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Tetanus Toxoid Side Effects, and Drug Interactions - Tetanus Toxoid USP

Tetanus Toxoid Side Effects, and Drug Interactions - Tetanus Toxoid USP

SIDE EFFECTS

Body System As A Whole

Adverse reactions may be local and include redness, warmth, edema, induration with or without tenderness as well as urticaria, and rash. Malaise, transient fever, pain, hypotension, nausea and arthralgia may develop in some patients after the injection. Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection) may occur, particularly in persons who have received multiple prior boosters.1 On rare occasions, anaphylaxis has been reported following administration of products containing tetanus toxoid. Upon review, a report by the Institute of Medicine (IOM) concluded the evidence established a causal relationship between tetanus toxoid and anaphylaxis.12 Deaths have been reported in temporal association with the administration of tetanus toxoid containing vaccines.

Nervous System

The following neurologic illnesses have been reported as temporally associated with vaccines containing tetanus toxoid: neurological complications 13,14 including cochlear lesion,15 brachial plexus neuropathies,15,16 paralysis of the radial nerve,17 paralysis of the recurrent nerve,15 accommodation paresis, Guillain- Barré syndrome, and EEG disturbances with encephalopathy. The I.M. following review of the reports of neurologic events following vaccination with tetanus toxoid, DT or Td, concluded the evidence favored acceptance of a causal relationship between tetanus toxoid and brachial neuritis and Guillain- Barré syndrome.12,18

Reporting of Adverse Events

Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by health- care providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.7,8,9

Health-care providers also should report these events to the Director of Medical Affairs, Connaught Laboratories, Inc., A Pasteur Mérieux Connaught Company, Route 611, PO Box 187, Swiftwater, PA 18370 or call 1-800-822-2463.

DRUG INTERACTIONS

If passive immunization for tetanus is needed, TIG (Human) is the product of choice. It provides longer protection than antitoxin of animal origin and causes few adverse reactions. The currently recommended prophylactic dose of TIG (Human) for wounds of average severity is 250 units intramuscularly. When a vaccine containing tetanus toxoid is given at the same time as TIG (Human), separate syringes and separate sites should be used. The ACIP recommends the use of only adsorbed toxoid in this situation.1

The vaccine should be administered subcutaneously in patients on anticoagulant therapy.

Immunosuppressive therapies may reduce the response to vaccines (see PRECAUTIONS section).

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