|
|
Magazine: FDA CONSUMER, JULY-AUGUST 1997
Section: UPDATES
FIRST HOME TEST CLEARED FOR BLOOD CLOTTING
Heart patients and others taking the blood-thinning drug Coumadin (warfarin)
to prevent clotting can now test for the drug's effect at home with a
prescription kit cleared by FDA.
Like
other blood thinners, Coumadin is used to treat people with artificial
heart valves, irregular heartbeat, and other conditions that lead to excessive
blood clotting. These drugs have a "narrow" therapeutic range:
Too much blood thinner can cause hemorrhage, while too little can allow
clots to form and obstruct blood vessels, causing stroke or death.
Using
the ProTime Microcoagulation System, a patient pricks a finger to draw
a blood sample and runs the sample through a small, hand-held electronic
device that displays results on a screen.
FDA
previously cleared the test, known as a prothrombin time (PT) test, for
use in doctors' offices, clinics, and nursing homes to check blood coagulation.
The home prescription version will be for use under a doctor's supervision.
Previously,
patients taking Coumadin had a PT test every one or two months during
regular visits to their doctor. With the new kit, they can test themselves
weekly, or as often as their doctor recommends. The system stores the
40 most recent results with a date and time stamp, enabling the doctor
to review and interpret results and adjust the drug if needed. Doctors
can program the appropriate upper and lower blood-clotting ranges for
each patient.
FDA
cleared the device after reviewing data on 84 patients at four clinics.
The patients had the professional laboratory PT test at the clinics and
also tested themselves with the home kit. Both types of tests showed comparable
results.
International Technidyne Corp., Edison, N.J., makes the ProTime Microcoagulation System
*Copyright
of the publication is the property of the publisher and the text may not
be copied without the express written permission of the publisher except
for the inprint of the video screen content or via the print options of
the software. Text is intended solely for the use of the individual user.
Copyright
of "First home test cleared for blood clotting." is the property
of FDA Consumer and its content may not be copied without the copyright
holder's express written permission except for the print or download intended
solely for the use of the individual user. Content provided by EBSCO Publishing.
|
|
|
