apixaban FDA Alerts
The FDA Alert(s) below may be specifically about apixaban or relate to a group or class of drugs which include apixaban.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for apixaban
Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets
Jun 13, 2017
Audience: Cardiology, Pharmacy
ISSUE: Bristol-Myers Squibb Company is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets.
BACKGROUND: Eliquis tablets are indicated to reduce the risk of stroke and blood clots in people who have atrial fibrillation; it also treats blood clots in the veins of your legs or lungs as well as reduces the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.
RECOMMENDATION: Patients should not stop taking Eliquis without consulting with their physician. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/13/2017- Company Announcement–Bristol Myers Squibb ]