It is unclear if Recombivax HB (hepatitis B vaccine) is safe for use during pregnancy. In some cases, a healthcare provider may recommend Recombivax HB for a pregnant woman if she is at high risk of contracting hepatitis B. The vaccine is not expected to cause any serious fetal problems, but until more research is done, it's impossible to say if the product is completely safe.
Is Recombivax HB Safe While Pregnant?
Recombivax HB® (hepatitis B vaccine) is approved to prevent hepatitis B. It is licensed for all age ranges. At this time, it is uncertain whether this vaccine is safe for use during pregnancy. However, in some situations, the potential benefits of using Recombivax HB when pregnant might outweigh the possible risks.
What Is Pregnancy Category C?
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
The effects of Recombivax HB on a developing fetus are unknown. It is not expected to cause significant or serious problems. However, because the vaccine has not been adequately studied in pregnant women, the possibility of problems cannot be ruled out.
A healthcare provider may advise a pregnant woman to get vaccinated with Recombivax HB if the potential benefits outweigh the risks. For instance, the vaccine may be recommended to a pregnant woman who is at high risk for contracting hepatitis B. Be sure to discuss the potential benefits and risks pertaining to Recombivax HB and pregnancy with your doctor as they pertain to your unique situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Centers for Disease Control and Prevention (CDC). Vaccine information statement: hepatitis B vaccine (7/18/07). CDC Web site. Available at: http://www.cdc.gov/vaccines/Pubs/vis/downloads/vis-hep-b.pdf. Accessed September 2, 2009.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 8th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2008.
National Library of Medicine (US). Drugs and Lactation Database (LactMED). NLM Web site. Available at: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT. Accessed September 2, 2009.
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