FDA Permits Importation of PD Solution

Last month Baxter announced they were experiencing a shortage of their peritoneal dialysis (PD) solutions.  While current patients were able to receive their shipments on time, many experienced disruptions in their normal delivery.  Many new patients were unable to start PD.  The National Kidney Foundation submitted comments to the Food and Drug Administration (FDA), urging the agency to quickly review and determine if Baxter could safely import solutions from its overseas facilities.  While NKF did not act alone in advocating for an expedited solution, we are pleased that efforts were heard and that yesterday evening the FDA announced that it will allow importation of some Dianeal solutions from Baxter’s facility in Ireland.  This is expected to help alleviate the shortage until Baxter is able to ramp up production in the U.S.

While the Dianeal solution manufactured in Ireland is the same solution made in the U.S., there are some differences in the packaging including the connectors and the quantity of solution in each bag.  You can read more about what to look for in Baxter’s letter to patients and learn more about this issue on the FDA’s website.

About nkf _advocacy

The National Kidney Foundation's advocacy movement is for all people affected by CKD, transplant candidates and recipients, living and potential donors, donor families and caregivers. We empower, educate and encourage you to get involved on issues relating to CKD, donation and transplantation.
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