"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
In very rare cases, neurological and neuroparalytical events have been reported in temporal association with administration of RabAvert (see also WARNINGS section). These include cases of hypersensitivity (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections).
The most commonly occurring adverse reactions are injection site reactions, such as injection site erythema, induration and pain; flu-like symptoms, such as asthenia, fatigue, fever, headache, myalgia and malaise; arthralgia, dizziness, lymphadenopathy, nausea, and rash.
A patient's risk of acquiring rabies must be carefully considered before deciding to discontinue vaccination. Advice and assistance on the management of serious adverse reactions for persons receiving rabies vaccines may be sought from the state health department or CDC (see also CONTRAINDICATIONS section).
Local reactions such as induration, swelling and reddening have been reported more often than systemic reactions. In a comparative trial in normal volunteers, Dreesen et al.4 described their experience with RabAvert compared to a HDCV rabies vaccine. Nineteen subjects received RabAvert and 20 received HDCV. The most commonly reported adverse reaction was pain at the injection site, reported in 45% of the HDCV group, and 34% of the RabAvert group. Localized lymphadenopathy was reported in about 15% of each group. The most common systemic reactions were malaise (15 % RabAvert group vs. 25 % HDCV group), headache (10 % RabAvert group vs. 20 % HDCV group), and dizziness (15 % RabAvert group vs. 10 % HDCV group). In a recent study in the USA5, 83 subjects received RabAvert and 82 received HDCV. Again, the most common adverse reaction was pain at the injection site in 80% in the HDCV group and 84% in the RabAvert group. The most common systemic reactions were headache (52% RabAvert group vs. 45% HDCV group), myalgia (53% RabAvert group vs. 38% HDCV group) and malaise (20% RabAvert group vs. 17% HDCV group). None of the adverse events were serious, almost all adverse events were of mild or moderate intensity. Statistically significant differences between vaccination groups were not found. Both vaccines were generally well tolerated.
Uncommonly observed adverse events include temperatures above 38°C (100°F), swollen lymph nodes, pain in limbs and gastrointestinal complaints. In rare cases, patients have experienced severe headache, fatigue, circulatory reactions, sweating, chills, monoarthritis and allergic reactions; transient paresthesias and one case of suspected urticaria pigmentosa have also been reported.
Observed During Clinical Practice
(See WARNINGS AND PRECAUTIONS)
The following adverse reactions have been identified during post approval use of RabAvert. Because these reactions are reported voluntarily from a population of uncertain size, estimates of frequency cannot be made. These events have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to RabAvert, or a combination of these factors:
Cardiac: Palpitations, hot flush
Local: Extensive limb swelling
The use of corticosteroids to treat life-threatening neuroparalytic reactions may inhibit the development of immunity to rabies (see PRECAUTIONS: DRUG INTERACTIONS).
Once initiated, rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic adverse reactions to rabies vaccine. Usually such reactions can be successfully managed with anti-inflammatory and antipyretic agents.
Reporting Of Adverse Events
Adverse events should be reported by the health care provider or patient to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Report forms and information about reporting requirements or completion of the form can be obtained from VAERS by calling the toll-free number 1-800-822-79671. In the USA, such events can be reported to the Professional Services department, Novartis Vaccines and Diagnostics, Inc.: phone: 1-800-244-7668.
Read the Rabavert (rabies vaccine) Side Effects Center for a complete guide to possible side effects
Radiation therapy, antimalarials, corticosteroids, other immunosuppressive agents and immunosuppressive illnesses can interfere with the development of active immunity after vaccination, and may diminish the protective efficacy of the vaccine. Preexposure vaccination should be administered to such persons with the awareness that the immune response may be inadequate. Immunosuppressive agents should not be administered during postexposure therapy unless essential for the treatment of other conditions. When rabies postexposure prophylaxis is administered to persons receiving corticosteroids or other immunosuppressive therapy, or who are immunosuppressed, it is important that a serum sample on day 14 (the day of the fourth vaccination) be tested for rabies antibody to ensure that an acceptable antibody response has been induced1.
HRIG must not be administered at more than the recommended dose, since active immunization to the vaccine may be impaired.
No data are available regarding the concurrent administration of RabAvert with other vaccines.
1. CDC. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Human Rabies Prevention - United States, 1999. Morbidity and Mortality Weekly Report Recommendations and Report, January 8, 1999, Vol.48, RR-1, pg 1.1-21.
4. Dreesen DW, et al. Two-year comparative trial on the immunogenicity and adverse effects of purified chick embryo cell rabies vaccine for preexposure immunization. Vaccine. 1989; 7: 397-400.
5. Dreesen, DW. Investigation of antibody response to puified chick embryo cell tissue culture vaccine (PCECV) or human diploid cell culture vaccine (HDCV) in healthy volunteers. Study synopsis 7USA401RA, September 1996 - December 1996 (unpublished).This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/22/2014
Additional Rabavert 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.