"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"...
Intramuscular injections should be given with great care in patients suffering from thrombocytopenia or other coagulation disorders. In this situation, subcutaneous administration of Tetanus (tetanus toxoid) Toxoid may be advisable.
A routine booster should not be given more frequently than every ten years. (This guideline should not preclude wound management considerations.)
Persons who experienced Arthus-type hypersensitivity reactions or temperature greater than 39.4°C (103°F) after a previous dose of a tetanus toxoid (tetanus (tetanus toxoid) toxoid) -containing preparation usually have very high serum tetanus (tetanus toxoid) antibody levels and should not be given even emergency doses of tetanus toxoid (tetanus (tetanus toxoid) toxoid) -containing preparation more frequently than every 10 years, even if they have a wound that is neither clean nor minor.9
Care is to be taken by the health-care provider for the safe and effective use of Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) .
There is an increased incidence of local and systemic reactions to booster doses of tetanus toxoid (tetanus (tetanus toxoid) toxoid) when given to previously immunized persons. (Refer to DOSAGE AND ADMINISTRATION section for timing of booster injections.) Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. The physician should have a current knowledge of the literature concerning the use of the vaccine under consideration, including the nature of the adverse reactions that may follow its use. The patients medical history should be reviewed with respect to possible sensitivity and any previous adverse reactions to the vaccine or similar vaccines, possible sensitivity to dry natural latex rubber, previous immunization history, and current health status (see CONTRAINDICATIONS section).
Persons who have a history of Guillain-Barré syndrome (GBS) may be at increased risk of recurrent GBS after subsequent doses of Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) vaccines. However, in a study in which an estimated 1.2 million doses of tetanus (tetanus toxoid) -containing toxoid were administered to persons >18 years of age, two cases of GBS were expected by chance alone during the 6 weeks after vaccination, and only one case was reported. This finding suggests that the risk of GBS after administration of tetanus toxoid (tetanus (tetanus toxoid) toxoid) is extremely low. The decision to administer tetanus (tetanus toxoid) -toxoid-containing vaccine to persons who have had GBS within 6 weeks after receiving tetanus toxoid (tetanus (tetanus toxoid) toxoid) should be based on the benefits of subsequent vaccination and the risk of the recurrence of GBS.9
The expected immune response to Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) may not be obtained in immunosuppressed patients. Administration of Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) is not contraindicated in patients with HIV infection.10
Immunosuppressive therapies including radiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic drugs may reduce the immune response to vaccines. Therefore, routine vaccination should be deferred, if possible, while patients are receiving such therapy.2 If Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) has been administered to persons receiving immunosuppressive therapy, or having an immunodeficiency disorder, an adequate antibody response may not be obtained.5 When possible, immunosuppressive treatment should be interrupted when immunization is required due to a tetanus (tetanus toxoid) -prone wound.
It is advisable to use DT (For Pediatric Use 6 years of age and younger) or Td (For Adult Use 7 years of age and older) in wound prophylaxis instead of tetanus toxoid (tetanus (tetanus toxoid) toxoid) alone in order to maintain adequate levels of diphtheria immunity.5
A separate, sterile syringe and needle or a sterile disposable unit must be used for each patient to prevent transmission of hepatitis or other infectious agents from person to person. Needles should not be recapped and should be properly disposed.
Caution: The stopper of the vial contains dry natural latex rubber, that may cause allergic reactions.
No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility.
REPRODUCTIVE STUDIES PREGNANCY CATEGORY C
Adequate immunization by routine boosters in non-pregnant women of child-bearing age can obviate the need to vaccinate women during pregnancy (see DOSAGE AND ADMINISTRATION section).
Animal reproduction studies have not been conducted with Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) . The risk to the fetus from tetanus toxoid (tetanus (tetanus toxoid) toxoid) is unknown. The ACIP recommends that an appropriate tetanus toxoid (tetanus (tetanus toxoid) toxoid) -containing preparation be given to inadequately immunized pregnant women because it affords protection against neonatal tetanus (tetanus toxoid) .10 Waiting until the second trimester is a reasonable precaution to minimize any theoretical teratogenic concern.5
It has been reported that Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) administered to pregnant women prevents neonatal tetanus (tetanus toxoid) in newborns.14,15 However, the data reported on the safety of Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) when so used is inconclusive because the incidence of neonatal deaths in New Guinea was significantly higher than in the US.A prospective study in the US has not been done to confirm these reports.14
Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) does not affect the safety of mothers who are breastfeeding or their infants. Breastfeeding does not adversely affect immune response and is not a contraindication for vaccination.10
SAFETY AND EFFECTIVENESS OF TETANUS TOXOID (tetanus (tetanus toxoid) toxoid) IN INFANTS BELOW THE AGE OF SIX WEEKS HAS NOT BEEN ESTABLISHED. HOWEVER, THIS VACCINE IS NOT INDICATED FOR CHILDREN UNDER 7 YEARS OF AGE.
Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) should only be used in geriatric patients known to have received a primary series (at least 2 doses) of tetanus (tetanus toxoid) -containing vaccine, since many such persons have no prior immunity.16 Clinical studies of Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
2. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, Tetanus (tetanus toxoid) , and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 40:No. RR-10, 1991
5. Report on the Committee of Infectious Diseases, ed 25. Elk Grove Village, IL. American Academy of Pediatrics, 2000
9. CDC. Update:Vaccine Side Effects, Adverse Reactions, Contraindications, and Precautions (ACIP). MMWR 45:No. RR-12, 1996
10. ACIP. General recommendations on immunization. MMWR 43:No. RR-1, 1994
15. Newell KW, et al. The use of toxoid for the prevention of tetanus (tetanus toxoid) neonatorum. Bull WHO 35:863-871, 1966
16. Ruben FL, et al. Antitoxin responses in the elderly to tetanus (tetanus toxoid) -diphtheria (TD) immunization. Am J Epidemiol 108:145-149, 1978This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/6/2006
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