"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"...
Do not administer ProQuad to individuals with a history of anaphylactic reactions to neomycin. If vaccination with ProQuad is medically necessary for such individuals, they are advised to consult an allergist or immunologist and should receive ProQuad only in settings where anaphylactic reactions can be appropriately managed.
Do not administer ProQuad to individuals with a history of hypersensitivity to gelatin or any other component of the vaccine or following previous vaccination with ProQuad, VARIVAX® (varicella virus vaccine live), or any measles-, mumps-, or rubella-containing vaccine [see DESCRIPTION and WARNINGS AND PRECAUTIONS for exceptions].
Do not administer ProQuad to individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; or to individuals on immunosuppressive therapy (including high-dose systemic corticosteroids) [see DRUG INTERACTIONS]. Vaccination with a live, attenuated vaccine, such as varicella, can result in a more extensive vaccine-associated rash or disseminated disease in individuals on immunosuppressive drugs. ProQuad may be used by individuals who are receiving topical corticosteroids or low-dose corticosteroids, as are commonly used for asthma prophylaxis or in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.
Do not administer ProQuad to individuals with primary and acquired immunodeficiency states, including AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis, pneumonitis, and death as a direct consequence of disseminated measles vaccine virus infection have been reported in severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In addition, disseminated varicella vaccine virus infection has been reported in children with underlying immunodeficiency disorders who were inadvertently vaccinated with a varicella-containing vaccine1.
Do not administer ProQuad to individuals who are pregnant; the possible effects of the vaccine on fetal development are unknown at this time [see Use in Specific Populations].
1. Levy O, et al. Disseminated varicella infection due to the vaccine strain of varicella-zoster virus, in a patient with a novel deficiency in natural killer T cells. J Infect Dis. 188(7):948-53, 2003.
Last reviewed on RxList: 9/12/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Proquad 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.