Type F Infant Botulism: Investigation of Recent Clusters and Overview of This Exceedingly Rare Disease.

From 1976 to 2016, neurotoxigenic Clostridium baratii type F caused 18 (<0.5%) reported US infant botulism cases. Six cases occurred during 2012-2013; no common source was identified. Type F infant botulism mostly occurs in very young infants and typically presents more rapidly and severely than illness caused by types A and B botulinum neurotoxin.

Comparing Characteristics of Sporadic and Outbreak-Associated Foodborne Illnesses, United States, 2004-2011.

Outbreak data have been used to estimate the proportion of illnesses attributable to different foods. Applying outbreak-based attribution estimates to nonoutbreak foodborne illnesses requires an assumption of similar exposure pathways for outbreak and sporadic illnesses. This assumption cannot be tested, but other comparisons can assess its veracity. Our study compares demographic, clinical, temporal, and geographic characteristics of outbreak and sporadic illnesses from Campylobacter, Escherichia coli O157, Listeria, and Salmonella bacteria ascertained by the Foodborne Diseases Active Surveillance Network (FoodNet). Differences among FoodNet sites in outbreak and sporadic illnesses might reflect differences in surveillance practices. For Campylobacter, Listeria, and Escherichia coli O157, outbreak and sporadic illnesses are similar for severity, sex, and age. For Salmonella, outbreak and sporadic illnesses are similar for severity and sex. Nevertheless, the percentage of outbreak illnesses in the youngest age category was lower. Therefore, we do not reject the assumption that outbreak and sporadic illnesses are similar.

Infectious Dose of Listeria monocytogenes in Outbreak Linked to Ice Cream, United States, 2015.

The relationship between the number of ingested Listeria monocytogenes cells in food and the likelihood of developing listeriosis is not well understood. Data from an outbreak of listeriosis linked to milkshakes made from ice cream produced in 1 factory showed that contaminated products were distributed widely to the public without any reported cases, except for 4 cases of severe illness in persons who were highly susceptible. The ingestion of high doses of L. monocytogenes by these patients infected through milkshakes was unlikely if possible additional contamination associated with the preparation of the milkshake is ruled out. This outbreak illustrated that the vast majority of the population did not become ill after ingesting a low level of L. monocytogenes but raises the question of listeriosis cases in highly susceptible persons after distribution of low-level contaminated products that did not support the growth of this pathogen.

Long-term comparison of antibiotic resistance in Vibrio cholerae O1 and Shigella species between urban and rural Bangladesh.

From 2000 to 2012, Vibrio cholerae O1 and Shigella species isolates from urban Dhaka and rural Matlab were tested for resistance to all clinically relevant antibiotics in Bangladesh. Resistances in urban and rural Bangladesh tended to rise and fall together, especially a few years after the introduction of new resistance.

Haff disease associated with consumption of buffalofish (Ictiobus spp.) in the United States, 2010-2020, with confirmation of the causative species.

BACKGROUND: In the United States, buffalofish (Ictiobus spp.) are sporadically associated with sudden onset muscle pain and weakness due to rhabdomyolysis within 24 h of fish consumption (Haff disease). Previous genetic analyses of case-associated samples were unable to distinguish the three species of buffalofish that occur in the US, Ictiobus cyprinellus (bigmouth buffalo), Ictiobus bubalus (smallmouth buffalo), and Ictiobus niger (black buffalo). METHODS: Ten events were investigated between 2010 and 2020 and demographic and clinical information was collected for 24 individuals. Meal remnants were collected from 5 of 10 events with additional associated samples (n = 24) collected from another five of 10 events. Low-coverage whole-genome sequencing (genome skimming) was used to identify meal remnants. RESULTS: Patients (26-75 years of age) ranged from 1-4 per event, with 90% involving ≥2 individuals. Reported symptoms included muscle tenderness and weakness, nausea/vomiting, and brown/tea-colored urine. Median incubation period was 8 h. Ninety-six percent of cases were hospitalized with a median duration of four days. The most commonly reported laboratory finding was elevated creatine phosphokinase and liver transaminases. Treatment was supportive including intravenous fluids to prevent renal failure. Events occurred in California (1), Illinois (2), Louisiana (1), New York (1), Mississippi (1), Missouri (2), New Jersey (1), and Texas (1) with location of harvest, when known, being Illinois, Louisiana, Mississippi, Missouri, Texas, and Wisconsin. Meal remnants were identified as I. bubalus (n = 4) and I. niger (n = 1). Associated samples were identified as I. bubalus (n = 16), I. cyprinellus (n = 5), and I. niger (n = 3). DISCUSSION: Time course, presentation of illness, and clinical findings were all consistent with previous domestic cases of buffalofish-associated Haff disease. In contrast to previous reports that I. cyprinellus is the causative species in US cases, data indicate that all three buffalofish species are harvested but I. bubalus is most often associated with illness.

Hepatotoxicity due to hydroxycut: a case series.

OBJECTIVES: Muscletech Hydroxycut (Iovate Health Sciences Research, Oakville, Ontario, Canada) was a popular weight-loss supplement that was recalled by the manufacturer in May 2009 on the basis of reports of hepatotoxicity associated with this supplement. We sought to characterize the clinical presentation of Hydroxycut-associated liver injury and to adjudicate these cases for causal association with Hydroxycut. METHODS: We assessed the causality and grading of severity of liver injury using methodology developed by the Drug-Induced Liver Injury Network (DILIN) study. RESULTS: Eight patients who developed liver injury after taking Hydroxycut treated at different medical centers were identified. All were hospitalized, and three of eight patients required liver transplantation. Nine other cases with adequate clinical information were obtained from the FDA MedWatch database, including one fatal case of acute liver failure. Usual symptoms were jaundice, fatigue, nausea, vomiting, and abdominal pain. Most patients exhibited a hepatocellular pattern of injury. Adjudication for causality revealed eight cases as definite, five highly likely, two probable, and two were considered to be possible. CONCLUSIONS: Hydroxycut has been clearly implicated as a cause for severe liver injury that may lead to acute liver failure and death. Weight-loss supplements represent a class of dietary supplements that should be regarded as capable of causing severe hepatic toxicity when the usual causes of identified liver injury cannot be otherwise elucidated.

Analysis of tomato and jalapeño and Serrano pepper imports into the United States from Mexico before and during a National Outbreak of Salmonella serotype Saintpaul infections in 2008.

Case-control studies conducted during a multistate outbreak of Salmonella enterica serotype Saintpaul infections in 2008 revealed associations between illness and the consumption of jalapeño peppers, Serrano peppers, and tomatoes. Traceback investigations of implicated jalapeño and Serrano peppers led to farms in Tamaulipas and Nuevo León, Mexico. We conducted a novel analysis of a U.S. Food and Drug Administration database of tomatoes and jalapeño and Serrano peppers imported from Mexico during the first half of 2008 to describe the temporal and spatial flow of these items into the United States. Shipments of all three produce items followed a south-to-northwest corridor; 87% of peppers and 97% of tomatoes produced in Mexican states located west of the Sierra Madre Occidental were transported to ports in California and Arizona, and 90% of peppers and 100% of tomatoes produced in states east of the Sierra Madre Occidental were transported to ports east of Arizona. We found a significant correlation between state-specific infection rates and quantity of imported Mexican jalapeño and Serrano peppers to U.S. states by the first-level consignee but not for imported Mexican tomatoes. We localized production regions of interest by finding that quantities of both peppers and tomatoes imported from the states of Nuevo León and Tamaulipas were correlated with infection rates. In outbreaks possibly caused by agricultural commodities, analysis of import databases may foster a better understanding of growing seasons, harvest sites, shipment itineraries, and consignee destinations, thereby adding valuable insight into findings derived from epidemiologic studies.

Role of the U.S. Food and Drug Administration in the regulatory management of human listeriosis in the United States.

From 1986 to 2006, the incidence of listeriosis in the United States dropped from approximately seven to three cases per million population, a reduction that most likely reflects the joint efforts of industry, government, consumers, and academia. Herein, we describe the U.S. Food and Drug Administration (FDA) strategy over the past three decades to combat listeriosis. Specifically, we discuss early actions taken to address outbreaks during the 1980s, policy decisions regarding the presence of Listeria monocytogenes in FDA-regulated foods, FDA compliance programs with L. monocytogenes components, enforcement actions to remove L. monocytogenes-contaminated products from the market (i.e., recalls) or to prevent entry of such products into the market (i.e., import detentions and refusals), research milestones, outreach and education efforts, and selected special projects. Evolving demographic trends in the United States may pose a challenge to further reduction of the incidence of listeriosis.

Geospatial Mapping of Early Cases in Multistate Foodborne Disease Outbreaks: A Strategy To Expedite Identification of Contaminated Imported Produce, United States, 2006 to 2013.

From 1998 to 2008, produce-related illness outbreaks accounted for roughly one-half of reported foodborne outbreaks in the United States. In 2013, Mexico accounted for approximately 50 and 30% of the monetary value of all vegetables and fruits, respectively, imported into the United States. We used historical import data to examine the correlation between the port of entry for five implicated produce vehicles from five multistate outbreaks and the geospatial and temporal distribution of illnesses in the corresponding outbreaks in the United States. For comparison, we analyzed the geospatial and temporal distribution of cases from two U.S. multistate outbreaks associated with domestically grown produce. The geospatial distribution of illnesses in the two outbreaks linked to domestic produce differed from that of the import-related produce outbreaks. The results of our pilot study suggest that geospatial distribution of early-onset cases may be used to identify ports of entry for produce likely to be responsible for causing multistate outbreaks in the United States and that targeted sampling of produce items from these ports of entry may expedite identification of an outbreak vehicle.

Consumption of dietary supplements containing Citrus aurantium (bitter orange)--2004 California Behavioral Risk Factor Surveillance Survey (BRFSS).

BACKGROUND: Following the marketing ban of ephedra-containing supplements in April 2004, many manufacturers substituted the herb Citrus aurantium for ephedra and marketed the products as "ephedra-free" supplements. Extracts of C. aurantium contain synephrine, a sympathomimetic alkaloid. OBJECTIVE: To determine the prevalence of consumption of dietary supplements containing C. aurantium in California during 2004. METHODS: We used the 2004 California Behavioral Risk Factor Surveillance Survey to determine the prevalence of consumption of dietary supplements containing C. aurantium in California during 2004. RESULTS: Two percent (n = 70) of the 4140 survey respondents reported taking a dietary supplement containing C. aurantium in the previous year. Reasons stated included energy enhancement, weight loss, and appetite suppression. Compared with nonusers, users were more likely to report being single, aged 18-34 years, and Hispanic; consuming 3 or more alcoholic drinks on days that they imbibed; and having a heavier body mass index. Among the 5 users who reported experiencing an adverse event that they attributed to the supplement, 3 indicated that the severity was mild. CONCLUSIONS: Given that supplements containing ephedra were banned in April 2004, the results from this study may serve as a baseline estimate against which future studies of the use of C. aurantium products may be compared.

Recalls of spices due to bacterial contamination monitored by the U.S. Food and Drug Administration: the predominance of Salmonellae.

From 1980 to 2000, the annual per capita consumption of spices in the United States increased by 60% (from 1.0 to 1.6 kg per person per year). Although spices are known to harbor various molds, fungi, and bacteria, relatively few reports have documented this group of foods as the cause of human illness. In recent years, however, the U.S. Food and Drug Administration (FDA) has noted an increased number of recalls of dried spices due to bacterial contamination. Accordingly, we reviewed spice recalls that took place in the United States from fiscal years 1970 to 2003. During the study period, the FDA monitored 21 recalls involving 12 spice types contaminated with bacterial pathogens; in all but one instance, the recalled spices contained Salmonella. Paprika was the spice most often involved in the recalls. A wide variety of countries were the source of the recalled spices. Using data from the Centers for Disease Control and Prevention National Salmonella Surveillance System, we were unable to discern any increases in the reported incidence of laboratory-confirmed salmonellosis in states that received spices contaminated with selected rare Salmonella serotypes. A variety of effective methods exist to disinfect spices, procedures that have attained increased importance given the frequent use of spices in ready-to-eat foods and the potential for contaminated spices to cause widespread outbreaks.

Treatment of drug-resistant Shigella infections.

Since the introduction of sulfonamides in the late 1930s, selective pressure and the widespread dissemination of mobile genetic elements conferring antimicrobial resistance have forced clinicians to seek successive agents for the treatment of multidrug-resistant shigellosis. Over the decades, the principal antibiotics used to treat Shigella infections have included tetracycline, chloramphenicol, ampicillin, trimethoprim-sulfamethoxazole, and nalidixic acid. Presently, ciprofloxacin, azithromycin, and ceftriaxone serve as the mainstays of treatment, although growing evidence has documented decreased susceptibility or full resistance to these agents in some regions. With diminishing pharmaceutical options available, there is an enhanced need for preventive measures in the form of improved sanitation and hygiene standards, strict use of currently effective agents, and a safe and effective licensed vaccine.

Evaluation of the Level of Food Safety Protection Provided by the U.S. Grade "A" Pasteurized Milk Ordinance and Its Associated Cooperative Grade "A" Milk Safety Program.

The present study was conducted to evaluate the level of food safety protection provided to consumers of Grade "A" milk and milk products in the United States by the National Conference on Interstate Milk Shipments (NCIMS) Grade "A" Milk Safety Program through its implementation and enforcement of the U.S. Grade "A" Pasteurized Milk Ordinance (PMO). The number of reported illnesses associated with Grade "A" milk and milk products in the United States was obtained from state and federal agencies and published articles. The consumption of Grade "A" milk and milk products in the United States was estimated from food consumption survey data for individuals. The level of food safety protection was measured quantitatively using the metric of annual illness attack rate. During a 15-year period (1999 through 2013), the estimated annual illness attack rate was 0.41 reported illnesses per 1 billion exposures (estimated using person-day intake data) or 0.52 reported illnesses per 1 billion lb (454 million kg) of Grade "A" milk and milk products consumed. Food safety protection provided to consumers of Grade "A" milk and milk products by the NCIMS through its implementation and enforcement of the PMO is important given the common consumption of Grade "A" milk and milk products in the United States.

The Role of Adverse Event Reporting in the FDA Response to a Multistate Outbreak of Liver Disease Associated with a Dietary Supplement.

OBJECTIVE: Liver disease is a potential complication from using dietary supplements. This study investigated an outbreak of non-viral liver disease associated with the use of OxyELITE Pro(TM), a dietary supplement used for weight loss and/or muscle building. METHODS: Illness details were ascertained from MedWatch reports submitted to the U.S. Food and Drug Administration (FDA) describing consumers who ingested OxyELITE Pro alone or in combination with other dietary supplements. FDA's Forensic Chemistry Center analyzed samples of OxyELITE Pro. RESULTS: From February 2012 to February 2014, FDA received 114 reports of adverse events of all kinds involving consumers who ingested OxyELITE Pro. The onset of illness for the first report was December 2010 and for the last report was January 2014. Thirty-three states, two foreign nations, and Puerto Rico submitted reports. Fifty-five of the reports (48%) described liver disease in the absence of viral infection, gallbladder disease, autoimmune disease, or other known causes of liver damage. A total of 33 (60%) of these patients were hospitalized, and three underwent liver transplantation. In early 2013, OxyELITE Pro products entered the market with a formulation distinct from products sold previously. The new formulation replaced 1,3-dimethylamylamine with aegeline. However, the manufacturer failed to submit to FDA a required "new dietary ingredient" notice for the use of aegeline in OxyELITE Pro products. Laboratory analysis identified no drugs, poisons, pharmaceuticals, toxic metals, usnic acid, N-Nitroso-fenfluramine, pyrrolizidine alkaloids, aristocholic acid, or phenethylamines in the products. CONCLUSIONS: Vigilant surveillance is required for adverse events linked to the use of dietary supplements.

Sulfites--a food and drug administration review of recalls and reported adverse events.

Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested > or = 10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

Acute Metallosis Following Total Knee Replacement - A Case Report.

INTRODUCTION: Metallosis involving the knee joint most often results from metal-on-metal contact late in the life of a failing implant following polyethylene wear. We report a case of acute metallosis following knee arthroplasty in a previously healthy 59-year old male. CASE REPORT: In June 2011, the patient underwent left knee arthroplasty for severe osteoarthritis with necrosis and bone edema in the medial femoral condyle and tibial plateau. Nine months later, because of persistent pain and swelling in the joint, revision arthroplasty was undertaken along with partial synovectomy. Examination revealed pristine prosthetic implants in the absence of loose fragments of bone or glue. Synovial pathology exhibited marked chronic inflammation and hyperplasia with extensive finely granular foreign material resembling metallic debris. Laboratory analysis of synovium revealed a predominance of iron, the principal component of the saw blades. CONCLUSION: We hypothesize the patient experienced acute metallosis resulting from deposition of metallic fragments from three saw blades used during arthroplasty. We believe the increased density of the patient's bone that required use of multiple blades may have resulted, in part, from heavy lifting the patient partook in during the two years preceding arthroplasty.

Recalls of foods due to microbiological contamination classified by the U.S. Food and Drug Administration, fiscal years 2003 through 2011.

Recalls of foods contaminated with pathogens help reduce the transmission of infectious diseases. Here, we summarize the number and nature of foods recalled as a result of microbiological contamination, classified by the U.S. Food and Drug Administration for the period 1 October 2002 through 30 September 2011. Microbiological contamination accounted for 1,395 (42%) of 3,360 recalls of food during this period. Nuts and edible seeds, followed by fishery-seafood products and spices, were the types of products most commonly recalled for microbiological contamination. Salmonella contamination accounted for the greatest number of food products recalled due to microbiological contamination, and was the pathogen most often linked to reported outbreaks involving recalled food products.