Bristol-Myers Squibb recalls mislabeled Eliquis medications

Dive Brief:

  • Bristol-Myers Squibb is voluntarily recalling one lot of Eliquis 5 mg tablets from wholesale and retail pharmacies, after a consumer complaint stated a bottle labeled as Eliquis 5 mg contained 2.5 mg tablets.
  • The lot in question had been distributed nationwide in February of this year. The tablets are different in shape, size, color and markings. 
  • Patients prescribed Eliquis 5 mg but take 2.5 mg for a prolonged period would be at an increased risk of stroke, moving blood clots or death, Bristol-Myers Squibb warned.

Dive Insight:

No injuries or adverse events have been reported from patients who received the mislabeled tablets.

The recall is voluntary, and Bristol-Myers Squibb has notified wholesalers and pharmacies to arrange for return and replacement of the recalled medications. The company has also urged patients who have the mislabeled drug to call their physician or the Bristol-Myers Squibb information center.

The 5 mg dose comes in pink, oval tablets marked with "5" and "894" on opposing sides, while the 2.5 mg dose is yellow, round and marked with "2 1/2" and "893." 

Patients on Eliquis with deep vein thrombosis and pulmonary embolism who are undertreated are at a higher risk for potentially life-threatening adverse events from a growing or moving blood clot. Yet, it’s also possible that these symptoms could be reversed by treatment.

Patients with atrial fibrillation who are prescribed 5 mg Eliquis, but take 2.5 mg Eliquis instead — particularly those who are on the mislabeled drug for an extended time — could experience a stroke or moving blood clot that can result in death.

Eliquis tablets are approved to reduce the risk of stroke and blood clots in those with atrial fibrillation, and for treatment of blood clots in the legs and lungs, including clots sustained by patients who have just had hip or knee surgery. 

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Filed Under: Regulatory / Compliance Manufacturing
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