By Bruce Japsen |
The U.S. Food and Drug Administration has approved an Abbott
Laboratories’ blood sugar test the agency hopes will eliminate
inaccurate results in certain diabetic patients taking other
medications.

The FDA has been working with the makers of certain glucose-testing
strips from Abbott, Roche Diagnostics and other companies to prevent a
potentially deadly problem the agency said for years put at risk
diabetic patients who received drugs containing certain sugars other
than glucose.The FDA said certain dialysis and other biologic drugs
contain “non-glucose sugars,” which can falsely elevate results and
increase the risk of overdose from insulin.

In giving an okay to Abbott’s new Freestyle Lite test strips that can be used with Freestyle Lite and Freestyle Freedom Lite meters, the FDA said it has cleared products that measure glucose without measuring other sugars that created falsely high glucose levels. The FDA said it expects to approve similar products from other companies soon but the agency would not elaborate on the status of those approvals.

The Abbott product approval is “the first in a successful effort that has been ongoing for several years,” said Courtney Harper, director of the FDA’s division of chemistry and toxicology devices. “We pushed the companies to move forward.”

The FDA said the incidents of injuries was rare. From 1997 to 2009, the FDA said it received 13 reports of deaths and several hundred reports of patients who slipped into comas who had used the test strips and were on drug products or therapies that contained certain drugs other than glucose.

Harper said the FDA worked with Abbott and other companies to make fixing the tests a high priority in order to speed the approval process she said was completed two years ahead of schedule. “We put forth extra resources to review their data in real-time so we could expedite the review process,” Harper said.

Abbott said the new FreeStyle Lite test strips do not use the GDH-PQQ enzyme, which the company said can be “affected by common non-glucose sugars.”

“The new FreeStyle Lite test strips represent Abbott’s latest success in delivering innovative products for people living with diabetes,” said Heather Mason, senior vice president, Abbott Diabetes Care. “By minimizing interference, Abbott is delivering on what patients and health care professionals demand in diabetes care.”