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Due to serious drug side effect risks, the FDA has ordered all manufacturers to stop marketing quinine products for off-label, non-approved uses. While several unapproved quinine products have flooded the market, only one product is approved for the treatment of malaria. While quinine is only approved for the treatment of this life-threatening disease, it has become a popular drug for the treatment of leg cramps. Thousands of patients have used quinine for this off-label purpose.

Experts are now cautioning consumers against using quinine to treat leg cramps because of the potentially deadly side effects associated with this off-label use. As the FDA explains, quinine use is justified for the treatment of malaria, because this disease is life-threatening. However, the potential risks of using quinine for the treatment of leg cramps clearly outweigh the possible benefits.

If you or a loved one has taken quinine for the treatment or prevention of leg cramps and have suffered serious injury or death, you may wish to contact us to consult with a qualified attorney who can evaluate your case. You may be eligible to seek compensation for your losses and suffering. Our experienced quinine attorneys are available to help. Read on to learn more about the risks of off-label quinine use and your legal rights.

What is quinine?

Quinine, or quinine sulfate, has long been used to treat the serious and life threatening disease malaria. Quinine is a naturally occurring plant substance indigenous to South America. Native tribes there discovered the benefits of using quinine to treat malaria hundreds of years ago and it has since become a valuable treatment for malaria throughout the world.

Currently, only one product—Qualaquin, manufactured by Mutual Pharmaceutical Company—is approved for the treatment of malaria. The FDA has not approved any quinine product for the treatment or prevention of leg cramps.

The history of quinine leg cramp treatment

The side effects of quinine have been well understood for many years. For over a decade, the FDA has tried to restrict the use of quinine for off-label uses because of these serious risks.

In 1995, the FDA removed all over-the-counter quinine sulfate products from the market, due to serious safety concerns. At this time, quinine was still available in prescription strength and was prescribed for leg cramps. In late 1995, however, the FDA ruled that quinine could no longer be prescribed for leg cramps because the risks clearly outweighed the benefits.

Despite this FDA quinine ruling, thousands of people continued to receive quinine for the treatment and prevention of leg cramps.

Quinine side effect risks

Quinine poses serious and potentially deadly risks. These side effects clearly outweigh the potential benefits of using this drug for the treatment or prevention of nocturnal leg cramps. Quinine adverse reactions include:

  • Cardiac arrhythmias. This potentially serious condition causes irregularities in the sequence of heartbeats. Quinine cardiac arrhythmias can produce anxiety and, more seriously, impair the heart’s ability to properly pump blood. Drug treatments, artificial pacemakers, and other treatments may be necessary to address this condition.
  • Thrombocythemia. This is a quinine side effect that causes the body to produce excess platelets, which leads to abnormal blood clotting or bleeding. This condition doesn’t often produce symptoms, though it can cause the formation of blood clots. Symptoms of blood clots can include tingling the extremities, cold fingertips, headaches, dizziness, and weakness. Nosebleeds, bruising easily, digestive tract bleeding, and gum oozing are also possible symptoms. Drug treatment is often required for this serious condition.
  • Cinchonism. This condition is characterized by headaches, nausea, ringing of the ears, visual impairment, stomach pain, rashes, diarrhea, vertigo, and vomiting.
  • Hypersensitivity reactions. Symptoms of this quinine side effect include hives, skin flushing, fever, facial swelling, and more.
  • Drug interactions. When quinine is taken concurrently with mefloquine, it can increase the risk of seizures, heart arrhythmias, and other serious reactions. Other concurrent drug use may also pose serious risks.
  • Contraindications. Patients with any of these condition may be at an increased risk of quinine side effects: tinnitus (or ringing of the ears), certain visual conditions, and more.
  • Quinine overdose. Another serious risk posed by quinine use is the potential to receive a toxic dose. The difference between correct dose and overdose is very small with quinine. If a patient suffers a quinine overdose it can cause serious damage and may be lethal. Symptoms can include gastrointestinal side effects, cardiotoxicity, visual disturbances, central nervous system disturbances, and more.

Since 1969, the FDA has received 665 reports of serious adverse reactions caused by quinine. The agency has received reports of almost 100 deaths caused by quinine. In light of these grave risks, the FDA urges patients not to use quinine for the treatment or prevention of leg cramps.

Recent FDA action over quinine

On December 11, 2006, the FDA ordered that all manufacturers of unapproved quinine drugs immediately stop marketing these dangerous products. The agency ordered these companies to cease manufacturing of new quinine products within 60 days. While some illegal quinine products might remain on the shelves for a short period, the FDA cautioned consumers against the use of these drugs. Patients using quinine leg cramp treatments are urged to speak with their health care providers. This action is part of a larger push by the FDA to crack down on the makers of unapproved drug products.

Alternatives to Quinine Cramp Treatments

Though quinine is not a safe choice for the prevention and treatment of leg cramps, some alternative treatments can be effective. According to the Mayo Clinic, there are ways to treat leg cramps at home, such as:

- Massage the affected muscle
- Walking
- Straighten the affected leg and flex your foot towards you until you feel you calf muscle stretch out.
- Apply a cold compress to the affected area
- Take a hot bath

In order to prevent leg cramps, experts recommend that a patient drink plenty of fluids (especially water) throughout the day, make sure to get enough potassium and vitamin B12 in your diet (bananas, for example, are a good source of potassium), and stretch your legs prior to retiring to bed each night. If your leg cramps persist, you should talk to your doctor about alternative treatments to quinine.

What to do if you have been harmed by quinine
If you or a loved one has suffered a serious injury caused by quinine leg cramp medication, you may be eligible to seek compensation for your medical expenses, time out of work, loss of income, pain and suffering, and more.

Our qualified quinine lawyers are standing by and prepared to protect you and your family. We can evaluate your case free of charge to determine the best way to protect your legal interests and get you the compensation you deserve. Please contact us today.

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