Side Effects of Quinine for Leg Cramps
Quinine (also called Quinine sulphate or sulfate) is used to treat uncomplicated malaria caused by the parasite Plasmodium falciparum. There is one FDA approved prescription medication for this use called Qualaquin, manufactured by Mutual Pharmaceuticals Inc. Quinine was used as an off-label use for the treatment of nighttime leg cramps. However, due to safety concerns, including deaths associated with quinine use, the FDA ordered all firms to stop marketing unapproved quinine products. As of June 2007, per FDA Import Alerts, "no unapproved finished drug products containing quinine, quinine sulfate, and any other salt of quinine may be allowed entry."
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Considerations
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If quinine is used for malaria, why should it be banned for the use of leg cramps? Although quinine is FDA approved, the side effects from quinine can be severe. Since malaria is a serious and life-threatening disease, the FDA approved its use despite the risks. The agency does not feel the risks associated outweigh the benefits for using quinine for leg cramps.
The Facts
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According to the FDA's December 11, 2006 News Release, "Quinine is a drug with a narrow margin between an effective dose and a toxic dose. The dosing for the approved drug is supported by data to maximize the safety and efficacy of the product." The problem when using quinine for leg cramps is that the dosing was not tested nor was it reviewed or approved by the FDA. Safety becomes a factor for the unapproved use. The FDA-approved drug lists extensive warnings on its labeling about serious adverse effects with quinine use, including potentially serious interactions with other drugs and conditions where quinine should not be used. The unapproved products would not list these warnings.
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Warning
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Serious side effects from use of quinine include cardiac arrhythmias, thrombocytopenia, a decrease in blood plateles that can cause clotting problems or hemorrhage and severe hypersensitivity reactions. Between 1969 and 2008, the FDA received 665 reports of adverse events associated with quinine use, including 93 deaths.
Adverse Effects
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If quinine levels are too high in the body, serious side effects or even death can occur. The approved drug, Qualaquin's patient information leaflet discusses quinine and bleeding, especially when taken for the non-approved condition of leg cramps: "If you notice easy bruising, bleeding, or a nonfading pinpoint type rash (which may be due to small bleeds under the skin) call your doctor immediately." The labeling warns that Qualaquin should be stopped immediately if it is taken for any other reason other than for malaria treatment.
Effects
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Since taking quinine is no longer an option, what else is there? Drinking lots of fluids throughout the day to avoid dehydration and stretching the calf muscles before going to bed may prevent the leg cramps. Consult your physician to find out if drugs such as gabapentin, Requip, verapamil, diltiazem or muscle relaxants might provide relief.
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