Capping a day of unpleasant news for Abbott Laboratories, the company Friday issued a public warning that incorrect use of its blood glucose meters could lead to inaccurate test results and hyperglycemia.
That followed news earlier that the Food and Drug Administration officially rejected Abbott Laboratories’ application to sell the Xinlay prostate cancer pill, a medicine that was unable to convince the agency’s advisers last month that it could delay progression of the disease.
Because the FDA panel had unanimously rejected Abbott’s application last month, it was no surprise that the agency would follow through with a rejection. Both announcements made by the North Chicago-based firm came after the close of trading on the New York Stock Exchange.
Yet the warning on the meters could be a blow to Abbott’s fast-growing diabetes-care franchise, a division that was expected to generate $1 billion in annual sales this year.
Users of the meters, which are sold under a range of brands including FreeStyle, Precision Xtra, MediSense and Rite Aid, can display their results in one of two standard units of measure, the company said.
Some customers have complained of accidentally switching the units of measure from milligrams per deciliter, the U.S. standard, to millimoles per liter, which is used in other countries. “This could lead to misinterpretation of test results with possible undertreatment and the potential for hyperglycemia,” the company said.
Abbott said it has filed 17 medical device reports in the U.S. related to this issue, and those reports come from a user base of 2.25 million in the U.S. Abbott said consumers can continue to safely use the meters but should verify “that their meter is displaying the correct unit of measure each time they test.” Consumers with questions may call Abbott at 1-800-553-4105.
As for the FDA’s rejection of Xinlay, Abbott said it doesn’t affect a study under way, the company disclosed Friday in a filing with the U.S. Securities and Exchange Commission.
“We are continuing to study Xinlay in an earlier stage of prostate cancer,” Abbott spokeswoman Laureen Cassidy said.
A panel of FDA advisers voted unanimously last month to recommend rejecting the drug, saying Abbott has not yet shown that it will help men dying of advanced prostate cancer. The drug was also shown to increase the risk of heart failure in some patients.
Prostate cancer kills about 30,000 men a year in the U.S. when it spreads in the body, according to the National Institutes of Health’s Web site.
