On December 11, 2006, the Food and Drug Administration ordered pharmaceutical firms to halt all manufacturing and marketing of unapproved drug products that contain quinine due to potentially fatal side effects. There are a number of quinine-containing products sold throughout the United States, but there is only one product currently approved by the FDA.
Quinine is traditionally associated with treatments for the deadly tropical disease malaria, but doctors also prescribe it for a number of "off-label" uses such as treating leg cramps or other similar conditions. These off-label prescriptions are not approved by the FDA, and are usually up to the discretion of the prescribing doctor.
This action by the FDA means that companies can no longer manufacture new unapproved quinine-containing products. The only FDA-approved quinine-containing drug is Mutual Pharmaceutical Company, Inc.'s Qualaquin, and it is used only to treat complication-free malaria because the potential benefits of quinine outweigh the dangers.
There have been 665 reports of severe reactions to quinine, and 93 people died due to his drug. Some of the most dangerous side effects include:
- Cardiac arrhythmias
- Thrombocytopenia (a decrease in blood platelets that can cause hemorrhage or clotting problems)
- Severe hypersensitivity reactions
- Quinine is also known to interact dangerously with a number of other drugs
There are a number of other reasons that quinine is so strictly regulated. One reason is because the dosage of the drug is critical and must be monitored by trained professionals. The FDA-approved label indicates there are serious risks associated with quinine because there is an extraordinarily slim margin between an effective dose and a toxic dose.
Another reason is the FDA is cracking down on unapproved drugs in order to affirm its initiative to ensure the people and healthcare providers have as much information available to them about the drugs they introduce into their bodies so that they can make a reasoned and best-possible medical decision about their health.
If you or someone you love has been injured by quinine, you may be entitled to compensation for your pain and suffering. You must act quickly, for if you hesitate the statute of limitations in your state could affect how long you have to file a lawsuit. Let us help you get the financial reward that could offset your medical bills. Contact us today.
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people on this site are real or have had their health harmed or affected from using Quinine.
