"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
Adequate treatment provisions including epinephrine, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
Children and young adults who are known to be infected with human immunodeficiency viruses but without overt clinical manifestations of immunosuppression may be vaccinated; however, the vaccinees should be monitored closely for vaccine-preventable diseases because immunization may be less effective than for uninfected persons.
Excretion of small amounts of the live attenuated rubella virus from the nose and throat has occurred in the majority of susceptible individuals 7-28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk. However, transmission of the rubella vaccine virus to infants via breast milk has been documented (see Nursing Mothers ).
There are no reports of transmission of live attenuated mumps virus from vaccinees to susceptible contacts.
It has been reported that live attenuated rubella and mumps virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either before or simultaneously with BIAVAX (rubella and mumps virus vaccine live) II.
As for any vaccine, vaccination with BIAVAX (rubella and mumps virus vaccine live) II may not result in seroconversion in 100% of susceptible persons given the vaccine.
Pregnancy Category C
Animal reproduction studies have not been conducted with BIAVAX (rubella and mumps virus vaccine live) II. It is also not known whether BIAVAX (rubella and mumps virus vaccine live) II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, the vaccine should not be administered to pregnant females; furthermore, pregnancy should be avoided for three months following vaccination (see CONTRAINDICATIONS ).
In counseling women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months of vaccination, the physician should be aware of the following: (1) In a 10 year survey involving over 700 pregnant women who received rubella vaccine within 3 months before or after conception, (of whom 189 received the Wistar RA 27/3 strain) none of the newborns had abnormalities compatible with congenital rubella syndrome; and (2) although mumps virus is capable of infecting the placenta and fetus, there is no good evidence that it causes congenital malformations in humans. Mumps vaccine virus also has been shown to infect the placenta, but the virus has not been isolated from the fetal tissues from susceptible women who were vaccinated and underwent elective abortions.
It is not known whether mumps vaccine virus is secreted in human milk. Recent studies have shown that lactating postpartum women immunized with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella. Caution should be exercised when BIAVAX (rubella and mumps virus vaccine live) II is administered to a nursing woman.
This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Biavax Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.