On December 13, 2006 the Food and Drug Administration stepped up its role in protecting the public health by cracking down on off-label uses of potentially dangerous drugs to treat relatively less serious conditions. There are a number of companies that market the drug quinine as an effective treatment for a leg cramps and other assorted conditions, but there is only one FDA-approved quinine product and it is intended to treat the tropical disease malaria.
Using drugs for off-label purposes is an extremely common practice in the United States, and many doctors have found that some drugs that are designed to treat certain conditions are reasonably safe and effective treatments for others. Although the FDA does not approve of these uses, it doesn’t exactly discourage either. Unfortunately, quinine is relatively unique in that an effective dose and a dangerous dose of the drug are almost identical, which means that even a small error in dosage can have severe and long-lasting consequences. This drug must only be prescribed by medical professionals that can weigh the potential benefits with the potential risks involved with the drug.
Quinine can cause a number of extremely serious side effects including:
• Birth Defects such as deafness • Miscarriage • Hemolytic anemia in some people • Cinchonism • Pulmonary Edema • Immune Thrombocytopenic Purpura
In addition, quinine can aggravate these conditions and should not be used in people with:
• Haemoglobinuria: high content of hemoglobin in urine • Myasthenia gravis: a neuromuscular disease that causes muscle weakness and fatigue • Optic Neuritis: inflammation of the optic nerve that can result in partial or total loss of vision • Atrial fibrillation • Heart blocks • Conduction defects
The consequences of off-label quinine use are tragic and heartbreaking. The FDA has received reports of 665 adverse reactions to quinine since 1969, and there have also sadly been 93 deaths due to unsupervised use of the drug. The FDA’s new aggressive response to off-label uses of quinine are intended to protect the health and safety of the public and set an example to other companies that attempt to market potentially-dangerous substances as safe. These actions will hopefully save untold lives in the years to come.
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