Drug Notebook

FDA Alerts

Special Alerts:

[Posted 12/12/2006] FDA informed healthcare professionals and consumers that the Agency ordered firms to stop marketing unapproved drug products containing quinine, citing serious safety concerns, including deaths associated with quinine products. There are multiple unapproved products containing quinine currently on the market, used off-label to treat leg cramps and similar conditions. Since 1969, FDA received 665 reports of adverse events with serious outcomes associated with quinine use, including 93 deaths. Quinine drugs are associated with serious side effects, such as cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions. Qualaquin, manufactured by Mutual Pharmaceutical Company, is the only quinine product approved by the FDA. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Quinine and http://www.fda.gov/bbs/topics/NEWS/2006/NEW01521.html.

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What is the most important information I should know about quinine?

The U.S. Food and Drug Administration has banned the sale of all non-approved brands of quinine because of the risk of serious side effects or death. As of December 2006, Qualaquin is the only brand of quinine that is approved by the FDA.

Quinine can cause serious or life-threatening side effects, and is approved for use only in treating malaria. Some people have used quinine to treat leg cramps, but this is not an FDA-approved use. Do not use quinine to treat any medical condition if your doctor did not prescribe quinine for that condition. Do not purchase quinine on the Internet or from vendors outside of the United States. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

Do not use this medication if you have ever had an allergic reaction to quinine or similar medicines such as mefloquine (Lariam) or quinidine (Cardioquin, Quinidex, Quinaglute).

You should not take quinine if you have a history of "Long QT syndrome", or if you have glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, myasthenia gravis, or optic neuritis (inflammation of the nerves in your eyes).

Call your doctor at once if you have a weak pulse, if you faint or collapse, if you have fever, confusion, pale or yellowed skin, dark colored urine, hearing or vision loss, purple spots under your skin, a blistering or peeling skin rash, or if you urinate less than usual or not at all.

No medication is 100% effective in treating malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

What is quinine?

The U.S. Food and Drug Administration has banned the sale of all non-approved brands of quinine because of the risk of serious side effects or death. As of December 2006, Qualaquin is the only brand of quinine that is approved by the FDA.

Quinine is used to treat malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Quinine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking quinine?

Quinine can cause serious or life-threatening side effects, and is approved for use only in treating malaria. Some people have used quinine to treat leg cramps, but this is not an FDA-approved use. Quinine will not treat severe forms of malaria, and it should not be taken to prevent malaria. Quinine also should not be taken to treat or prevent night-time leg cramps. Do not use this medication if you have ever had an allergic reaction to quinine or similar medicines such as mefloquine (Lariam) or quinidine (Cardioquin, Quinidex, Quinaglute), or if you have:
  • a history of "Long QT syndrome";

  • glucose-6-phosphate dehydrogenase (G-6-PD) deficiency;

  • myasthenia gravis; or

  • optic neuritis (inflammation of the optic nerve).

Before taking quinine, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may not be able to use quinine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. Quinine may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hypoglycemia (low blood sugar) may be more likely to occur in pregnant women who are taking quinine. Signs of low blood sugar include hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, and fast heartbeat. Talk to your doctor about your specific risk for low blood sugar if you take quinine while you are pregnant. Quinine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 16 years old.
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