On March 13, the FDA was alerted to five cases of acute non-viral hepatitis (resulting in acute liver failure) in infants and children that occurred in November 2020 with an unknown cause reported to the Southern Nevada Health District. All five patients had been hospitalized but have since recovered. All patients were reported to have consumed “Real Water” brand alkaline water. These patients came from four different households. Five additional people, two adults, and three children, from two of the four households were reported to have experienced other symptoms as well. Less severe symptoms included fever, vomiting, nausea, loss of appetite, and fatigue.
The consumption of “Real Water” brand alkaline water is the only common link identified among all of these cases to date. This brand of alkaline water is owned by Real Water Inc., headquartered in Mesa, Arizona.
Although the investigation is ongoing, epidemiologic information currently indicates that this alkaline water product may be the cause of the illnesses.
FDA is in the beginning stages of this investigation, and there may be additional products connected to this outbreak. FDA has initiated an investigation at the firm.
As this outbreak investigation continues, the FDA will provide additional updates to this advisory as more information becomes available.
Recommendations
Consumers, restaurants, and retailers should not drink, cook with, sell, or serve “Real Water” alkaline water, until more information is known about the cause of the illnesses.
Symptoms of all types of hepatitis, including non-viral hepatitis, are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice. Those experiencing these symptoms should contact their doctor.
Case Counts
Total Illnesses: 5
Hospitalizations: 5
Deaths: 0
Last Illness Onset Date: 11/29/2020
States with Cases: NV (5)
Who to Contact
Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.
To report a complaint or adverse event (illness or serious allergic reaction), you can
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
