One person has died and more than 40 made ill, including an unknown number of patients in Louisiana, after being treated with an intravenous saline solution that was neither sterile nor meant for use in people, according to federal health officials.
The U.S. Food and Drug Administration has issued a safety alert, warning providers and pharmacies against using Wallcur’s simulated IV saline solution, Practi-0.9% sodium chloride solution. The solution was shipped to medical clinics, surgical centers and urgent care facilities in several states. “Adverse events” associated with the saline include fever, chills, tremors and headache.
“Some patients were hospitalized, and there is one death associated with the use of these products; it is not know if this death is directly related to the use of the product,” the FDA says in a safety alert.
The FDA alert does not specify where the death took place or how many incidents took place in Louisiana. FDA officials were not immediately available for comment.
FDA spokesman Christopher C. Kelly said the agency is not releasing those details for now.
"We will put out additional information when we are able to do so," Kelly said. "Most importantly, we are working to inform health care professionals to carefully check their supply and not inject these products into patients (human and animals)."
Saline solution has a number of uses, including restoring fluid to dehydrated patients.
The FDA and the Centers for Disease Control and Prevention are investigating. The agencies are collecting samples of the solution from clinics and distributors and testing them to find out if the products caused the problems.
The seven states where problems were reported are Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado.
It’s unclear whether an ongoing shortage of intravenous saline solution played a part in the problem. In its safety alert, the FDA says it has been working with manufacturers to increase the supply of the solution.
Hospital officials in Baton Rouge and New Orleans have previously said they had no problems getting saline solution.