"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
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.2 On rare occasions, anaphylaxis has been reported following administration of products containing tetanus (tetanus toxoid) toxoid. Upon review, a report by the Institute of Medicine (IOM) concluded the evidence established a causal relationship between tetanus toxoid (tetanus (tetanus toxoid) toxoid) and anaphylaxis.17 Deaths have been reported in temporal association with the administration of tetanus toxoid (tetanus (tetanus toxoid) toxoid) -containing vaccines.
The following neurologic illnesses have been reported as temporally associated with vaccines containing tetanus toxoid (tetanus (tetanus toxoid) toxoid) : neurological complications 18,19 including cochlear lesion, 20 brachial plexus neuropathies, 20,21 paralysis of the radial nerve, 22 paralysis of the recurrent nerve, 20 accommodation paresis, Guillain-Barré syndrome, and EEG disturbances with encephalopathy. The IOM, following review of the reports of neurologic events following vaccination with tetanus toxoid (tetanus (tetanus toxoid) toxoid) , DT or Td, concluded the evidence favored acceptance of a causal relationship between tetanus toxoid (tetanus (tetanus toxoid) toxoid) and brachial neuritis and GBS.17,23
Reporting of Adverse Events
The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services.11-13 Reportable events include those listed in the Act for each vaccine and events such as anaphylaxis or anaphylactic shock within 7 days, brachial neuritis within 28 days; any acute complication or sequela (including death) of an illness, 5 disability, injury, or condition referred to above, or any events that would contraindicate further doses of vaccine, according to this Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) for Booster Use Only package insert.
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 1-800-822-7967.11-13
Health-care providers also should report these events to the Pharmacovigilance Department, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.
Read the Tetanus (tetanus toxoid) Side Effects Center for a complete guide to possible side effects »
If passive immunization for tetanus (tetanus toxoid) 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 (tetanus (tetanus toxoid) 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.2
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
12. CDC. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37:197-200, 1988
17. Institute of Medicine. Adverse events associated with childhood vaccines. Evidence Bearing on Causality. National Academy Press, Washington, DC, 1994
18. Rutledge SL, et al. Neurologic complications of immunizations. J Pediatr 109:917-924, 1986
19. Schlenska GK. Unusual neurological complications following tetanus toxoid (tetanus (tetanus toxoid) toxoid) administration. J Neurol 215:299-302, 1977
20. Wilson GS. The Hazards of Immunization. Allergic manifestations:post-vaccinal neuritis. pp 153-156, 1967
23. Pollard JD, et al. Relapsing neuropathy due to tetanus toxoid (tetanus (tetanus toxoid) toxoid) :report of a case. J Neurol Sci 37:113-125, 1978
Last reviewed on RxList: 6/6/2006
This monograph has been modified to include the generic and brand name in many instances.
Additional Tetanus 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.
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