The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur simulated saline solution being administered to patients. To date, the agencies 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.
The FDA and the CDC have taken a number of steps to remove the simulated saline products from medical settings, to raise awareness among healthcare providers, and to provide information to state and local health officials in order to prevent exposure to additional patients.
The FDA has been working closely with Wallcur to make several changes to their labeling and marketing practices to prevent this from occurring again. Wallcur has voluntarily:
- Recalled all Practi-0.9% sodium chloride IV bags supplied in 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL sizes
- Notified all customers and distributors who received recalled products
- Added stickers to existing packaging and labeling of Practi-0.9% sodium chloride IV bags to explicitly warn users that the simulated products are not intended for human or animal use and are for training purposes only
- Continued discussions with FDA concerning labeling recommendations for all simulation products
The 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 at: http://www.fda.gov/Drugs/DrugSafety/ucm428431.htm.
Source: FDA and CDC