FDA Strengthens Warning on Lariam, Anti-Malaria Drug

Recently, the Food and Drug Administration (FDA) announced that the commonly used anti-malaria drug, called mefloquine hydrochloride (brand name Lariam) must have a “black box” warning on its label. The drug has been linked to serious neurological and psychiatric side effects with the potential to cause permanent damage.

A black box warning is the sternest warning from the FDA that a drug can have while remaining on the pharmaceutical market. The FDA can require a black box warning if the medication can cause serious, harmful side effects (such as life-threatening or permanently damaging reactions) in comparison to the potential benefits of using the drug, or if a serious, potentially life-threatening reaction can be prevented, reduced in frequency or reduced in severity with the proper use of the drug.

Mild to serious side effects associated with mefloquine include:

  • Ringing in the ears
  • Depression
  • Hallucination
  • Dizziness
  • Loss of balance
  • Psychiatric symptoms

The drug was first used in the U.S. Army and in 1989 it entered the commercial market. The manufacturer of Lariam, Roche, no longer sells it in the United States. However, generic versions are still available.

Mefloquine was previously favored among travelers because of its effectiveness in protecting against malaria and because it only needed to be taken once per week instead of once per day. Warnings on its label have steadily increased over the last decade.

According to the New York Times, mefloquine is the third-most-prescribed anti-malaria medication in the United States. Approximately 119,000 prescriptions have been written for the drug between January and June of this year.

The most common anti-malaria drug, hydroxychloroquine, was prescribed approximately 2.4 million times during that same time period.

Read the full story about Lariam and its strengthened warning now.

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