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FDA Gives Update on Saline Shortage in Midst of Severe Flu Season

Posted 01 February 2018 | By Michael Mezher 

FDA Gives Update on Saline Shortage in Midst of Severe Flu Season

On Thursday, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb gave an update on FDA's efforts to address the shortage of saline products in the midst of a harsh flu season.

"This year's flu season has been particularly challenging, with a notable number of cases leading to hospitalization," Gottlieb said, adding that the predominant strain of Influenza A virus has led to more severe complications than in recent years.

On top of a worse-than-normal flu season, the supply of intravenous (IV) saline bags has been constrained in the US since Hurricane Maria disrupted their production in Puerto Rico.

In response, FDA announced in October it would temporarily allow Baxter Healthcare, a leading producer of saline solutions to import sodium chloride and glucose IV infusion products from its facilities in Ireland and Australia.

Gottlieb added that FDA is working to allow Baxter and B. Braun to import saline products from additional facilities, including a Baxter facility in Brazil.

And while FDA says the supply of saline products is improving, this year's lengthy flu season has led to sustained demand and prompted healthcare providers to look to workarounds such as compounding their own saline solution, which in turn has led to a shortage of empty IV containers used to hold the compounded solutions.

Gottlieb said FDA is currently working with manufacturers and healthcare providers to determine what types of empty IV containers are in the highest demand, and that several manufacturers, including Douglas Medical Products, Summit Medical Products and Valmed SRL have said they may be able to increase production of empty IV containers.

Gottlieb also noted that while FDA has heard of some isolated shortages of antiviral drugs and flu diagnostics, none of those products nor the influenza vaccine is affected by a nationwide shortage.


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