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Bristol-Myers Squibb Recalls Mislabeled Anticoagulant Drug

Bottles of the anticoagulant drug labeled as 5mg were found to contain 2.5 mg tablets.

Bristol-Myers Squibb Recalls Mislabeled Anticoagulant Drug

By: Sarah Hand, M.Sc.

Posted on: in News | Drug Safety News

Pharmaceutical company Bristol-Myers Squibb has recalled one lot of 5 mg Eliquis (apixaban) tablets after the batch was identified as being mislabeled. Bottles of the anticoagulant drug labeled as 5mg were found to contain 2.5 mg tablets.

The error was identified after a customer complained about the mislabeled bottle. Wholesale and retail pharmacies across the US could have this batch in stock, which was distributed in February of this year.

“Patients should not stop taking Eliquis without consulting with their physician,” said a press release issued by Bristol-Myers Squibb. “Patients who are prescribed Eliquis 5 mg for an irregular heartbeat (atrial fibrillation) and take an Eliquis 2.5 mg tablet instead, particularly for a prolonged period, would have an increased probability of stroke, a moving blood clot, or death.”

Eliquis is a blood thinner used to decrease the risk of blood clots and stroke in patients with atrial fibrillation and those who have recently undergone hip or knee replacement surgery. Patients prescribed 5mg Eliquis who unknowingly take the 2.5 mg tablets could be at an increased risk of a growing or moving blood clot and stroke.

While underdosing of the anticoagulant could lead to potentially life-threatening side effects, the company said that no illness related to the mislabeled Eliquis have been reported. Fortunately, the two doses of medication show obvious differences including colour, size and share.

The 2.5 mg tablet is yellow and round with the number “893” imprinted on one side, and “2½” on the other side. In contrast, the 5 mg tablet is pink and oval with “894” imprinted on one side and “5” on the other.

“Patient safety is our first priority,” said the press release. “Bristol-Myers Squibb has notified wholesalers and pharmacies to arrange for return and replacement of any recalled product.”

Patients with lot number HN0063 are being encouraged to contact their physician and the Bristol-Myers Squibb Customer Information Center for details on how to exchange the product. They should also report any adverse events they’ve experienced that may be related to taking mislabeled Eliquis.


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