HHS NEWS
U.S. Department of Health and Human Services
P97-9 Food and Drug Administration
FOR IMMEDIATE RELEASE Sharon Snider (301) 443-3285
March 13, 1997 Broadcast Media: (301) 827-3434
Consumer Hotline:(800) 532-4440
FDA CLEARS FIRST HOME TEST FOR BLOOD CLOTTING
The Food and Drug Administration has cleared for marketing
the first home test for use with blood thinning medicine. The
convenient, new test is intended for use by heart patients and
others who are taking the blood thinning drug warfarin (Coumadin)
to prevent clotting.
The ProTime Microcoagulation System, made by International
Technidyne Corp., of Edison, N.J., is a simple finger stick test
in which the user pricks his finger with a needle to draw blood,
then runs the sample through a small, hand-held electronic device
which displays the results on a screen.
The test, known as a prothrombin time (PT) test, is already
cleared by FDA for use in physician offices, clinics and nursing
homes to test for blood coagulation. The new system will now be
available by prescription for home use under a doctor's
supervision.
"People on blood thinning medicine need to be monitored
closely by their doctors to make sure they are getting the right
dose. It is critical that they not get too much or too little,
and the drug level can change easily," said Bruce Burlington,
M.D., director of FDA's Center for Devices and Radiological
Health.
"Home tests will make it easier to do this. They will
permit more frequent testing, allow closer monitoring, and will
enable people to check at any time to see if their blood thinner
is working properly."
Blood thinners are used to treat people with artificial
heart valves, irregular heart beat and other conditions that lead
to excessive blood clotting. These drugs have a narrow
therapeutic range. If the drug level is too high, the patient
can hemorrhage. If it is too low, clots can form and obstruct
blood vessels, causing stroke and even death.
Currently, people taking these drugs are given a PT test
every one or two months during regular visits to their doctor.
With the new home test system, however, they will be able to 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 the results
and adjust the blood thinner accordingly.
The system can be programmed by the doctor with the
appropriate upper and lower blood clotting range for each
patient. The system displays "In Range" if the results are
within the limits and "INR High" or "INR Low" if the results are
too high or too low. If the results are out of range, the
patient is instructed to re-test himself to confirm and then call
the doctor immediately.
FDA's decision to clear the test system for home use was
based on comparison data collected by the manufacturer on 84
patients at four clinics. The patients were tested at the
clinics by health professionals using the professional laboratory
PT test. The patients also tested themselves at home with the
new system. The results proved comparable.
The Pro-time test system has been cleared only for use by
patients taking warfarin. Its accuracy has not been studied with
any other blood thinning drugs.
Alan W Davidson
General Secretary, International Pharmaceutical Federation
a.davidson@fip.nl or visit our web site at
http://www.pharmweb.net/pwmirror/pw9/fip/pharmweb92.html
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