No abstract

Background Muscletech Hydroxycut® (Iovate Health Sciences Research, Oakville, Ontario) was a popular weight loss supplement that was recalled by the manufacturer in May 2009 based on reports of hepatotoxicity associated with this supplement. Objective To characterize the clinical presentation of Hydroxycut®-associated liver injury and to adjudicate these cases for causal association with Hydroxycut®. Design Case series. Setting Academic tertiary care hospitals and FDA databases. Measurements Assessment of 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 3 of 8 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 8 cases as definite, 5 highly likely, 2 probable and 2 were considered as 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.

Although not well quantified, a portion of food-borne illnesses results from voluntary behaviors that are entirely avoidable, such as eating raw foods of animal origin or engaging in unsafe food preparation practices. A telephone survey of 1,620 respondents was conducted to assess the prevalence of selected self-reported food consumption and preparation behaviors associated with increased risks of food-borne illness and the demographic characteristics related to such behaviors. The percentages of survey respondents who reported consuming raw foods of animal origin were 53%, raw eggs; 23%, undercooked hamburgers; 17%, raw clams or oysters; and 8%, raw sushi or ceviche. A fourth of the respondents said that after cutting raw meat or chicken, they use the cutting board again without cleaning it. Safer food consumption and preparation behaviors were consistently reported by persons who were female, were at least 40 years old, and had a high-school education or less. These findings suggest that risky food consumption and preparation behaviors are common in the United States and that educational campaigns aimed at changing these behaviors may need to be targeted to specific groups of persons.

Clinicians should ask about marine exposures in patients with underlying medical conditions, especially liver disease, who present with unexplained febrile illness, and should start appropriate therapy promptly.

BACKGROUND. In August 1988 we investigated a multistate outbreak of hepatitis A caused by Panama City, Florida, raw oysters. METHODS. Cases of hepatitis A (HA) with onset in July-August 1988 were identified among persons who ate seafoods harvested in the coastal waters of Panama City, Florida. We conducted a case-control study, using eating companions of case-patients, and calculated attack rate (AR) per 1000 dozen raw oysters served. Enzyme immunoassay (EIA) and a polymerase chain reaction (PCR) technique were performed on samples of raw shellfish obtained from Panama City coastal waters. RESULTS. Sixty-one case-patients were identified in five states: Alabama (23), Georgia (18), Florida (18), Tennessee (1), and Hawaii (1). We found an increased risk of HA for raw oyster eaters (odds ratio = 24.0; 95% confidence interval = 5.4-215.0; P less than .001). The AR of HA in seafood establishments was 1.9/1000 dozen raw oysters served. The EIA and PCR revealed HA virus antigen and nucleic acid in oysters from both unapproved and approved oyster beds, in confiscated illegally harvested oysters, and in scallops from an approved area. CONCLUSIONS. The monitoring of coastal waters and the enforcement of shellfish harvesting regulations were not adequate to protect raw oyster consumers. More emphasis should be placed on increasing public awareness of health hazards associated with eating raw shellfish.

OBJECTIVES: This study describes the epidemiology of raw milk-associated outbreaks reported to the Centers for Disease Control and Prevention from 1973 through 1992. METHODS: Surveillance data for each reported raw milk-associated outbreak were reviewed. A national survey was conducted to determine the legal status of intrastate raw milk sales for the period 1973 through 1995. RESULTS: Forty-six raw milk-associated outbreaks were reported during the study period; 40 outbreaks (87%) occurred in states where the intrastate sale of raw milk was legal. CONCLUSIONS: Consumption of raw milk remains a preventable cause of foodborne disease outbreaks.

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™, 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.

In the U.S., food product recalls serve as an important intervention in stemming the consumption of food products contaminated with infectious disease agents. We summarize the number and nature of foods and cosmetics recalled as a result of microbial contamination reported to the U.S. Food and Drug Administration (FDA) for the period 1 October 1993 through 30 September 1998. During this period, microbial contamination of food and cosmetic products was the leading cause for recalls, accounting for a total of 1,370 recalls (36% of all products recalled). Listeria monocytogenes accounted for the greatest number of food products recalled because of microbial contamination, whereas Pseudomonas aeruginosa was the most common microbe associated with recalls of cosmetic products. Dairy products, followed by seafood and pastry items, were the types of products most often associated with recalls due to microbial contamination. The FDA was the entity most often responsible for detecting microbial contamination of foods and cosmetics (33% of all such recalls), followed by state regulatory agencies (24%), and manufacturers/retailers (21%). Nineteen percent of recalls were associated with at least one reported case of illness. Salmonella was the pathogen most often implicated in reports of illness associated with these recalled products.