Characteristics of Patients for Whom Benznidazole Was Released Through the CDC-Sponsored Investigational New Drug Program for Treatment of Chagas Disease - United States, 2011-2018.

Chagas disease (also known as American trypanosomiasis) is caused by the protozoan parasite Trypanosoma cruzi (1,2). Vectorborne transmission via skin or mucosal contact with the feces of infected triatomine bugs mainly occurs in rural areas of Latin America but has been reported in the southern United States (3). The parasite also is transmissible congenitally and via blood transfusion, organ transplantation, and accidental laboratory exposures. The two drugs used for treating Chagas disease are benznidazole and nifurtimox (1,2), which have been used in Latin America since the 1970s and 1960s, respectively. In the absence of commercially available drugs approved by the Food and Drug Administration (FDA), benznidazole and nifurtimox have been available exclusively through CDC, under Investigational New Drug (IND) treatment protocols. On August 29, 2017, FDA approved a benznidazole product (Chemo Research, SL, in care of Exeltis*) for treatment of Chagas disease (4), which became commercially available on May 14, 2018. Therefore, effective May 14, 2018, benznidazole is no longer available through the CDC-sponsored IND program. This report summarizes selected characteristics of patients for whom CDC released benznidazole through that program from October 2011, when the IND went into effect, until mid-May 2018. The majority of the 365 patients included in intention-to-treat analyses were chronically infected adults who were born and became infected in Latin America. Physician requests for benznidazole should now be directed to the drug company Exeltis.† The CDC-sponsored IND for nifurtimox remains in effect to provide an alternative therapeutic option to benznidazole when clinically appropriate. CDC will continue to provide reference diagnostic testing for T. cruzi infection and teleconsultative services regarding Chagas disease.

U.S. Compounding Pharmacy-Related Outbreaks, 2001-2013: Public Health and Patient Safety Lessons Learned.

OBJECTIVES: Pharmacy-compounded sterile preparations (P-CSPs) are frequently relied upon in U.S. health care but are increasingly being linked to outbreaks of infections. We provide an updated overview of outbreak burden and characteristics, identify drivers of P-CSP demand, and discuss public health and patient safety lessons learned to help inform prevention. METHODS: Outbreaks of infections linked to contaminated P-CSPs that occurred between January 1, 2001, and December 31, 2013, were identified from internal Centers for Disease Control and Prevention reports, Food and Drug Administration drug safety communications, and published literature. RESULTS: We identified 19 outbreaks linked to P-CSPs, resulting in at least 1000 cases, including deaths. Outbreaks were reported across two-thirds of states, with almost one-half (8/19) involving cases in more than 1 state. Almost one-half of outbreaks were linked to injectable steroids (5/19) and intraocular bevacizumab (3/19). Non-patient-specific compounding originating from nonsterile ingredients and repackaging of already sterile products were the most common practices associated with P-CSP contamination. Breaches in aseptic processing and deficiencies in sterilization procedures or in sterility/endotoxin testing were consistent findings. Hospital outsourcing, preference for variations of commercially available products, commercial drug shortages, and lower prices were drivers of P-CSP demand. CONCLUSIONS: Recognized outbreaks linked to P-CSPs have been most commonly associated with non-patient-specific repackaging and nonsterile to sterile compounding and linked to lack of adherence to sterile compounding standards. Recently enhanced regulatory oversight of compounding may improve adherence to such standards. Additional measures to limit and control these outbreaks include vigilance when outsourcing P-CSPs, scrutiny of drivers for P-CSP demand, as well as early recognition and notification of possible outbreaks.