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FDA issues labeling requirements for blood-thinning drug

The FDA has issued new labeling requirements and an important warning about a popular drug. If you already use or are considering using the blood thinner Coumadin, this important information could affect you. The US Food and Drug Administration has issued its first genetic-based safety warning for a popular drug. The FDA estimates that every year two million people in the United States start taking the anticoagulant medication Warfarin -- best known by the brand name Coumadin -- to prevent blood clots, heart attacks and stroke. Warfarin is a blood thinner. It's a difficult drug to use because the optimal dose varies. Dosage depends on many risk factors including a patient's diet, age, the use of other medications and genetic makeup. Patients who take a dose larger than their bodies can tolerate are at risk of life-threatening bleeding. Those who receive not enough are at risk of equally dangerous blood clots. Determining the correct dosage is particularly important at the beginning of therapy, when adjusting the dose can lead to serious complications such as bleeding. The updated FDA warning comes after studies show that two specific genes cause higher risk for bleeding when patients take Warfarin. Certain genes change how the drug is processed in the body. The FDA warns that people at risk should start with lower than normal doses of Warfarin. Doctors can identify these genetic variations with a blood test. Warfarin is second only to insulin for sending people to the emergency room for adverse drug reactions. Doctors are hoping that using genetic testing to determine appropriate dosages will help cut down on the number of these emergencies.

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