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Medications
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Recombivax HB and Pregnancy
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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.
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