The US Food and Drug Administration (FDA) Commissioner Martin Makary has announced that the IV fluid shortage for sodium chloride 0.9% injection products is now over after nearly a year of disruption.
The overall supply chain for IV fluids was severely impacted after damage to Baxter’s North Carolina-based facility during Hurricane Helene in September 2024.
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Baxter produces around 60% of the US supply of IV fluids. By November 2024, around 86% of healthcare providers were reporting shortages.
According to Makary, resolving the shortage came down to collaboration between the FDA, the Administration for Strategic Preparedness and Response, and other industry partners who worked to expand manufacturing capacity and restore stability to the supply chain.
Makary said: “In addition, the FDA used its available regulatory tools to help increase supplies available to hospitals to help meet patient needs.”
According to the FDA chief, this included “scientific and regulatory assessments to help facilitate the temporary importation of intravenous solutions and expedited reviews to increase manufacturing capacities and extend product expiry”.
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By GlobalDataSodium chloride 0.9% injection products will now be removed from the FDA list of Current Shortages in the Drug Shortage Database on the agency’s website. However, some IV fluid shortages remain.
Makary continued: “For other IV fluids still in shortage, the FDA is working closely with manufacturers and will continue to monitor the supply to help ensure patients have access to the medicines they need.”
To address the Hurricane Helene fallout, Baxter teamed up with Vizient last month, which saw the healthcare services company add IV fluid to its Vizient Reserve Program to improve supply assurance and mitigate the shortage.
Baxter recently trimmed its profit outlook for 2025 in its Q2 2025 financials to between 6% and 7%, down from 7% to 8%, citing operational impact to its North Carolina facility as a key factor.
In an earnings call with investors, Baxter’s chief operating officer Heather Knight said: “While we have started to see a slight improvement with hospitals reducing fluid conservation efforts, our current outlook builds in potential downside risk that conservation efforts don’t materially improve in the second half of the year.”
