FDA Commissioner vows initiatives to tackle saline shortages
As U.S is facing the wrath of flu that has become widespread in U.S, FDA continues to oversee this situation closely. FDA Commissioner, Scott Gottlieb vows to take steps to curb saline shortages and paucity ensuring that people with the flu have access to critical medical products, including antivirals, saline and other supportive care drugs and devices.
Scott Gotttlieb states “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.”
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.
He expects saline shortages to wane over the next month, having adequate supplies, especially during this severe flu season, is a critical matter of public health. Most recently, the FDA was able to extend the expiration dates of certain products, including some 500 ml size saline bags, after carefully examining the data submitted by the company to ensure that it meets the FDA’s quality and safety standards. They continue to encourage companies to submit data to extend expiration dates for drugs in shortage.
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