Safety Alerts & Recalls
What does this mean?
Because use of quinine sulfate for the treatment of nighttime leg cramps may cause serious side effects, if you take quinine sulfate for nighttime leg cramps you should review the risks and benefits of this medicine with your doctor or other healthcare professional.
The FDA offers the following advice for patients who take quinine sulfate or the brand Qualaquin:
1) If you take this medicine for nighttime leg cramps, you should discuss other treatment options with your healthcare professional.
2) Contact your health care professional immediately if you experience easy bruising, severe nose bleeding, blood in your urine or stool, bleeding gums, or the appearance of unusual purple, brown, or red spots on your skin.
3) Read the medication guide given to you at the pharmacy when you pick up a prescription for quinine sulfate (Qualaquin).
4) Report any side effects with the use of quinine sulfate (Qualaquin) to FDA's MedWatch Adverse Event Reporting Program by phone at 1-800-332-1088; by fax at 1-800-332-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.
FDA Warns Using Malaria Medication for Leg Cramps Can Lead to Serious Side Effects
The U.S. Food and Drug Administration (FDA) today warned that the unapproved use of the malaria drug quinine sulfate to treat night time leg cramps has resulted in serious side effects.
Quinine sulfate, commonly called just "quinine," is sold under the brand name Qualaquin. Qualaquin is FDA-approved only to treat a certain type of malaria (uncomplicated malaria). This infection, which is rare in the United States, is found mainly in travelers who have been to countries where malaria occurs. Most of Qualaquin's use in the U.S. is for the treatment or prevention of nighttime leg cramps, a use not approved by FDA.
FDA has received reports of side effects after people used Qualaquin to prevent or treat leg cramps or restless leg syndrome. In some patients, these side effects resulted in permanent kidney damage and hospitalization. Two patients died. Most of those reporting serious side effects took the drug to prevent or treat leg cramps or restless leg syndrome.
Reported side effects of Qualaquin include: serious bleeding due to a severe lowering of blood cells called platelets (thrombocytopenia); a condition that may result in permanent kidney damage; heart and blood vessel (cardiovascular) problems; hearing loss; and electrolyte imbalance.
Because of these serious side effects, the manufacturer has developed a risk management plan for Qualaquin aimed at educating health care professionals and patients about the potential risks.
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