FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season - Drug Information Update

	The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA

As flu activity remains widespread across the U.S., the FDA continues to monitor this situation closely and in coordination with our colleagues at the U.S. Centers for Disease Control and Prevention. We’re continuing to take steps to help ensure that people with the flu have access to critical medical products, including antivirals, saline and other supportive care drugs and devices.

This year’s flu season has been particularly challenging, with a notable number of cases leading to hospitalization. The season started earlier than usual and seemed to spread across many states quickly. H3N2, the predominant strain of the influenza A virus this season, has led to health complications that are more severe than those seen during an H1N1-predominant season. We recognize that managing the thousands of flu-related hospitalizations has increased the demand for certain saline products – which are commonly used to both hydrate and deliver medications via intravenous routes. As we’ve shared over the past several months, across the country, there remains a shortage of IV saline bags, which have long faced supply issues. These supply issues were worsened by the impact of Hurricane Maria on the medical products manufacturing sector in Puerto Rico, which impacted small volume IV bags. Although the saline shortage is improving, this year’s worse-than-normal flu season and workarounds deployed by health care providers in the wake of this shortage have increased demand for saline and other products.

The products include large volume saline bags typically used to hydrate patients; small volume IV saline bags (generally in 50 and 100 ml sizes) that are often used to deliver other medicines; as well as empty IV containers of varying sizes that are being used by many health care providers to compound their own IV saline solutions by filling these empty containers. As such, we’re actively working to improve the large and small IV bag shortage and tracking potential shortages of critical medical products, such as the empty IV containers.

We are also hearing from some health care providers that there are spot shortages of some antivirals used to treat the flu and flu tests; however, at this time, there is no nationwide shortage of these products. The FDA is carefully monitoring the situation and we will provide updates as needed. Along with antivirals and device products we are also monitoring influenza vaccine supplies. While there have been some reported spot shortages, flu vaccines are still available. I strongly encourage anyone who hasn’t had a flu shot to get one and anyone experiencing flu-like symptoms to promptly consult with their health care provider about appropriate treatment options.

For more information, please visit: Saline Shortage