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U.S. Department of Health and Human Services

Safety

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Lariam (mefloquine hydrochloride) Tablets September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

PRECAUTIONS

  • Central and Peripheral Nervous System Effects
    • ...In a small number of patients, dizziness and loss of balance have been reported to continue for months after mefloquine has been stopped (see ADVERSE REACTIONS: Postmarketing).
  • Information for Patients
    • Patients should be advised:
      • that in a small percentage of cases, patients are unable to take this medication because of side effects, including dizziness and loss of balance, and it may be necessary to change medications. Although side effects of dizziness and loss of balance are usually mild and do not cause people to stop taking the medication, in a small number of patients it has been reported that these symptoms may continue for months after discontinuation of the drug.

ADVERSE REACTIONS

  • Postmarketing
    • ...In a small number of patients it has been reported that dizziness or vertigo and loss of balance may continue for months after discontinuation of the drug.

MEDICATION GUIDE

  • What should I avoid while taking Lariam?
    • Lariam can cause dizziness or loss of balance, even after you stop taking Lariam (see “What are the possible side effects of Lariam?”).
  • What are the possible side effects of Lariam?
    • Loss of balance (added)
    • ...However, in a small number of patients, it has been reported that dizziness and loss of balance may continue for months after stopping Lariam.
    • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INFORMATION WALLET CARD

  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.