Freeze-dried Human Anti-Tetanus Immunoglobulin(Takeda)

Thrombotic events (TEs) are rare serious complications following administration of hyperimmune globulin (HIG) products. Our retrospective claims‐based study assessed occurrence of same‐day TEs following administration of HIGs during 2008–2011 and examined potential risk factors using HealthCore's Integrated Research Database (HIRDSM) and laboratory testing of products' procoagulant Factor XIa activity by U.S. Food and Drug Administration. Multivariable regression was used to estimate same‐day TE risk for different products. Of 101,956 individuals exposed to 23 different HIG product groups, 86 (0.84 per 1,000 persons) had a TE diagnosis code (DC) recorded on the same day as HIG administration. Unadjusted same‐day TE DC rates (per 1,000 persons) ranged from 0.4 to 148.9 for different products. GamaSTAN S/D IG >10 cc had statistically significantly higher same‐day TE DC risk compared to Tetanus IG (OR = 57.57; 95% CI = 19.72–168.10). Increased TE risk was also observed with older age (≥45 years), prior thrombotic events, and hypercoagulable state(s). Laboratory investigation identified elevated Factor XIa activity for GamaSTAN S/D, HepaGam B, HyperHep B S/D, WinRho SDF, HyperRHO S/D full dose, and HyperTET S/D. Our study, for the first time, identified increase in the same‐day TE DC risk with GamaSTAN S/D IG >10 cc and suggests potentially elevated TE risk with other HIGs. Am. J. Hematol. 88:1035–1040, 2013. © 2013 Wiley Periodicals, Inc.

We report herein on a rare case of tetanus originating from ulcerated breast cancer. A 60-year-old homeless woman was admitted to our hospital because of lockjaw. On admission, a physical examination revealed tachypnea, trismus, opisthotonus and an ulcerated right breast. There was no other skin soft tissue damage. A diagnosis of tetanus was entertained from the lockjaw and opisthotonus. Tetanus globulin, tetanus toxoid, penicillin and respiratory support were initiated. Later, a right total mastectomy was performed, and the diagnosis of breast cancer was made, however, gram positive bacilli were not detected and Clostridiuum tetani (C. tetani) was not cultured. It is conceivable that the ulcerated breast was contaminated with C. tetani due to the patients living conditions.