A packaging error has prompted Bristol-Myers Squibb to recall one lot of the blood thinner Eliquis (apixaban) 5 milligram (mg) tablets. It was discovered that one of the bottles in the lot contained the 2.5mg tablets instead of the labeled 5mg tablets.
The recall only affects Eliquis 5mb tablets in 60-count bottles imprinted with the Lot# HN0063 and the expiration date of September 2019. The two tablet strengths have distinct differences in appearance, which may indicate to the user that he is taking the wrong pill. But if a patient fails to notice this difference, he may be at risk for taking the wrong dose, which can increase his risk of developing a stroke, deep vein thrombosis, pulmonary embolism, and/or systemic thromboembolism (blood clot) due to lower-than-intended dosage.
At this time, there have been no adverse events reported related to the issue involved in this recall. Any side effects experienced while taking this medication should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Eliquis is in a new class of blood thinners known as factor Xa inhibitors. It is used to prevent strokes in patients with the heart rhythm abnormality atrial fibrillation. It is also used to prevent and treat deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement therapy. Other drugs in this class include Xarelto, manufactured by Johnson & Johnson’s Janssen Pharmaceuticals and Bayer.
Both Eliquis and Xarelto side effects include serious bleeding events including gastrointestinal bleeds and brain bleeds. There is currently no antidote available to reverse the blood thinning effects of these drugs in the event of a bleeding emergency.