What is E. coli?

E. coli are mostly harmless bacteria that live in the intestines of people and animals and contribute to intestinal health. However, eating or drinking food or water contaminated with certain types of E. coli can cause mild to severe gastrointestinal illness. Some types of pathogenic (illness-causing) E. coli, such as Shiga toxin-producing E. coli (STEC), can be life-threatening.

People infected with pathogenic E. coli can start to notice symptoms anywhere from a few days after consuming contaminated food or as much as nine days later. Generally, the symptoms include severe stomach cramps, diarrhea, fever, nausea, and/or vomiting.

The severity or presence of certain symptoms may depend on the type of pathogenic E. coli causing the infection. Some infections can cause severe bloody diarrhea and lead to life-threatening conditions, such as a type of kidney failure called hemolytic uremic syndrome (HUS), or the development of high blood pressure, chronic kidney disease, and neurologic problems. Other infections may have no symptoms or may resolve without medical treatment within five to seven days.

Due to the range in severity of illness, people should consult their health care provider if they suspect that they have developed symptoms that resemble an E. coli infection, including HUS, but even healthy older children and young adults can become seriously ill.

People of any age can become infected with pathogenic E. coli. Children under the age of 5 years, adults older than 65, and people with weakened immune systems are more likely to develop severe illness as a result of an E. coliinfection. However, even healthy older children and young adults can become seriously

Outbreak Investigation of lllnesses caused by E. coli O157:H7 November 2019

FDA working to determine the source of contamination found in Ready Pac Bistro Chicken Caesar Salad, FSIS Announces Recall

On Nov. 21, 2019, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced a recall by Missa Bay, LLC, a Swedesboro, N.J. establishment. The salad products subject to the recall can be found in a spreadsheeton the FSIS website and bear the USDA mark of inspection.

Do not eat the recalled products.

The salad product items were produced from Oct. 14, 2019 through Oct. 16, 2019, and the recommended “use by” date for all of the product was Nov. 1, 2019, or earlier. There is concern that some products may be in consumers’ refrigerators, or that portions may have been frozen, even though they are past their use by dates. These products should be thrown away or returned to the place of purchase.

Background

FDA, CDC, FSIS and state health authorities are investigating an outbreak of illnesses caused by E. coli O157:H7 in the U.S.

Products in the recall noted above were produced with the same lot of lettuce that was used to produce the packaged salad that the Maryland Department of Health found to contain E. coli 0157:H7.

That product was Ready Pac Bistro® Chicken Caesar Salad, lot #255406963, UPC 0 77745 27249 8, “Best By” date Oct. 31, 2019, and it is included in this recall.

FDA is tracing back the supply of the romaine lettuce in the Caesar salad. FDA has identified possible farms in Salinas, California. FDA is deploying investigators to determine the source and extent of the contamination. More information will be forthcoming as the investigation proceeds.

Although the ill people interviewed in Maryland reported eating Ready Pac Bistro® Chicken Caesar Salad, at this time, ill people in other states have not reported eating this particular salad. Therefore, exposure to this product alone does not fully explain other cases in the outbreak.

Case Counts

Total Illnesses: 17
Hospitalizations: 7
Deaths: 0
Last illness onset: November 8, 2019
States with Cases: AZ (1), CA (2), CO (1), ID (3), MD (2), MT (1), WA

FDA APPROVES NEW TREATMENT FOR ADULTS WITH PARTIAL ONSET-SEIZURES

The U.S. Food and Drug Administration today approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults“XCOPRI is a new option to treat adults with partial-onset seizures, which is an often difficult-to-control condition that can have a significant impact on patient quality of life,” said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Patients can have different responses to the various seizure medicines that are available. This approval provides an additional needed treatment option for people with this condition.”  

A seizure is a usually short episode of abnormal electrical activity in the brain. Seizures can cause uncontrolled movements,  abnormal thinking or behavior, and abnormal sensations. Movements can be violent, and changes in consciousness can occur. Seizures occur when clusters of nerve cells (neurons) in the brain undergo uncontrolled activation. A partial-onset seizure begins in a limited area of the brain

The safety and efficacy of XCOPRI to treat partial-onset seizures was established in two randomized, double-blind, placebo-controlled studies that enrolled 655 adults. In these studies, patients had partial-onset seizures with or without secondary generalization for an average of approximately 24 years and median seizure frequency of 8.5 seizures per 28 days during an 8-week baseline period.

During the trials, doses of 100, 200, and 400 milligrams (mg) daily of XCOPRI reduced the percent of seizures per 28 days compared with the placebo group. The recommended maintenance dose of XCOPRI, following a titration (medication adjustment) period, is 200 mg daily; however, some patients may need an additional titration to 400 mg daily, the maximum recommended dose, based on their clinical response and tolerability

FDA, CDC, and state health authorities are investigating an outbreak of illnesses caused by E. coli O157: H7 in the U.S.

Regulatory focus news letter

According to the CDC, as of November 18, 2019, 17 people infected with the outbreak strain of E. coli O157:H7 have been reported from eight states. The case patients report that illnesses started on dates ranging from September 24, 2019 to November 8, 2019.

Two cases reported from Maryland have been linked to this outbreak by Whole Genome Sequencing (WGS), through analysis of clinical samples taken from those patients. The Maryland Department of Health identified E. coli O157 in an unopened package of Ready Pac Bistro® Chicken Caesar Salad collected from a ill person’s home in Maryland which was purchased from a Sam’s Club in that state. Preliminary information indicates that romaine lettuce used in the product that tested positive was harvested in mid-October and is no longer within current expiration dates. To date, the food sample has not yet been definitively linked to the Maryland cases or other E. coli O157 illnesses in the multi-state outbreak. WGS analysis is currently underway for this sample to determine if it is closely related genetically to the E. coli found in people in this outbreak.

As analysis is underway, FDA is tracing back the supply of the romaine lettuce in the Caesar salad. FDA has identified possible farms in Salinas, California. FDA is deploying investigators to the farms in question to determine the source and extent of the contamination. More information will be forthcoming as the investigation proceeds.

Although the ill people interviewed in Maryland reported eating Ready Pac Bistro® Chicken Caesar Salad, at this time, ill people in other states have not reported eating this particular salad. Therefore, exposure to this product alone does not fully explain other cases in the outbreak.

For Quality & Regulatory Compliance

Thanks for joining me!

Good company in a journey makes the way seem shorter. — Izaak Walton