[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.
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush or chew. Take with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not skip doses or stop your medicine early even if you feel better. Do not stop taking except on your doctor's advice.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular check ups. Let your doctor know if your symptoms do not improve or if you feel worse. Contact your doctor right away if your fevers come back after you finish this medicine.
Some people may have low blood sugar while taking this medicine. Low blood sugar can make you feel lightheaded, dizzy, sweaty, confused, shaky, anxious, or weak. If you feel this way drink some fruit juice or have a snack then call your doctor. If you are diabetic, check your blood sugar as directed.
Avoid antacids with aluminum or magnesium for 2 hours before and after taking a dose of this medicine.
Tell your health care provider that you are taking this medicine before you have any surgery, procedure, or dental work.
FDA Alerts
Media Gallery
