WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued a series of important updates addressing healthcare challenges, regulatory actions, and emerging safety concerns, with implications for medical providers, consumers, and industry stakeholders.
The FDA recently notified healthcare providers about a shortage of hemodialysis bloodlines due to supplier disruptions. This critical device, used in both acute and chronic hemodialysis, is essential for patients with kidney failure. The shortage, which is expected to persist through early fall 2025, has prompted the FDA to recommend clinicians consider conservation strategies and exercise clinical judgment in managing supplies. The shortage has also been added to the agency’s official medical device shortage list.
Separately, the FDA granted conditional approval for Felycin-CA1, a delayed-release sirolimus tablet, for veterinary use in treating ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM). This marks the first FDA-approved product addressing HCM, the most common heart disease in cats. Available by prescription, Felycin-CA1 offers an innovative option for managing this serious condition in feline patients.
On the consumer safety front, the FDA issued a warning against the inhalation or recreational use of nitrous oxide. The alert outlines risks including severe neurological damage and, in extreme cases, death. While nitrous oxide is commonly used in medical and food applications, misuse of the substance can result in lasting harm, according to the FDA.
Lastly, the agency announced the entry of a consent decree of permanent injunction against Totally Cool, Inc., a Maryland-based frozen dessert manufacturer, and its CEO, Michael J. Uhlfelder. Following an inspection that uncovered unsanitary conditions and contamination with Listeria monocytogenes, the FDA suspended Totally Cool’s food facility registration in July 2024. The decree prohibits the company from resuming operations until it complies with the FDA’s safety and sanitation requirements.
These updates address public health concerns, safeguard food safety, advance veterinary medicine, and respond to supply chain challenges. Each of these actions seeks to protect consumers and support healthcare providers in the face of evolving challenges.
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