Plegisol Discontinuation Prompts Urgent Shift for French Cardiac Surgery Centers
PARIS, FRANCE – French hospitals utilizing plegisol, a cardioplegic solution used during cardiac surgery with extracorporeal circulation (CEC), have been alerted to its impending discontinuation. Pharmaceutical manufacturer Pfizer has announced it will cease marketing Plegisol in France as of October 31, 2025, due to regulatory changes surrounding the use of DEHP (2-ethylhexyl phthalate).
The decision stems from Annex XIV of the European REACH Regulation (Regulation (EC) n° 1907/2006), which strictly limits the use of DEHP in packaging for pharmaceuticals marketed within the European Union after December 14, 2024. DEHP is a component of the packaging currently used for Plegisol. Currently, 19 hospitals in France rely on Plegisol for their CEC procedures.
Authorities emphasize that viable alternatives to Plegisol already exist and are currently employed by many hospitals, including hospital-prepared formulations.The French Society of Thoracic and Cardiovascular Surgery (SFCTCV), the French Society of Anesthesia and Resuscitation (SFAR), and the French Company for Circulatory Assistance and Extracorporeal Circulation (SFACCEC) are actively working to support CEC centers in transitioning to choice cardioplegic solutions.
“establishments must consider now, in connection with their cardio-perfusionist teams, to transition from Plantisol to one or more alternative therapeutics, in order to ensure the continuity of interventions,” the declaration states.
The SFCTCV and SFAR are prepared to offer guidance on available cardioplegia options and assist teams in modifying their protocols. Hospitals can contact the organizations directly for support:
SFCTCV: direction@sfctcv.org
SFAR: Bureau@sfar.org
While the product will be discontinued, hospitals can continue to utilize existing Plegisol stocks until they expire on January 31, 2026, utilizing an over-the-counter process to maximize remaining supplies. This proactive approach aims to minimize disruption to critical cardiac surgery procedures across France.
