UPDATE 1-Bristol-Myers recalls Coumadin samples

Wed Jun 30, 2010 3:14pm EDT

* Recall due to variation in drug stabilizer isopropanol

* 144,700 10-tablet packages of 1 mg tablets affected

* Only samples drugs recalled (Adds background, paragraph five)

CHICAGO, June 30 (Reuters) - Bristol-Myers Squibb Co (BMY.N) has recalled some of its samples of Coumadin, a popular blood thinner, because of a variation in an ingredient that stabilizes the active drug.

A spokeswoman for the company said Wednesday that eight lots, or 144,700 samples, each of which contained 10 tablets, have been recalled. The affected lots were only distributed as samples, she said.

In a letter to doctors dated June 25, the drugmaker said it was recalling the 1 mg tablets of blister-packed samples of Coumadin -- the name brand for Warfarin -- that it provides to doctors to give to patients.

The letter noted a variation in isopropanol, which helps to stabilize the active ingredient in Coumadin.

The drug is used to prevent blood clots from forming or growing larger and is prescribed to patients with certain types of irregular heartbeat, with prosthetic heart valves, and those who have suffered heart attacks. It is also used to treat or prevent venous thrombosis, a swelling and blood clot in a vein, and pulmonary embolism, a blood clot in the lung.

"We monitor our patients on Coumadin closely and if the stabilizer is not consistent, it can be very dangerous. Coumadin is prescribed to treat or prevent blood clots, so if there's too little then there's a risk of clots which could lead to heart attack or stroke, and if there's too much, there's an increased risk of bleeding," said Dr. Micah Eimer, a cardiologist in suburban Chicago.

"There are serious life-threatening consequences if (isopropanol) is too high or too low," he added. (Reporting by Debra Sherman, editing by Gerald E. McCormick)

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