"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"...
Following routine use of tetanus toxoid (tetanus (tetanus toxoid) toxoid) in the United States (US), the occurrence of tetanus (tetanus toxoid) decreased dramatically from 560 reported cases in 1974 to an average of 50-100 cases reported annually from the mid 1970s through the late 1990s. The case-fatality rate has been relatively constant at approximately 30%. During the years 1982-1998, 52% of reported cases were among persons 60 years of age or older. In the mid to late 1990s, the age distribution of reported cases shifted to a younger age group, in part due to an increased number of cases among injection drug users in California. From 1995-1997, persons 20 to 59 years of age accounted for 60% of all cases, with persons60 years of age or older accounting for only 35%. In the US, tetanus (tetanus toxoid) occurs almost exclusively among unvaccinated or inadequately vaccinated persons.1
In 4% of tetanus (tetanus toxoid) cases reported during 1987 and 1988, no wound or other condition was implicated. Non-acute skin lesions, such as ulcers, or medical conditions such as abscesses, were reported in association with 14% of cases.2
Neonatal tetanus (tetanus toxoid) occurs among infants born under unhygienic conditions to inadequately vaccinated mothers. Vaccinated mothers confer protection to their infants through transplacental transfer of maternal antibody. From 1972 through 1984, 29 cases of neonatal tetanus (tetanus toxoid) were reported in the US.2 Since 1984, only three cases of neonatal tetanus (tetanus toxoid) have been reported in all infants of unvaccinated or inadequately vaccinated mothers.3
Spores of C. tetani are ubiquitous. Serologic tests indicate that naturally acquired immunity to tetanus (tetanus toxoid) toxin does not occur in the US.2 Thus, universal primary vaccination, with subsequent maintenance of adequate antitoxin levels by means of appropriately timed boosters, is necessary to protect all age-groups. Tetanus toxoid (tetanus (tetanus toxoid) toxoid) is a highly effective antigen, and a completed primary series generally induces protective levels of serum antitoxin that persists for 10 or more years.2 In a trial of 26 adults given a booster dose of Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) , 81% of the subjects demonstrated a 2-fold or greater rise in serum antitoxin antibody levels.4 There are no studies of this product used as a primary series.
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
3. CDC. Neonatal Tetanus (tetanus toxoid) Montana, 1998. MMWR 47 (43):928-930, 1998
4. Aventis Pasteur Inc., Data on File 073001
Last reviewed on RxList: 6/6/2006
This monograph has been modified to include the generic and brand name in many instances.
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