we advised:

Tell your physician not to prescribe mefloquine if you or someone you know has a history of psychiatric disturbances or convulsions. If mefloquine is prescribed, care should be exercised with regard to driving and operating machines since dizziness, a disturbed sense of balance, and other neuropsychiatric effects have been associated with this drug. Some authorities do not recommend the drug for pilots because of its neuropsychiatric effects. Mefloquine has shown birth defects in animals so caution is advised in pregnancy and breast feeding mothers. During prophylactic use, if signs of unexpected anxiety, depression, restlessness or confusion are noticed, the drug must be discontinued.

On July 9, 2003, almost eight years after our warning, the Food and Drug Administration (FDA) has finally required the manufacturer of mefloquine, Roche Laboratories Inc. of Nutley, NJ, to produce information written specifically for patients that must be distributed with each new and refill prescription of the drug. This information is known as a Medication Guide or MedGuide and is reserved for prescription drugs that pose a “serious and significant public health concern requiring immediate distribution of FDA-approved patient medication information.”

The Health Research Group has been advocating the mandatory distribution of FDA-approved patient drug information for more than 20 years for all drugs. Our efforts have largely fallen on deaf ears at the FDA and, to date, the FDA has only required Medication Guides for 13 drugs.

The following is taken directly from the FDA-required Medication Guide of mefloquine and it bears some striking similarities to the advice we gave in Worst Pills, Best Pills News eight years ago:

Lariam can rarely cause serious mental problems in some patients. The most frequently reported side effects with Lariam, such as nausea, difficulty sleeping, and bad dreams are usually mild and do not cause people to stop taking the medicine. However, people taking Lariam occasionally experience severe anxiety, feelings that people are against them, hallucinations (seeing or hearing things that are not there, for example), depression, unusual behavior, or feeling disoriented. It has been reported that sometimes, in some patients, these side effects continue after Lariam is stopped. Some patients taking Lariam think about killing themselves, and there have been rare reports of suicides. We do not know if Lariam was responsible.

Who should not take Lariam?

Do not take Lariam to prevent malaria if you:

• have depression or had depression recently
• have had recent mental illness or problems, including anxiety disorder, schizophrenia (a severe type of mental illness), or psychosis (losing touch with reality)
• have or had seizures (epilepsy or convulsions)
• are allergic to quinine or quinidine (medicines related to Lariam)

Tell your prescriber about all your medical conditions. Lariam may not be right for you if you have certain conditions, especially the ones listed below:

• Heart disease. Lariam may not be right for you.
• Pregnancy. Tell your prescriber if you are pregnant or plan to become pregnant. It is dangerous for the mother and for the unborn baby (fetus) to get malaria during pregnancy. Therefore, ask your prescriber if you should take Lariam or another medicine to prevent malaria while you are pregnant. • Breast feeding. Lariam can pass through your milk and may harm the baby. Therefore, ask your prescriber whether you will need to stop breast feeding or use another medicine.
• Liver problems.

What You Can Do

If you have been prescribed mefloquine to prevent malaria, read the Medication Guide before taking the drug. If you have questions, consult the prescriber.