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Unapproved Qualaquin Use Is Risky

FDA Issues New Warning About Using Malaria Drug Qualaquin to Treat or Prevent Nighttime Leg Cramps
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Reporting Qualaquin Side Effects continued...

The company is required to issue a letter to health care providers warning of the potential risk of serious and life-threatening blood-related reactions.

The FDA approved Qualaquin in August 2005 to treat uncomplicated malaria caused by the parasite Plasmodium falciparum, an infection that can be life-threatening if not treated.

Health care professionals and patients may report serious side effects online to the FDA’s MedWatch Adverse Event Reporting program, by regular mail, phone, or fax. Side effects can be reported by regular mail with a pre-addressed FDA form, available at the same web site, or by fax to 800-FDA-0178 or phone to 800-332-1088.

More information is available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218202.htm, and a FDA consumer article is available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm217599.htm.

FDA's Advice on Qualaquin

The FDA offers this advice for consumers:

  • If you take Qualaquin for nighttime leg cramps, discuss other treatment options with your doctor.
  • Contact your doctor immediately if you experience easy bruising, severe nose bleeding, blood in your urine or stools, bleeding gums, or the appearance of unusual purple, brown, or red spots on the skin.
  • Read the medication guide provide by the pharmacy when you pick up a prescription for Qualaquin.
  • Report any side effects to the MedWatch Adverse Event Reporting Program.

The FDA says the medication guide spells out what Qualaquin is approved and not approved for, as well as its potential side effects.

The FDA had previously warned Americans in late 2006 not to use quinine for leg cramps. It said then that it had received 665 reports of serious adverse events linked to quinine, including 93 deaths.

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