FDA’s investigation into patients being injected with simulated IV fluids continues
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are continuing to investigate multiple instances of Wallcur simulated saline solution being administered to patients. To date, we are aware of more than 40 patients who have received infusions of the simulated saline products. Some of the patients experienced adverse events associated with these products including fever, chills, tremors and headache.
FDA and CDC have taken a number of steps to remove the simulated saline products from medical settings, to raise awareness among health care providers, and to provide information to state and local health officials in order to prevent exposure to additional patients.
FDA is reiterating its previous recommendations that ask health care professionals and consumers to do the following:
- Be vigilant and report any suspected adverse events following use of these products to FDA’s MedWatch program online or at 1-800-332-1088
- Visually inspect all current IV saline solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-0.9% saline,” or “For clinical training purposes only”
- Consider reviewing clinic procedures and make sure there are procedures in place to visually inspect all future shipments of IV products to ensure they are appropriate for clinical use
View the full FDA update here: http://www.fda.gov/Drugs/