Clinical Alert

Re: Importation of Baxter PD solutions from Castlebar, Ireland

Dear ASPN community,

Due to current critical shortage of Dianeal peritoneal dialysis solutions for new and existing patients in the US market, Baxter Healthcare Corporation (Baxter) is coordinating with the Food and Drug Administration (FDA) to increase the availability of the drug. Baxter has initiated temporary importation of Dianeal peritoneal dialysis solutions manufactured at Baxter’s Castlebar, Ireland facility and marketed within the European Union (EU). The FDA has not approved this product in the United States.

Below are links to 2 letters Baxter has prepared with more information and a link to the FDA Drug shortages website:(http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Peritoneal+Dialysis+Solutions&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery)

Baxter Letter to Consumer
Baxter Letter to Healthcare Professional

Some key points:

 

Contact info for Baxter:
If you have any questions about the use of DIANEAL PD4 with 1,36%, 2,27%, or 3,86% Glucose Solution for Peritoneal Dialysis products, please contact Baxter’s Medical Information Service at 1-888-736-2543, Option #2.
To report product quality issues, please contact Baxter Product Surveillance at 1-800-437-5176.
To report adverse events associated with Dianeal peritoneal dialysis solutions, please call Baxter at 1-866-888-2472 or fax: 1-800-759-1801.