FDA Updates Prescription Guidelines for Blo... (nals may well decide to incorporate gene...)

FDA Updates Prescription Guidelines for Blood Thinner

Date:8/18/2007

nals may well decide to incorporate genetic information along with more traditional risk factors in estimating their patient's warfarin doses," Lesko said. "It may improve the safe use of warfarin."

Lesko noted that genetic tests for the gene variants can cost $125 to $500. The tests may not be readily available in some parts of the United States, he said.

Dr. Janet Woodcock, the FDA's deputy commissioner and chief medical officer, noted during the teleconference that there isn't enough data to make genetic testing a mandate when prescribing warfarin.

"We have to test how good it will be to use genetic information versus the current methods, which are not perfectly satisfactory, but work to initiate warfarin therapy. Then we will have an answer to that question," Woodcock said.

Warfarin is the second most common drug to blame for emergency room visits for adverse drug events, after insulin, the FDA said.

Currently, patients need to have several blood tests over several weeks to determine their optimal warfarin dose.

Patients taking warfarin need to have their blood checked monthly to see if the drug is working properly. The test is called the PT -- or prothrombin time -- test, which evaluates the blood's ability to clot. The results are measured in seconds and compared with the expected value in healthy people.

The changes to the label will be made by manufacturers of warfarin, the generic version of Coumadin. Bristol-Myers Squibb Co., of Princeton, N.J., is the manufacturer of Coumadin, the FDA said.

More information

For more on warfarin, visit the U.S. National Library of Medicine.

SOURCES: Aug. 16, 2007, teleconference with Janet Woodcock, M.D., deputy commissioner and chief medical officer, U.S. Food and Drug Administration; Larry Les
'/>"/>

0

GOOD

Page: 1 2 3
Related medicine news :

1. WHO Updates Outdated Pediatric Growth Charts
2. A prescription cream for unwanted facial hair
3. Lose Weight With New Wonder Slimming FDA approved Prescription Drug
4. Prescription Drug - Helps People Stop Smoking
5. Misleading Advertisements for Prescription Drugs
6. Patients Pressure Would Result In Overprescription
7. TV drug commercials prompt prescriptions
8. Prescription Drug Use Varies Widely Between States
9. Status of some prescription drugs
10. Abuse of prescription drugs among youths on the rise
11. Does Your Prescription Have An Inappropriate Medicine?

Post Your Comments:

FDA Updates Prescription Guidelines for Blo...(nals may well decide to incorporate gene...),Health