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# Baraclude Label Updated with Safety Study Results
- URL: https://www.fdaweb.com/baraclude-label-updated-with-safety-study-results/
- Published: 2019-11-08T12:00:00.000Z
- Updated: 2026-09-14T15:52:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145460

FDA says it has approved changes to the labeling for Bristol-Myers Squibb’s Baraclude (entecavir) tablet and oral solution to include data from a post-marketing study to assess the major clinical outcomes of death, progression of liver disease, and cancer in a broad population of HBV-infected patients using entecavir compared to standard of care over a period of 5-10 years of follow-up. An agency [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=273923&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=22768872587f4dc8b241d7e6195550cc&elqaid=10194&elqat=1&ref=fdaweb.com) says the study showed that Baraclude was not significantly associated with an increased risk of malignant neoplasms compared to other standard of care HBV (hepatitis B virus) nucleos(t)ides. The data also showed that long-term Baraclude use was not associated with a lower occurrence of HBV disease progression or a lower rate of death overall compared to other HBV nucleos(t)ides.