While a vote on the hepatitis B vaccine is underway comes a report on a medication that helps "keep [the virus] from reproducing and causing more liver damage."
A recall update has been published regarding a hepatitis B medication. The news comes as the Centers for Disease Control and Prevention (CDC) convenes to vote on updated guidelines for childhood hepatitis B, Covid-19, and MMRV (measles, mumps, rubella, and varicella) vaccinations.
The recall affects two lots totaling 8,784 bottles of one-milligram (1 mg) Entecavir tablets manufactured by Zydus Lifesciences, reportedly distributed nationwide in 30-tablet bottles. According to the Mayo Clinic, this antiviral medication is used to treat liver infection caused by hepatitis B. “This medicine will not cure the hepatitis B virus, but it will keep it from reproducing and causing more liver damage,” Mayo explains.
According to a notice from the U.S. Food & Drug Administration, the recall was first initiated September 4 after authorities found evidence of what they report as “Failed Impurity/Degradation Specifications.” The National Institute of Health has noted that “chemical and physical changes of active pharmaceutical ingredients … can affect both the safety and efficacy of drugs.” Standards for the manufacturing process are intended to control for those changes.
This week on September 18, the same day the CDC panel voted to restrict MMRV vaccines in children under four and postponed its decision on hepatitis B shots for newborn infants, the FDA announced a Class II designation on this recall. This means the federal agency defines this as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The recalled pills bear the expiration date November 30, 2025, as well as the following lot numbers:
- Lot E309377: 4,440 bottles
- Lot E309376: 4,344 bottles
There is no cure for hepatitis B. While acute hepatitis is rarely fatal, the Hepatitis B Foundation warns that chronic hep B cases lead to thousands of deaths each year in the United States. The CDC further notes that between 15% and 25% of people with chronic hep B infection will “develop chronic liver disease, including cirrhosis, liver failure, or liver cancer.”
Young children are among those at greatest risk of developing chronic illness—the CDC states: “About 9 in 10 infants who become infected go on to develop lifelong, chronic infection. The risk goes down as a child gets older. About 1 in 3 children who get infected before age 6 will develop chronic hepatitis B,” adding: “The best way to prevent HBV infection is by getting vaccinated.”
If you have the affected pills in your possession, it is likely advisable not to stop taking them abruptly, as the Mayo Clinic warns: “Liver disease may become worse if treatment with Entecavir is stopped.” Speak immediately with your doctor or pharmacist about replacing your prescription with an alternative.
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