SILVER SPRING, Md., Dec. 27, 2024 — The U.S. Food and Drug Administration (FDA) offers a summary of recent agency news:

• The FDA recommended label changes for transmucosal buprenorphine products used to treat opioid use disorder. These changes aim to encourage supplemental new drug applications to clarify that neither 16 mg/day nor 24 mg/day should be considered maximum dosages.
• The FDA established requirements for nonprescription drugs with an additional condition for nonprescription use (ACNU). This action, according to FDA CDER Director Patrizia Cavazzoni, M.D., broadens consumer access to nonprescription drugs, including some previously available only by prescription for chronic conditions. See the [link to document] for details.
• The FDA released findings from a literature review of studies on tampon contaminants. While limitations existed, the review found no safety concerns linked to tampon use and contaminant exposure. The FDA continues to recommend FDA-cleared tampons and is conducting a laboratory study on metals in tampon materials; results will be shared after peer review.
• The FDA approved Alhemo (concizumab-mtci) for preventing bleeding episodes in hemophilia A and B patients (12 years and older) with factor VIII or IX inhibitors. Dosage information is in the [link to document]. Common side effects (≥5% of patients) included injection site reactions and hives. Patients with a history of serious hypersensitivity to Alhemo or its components should not use it.
• The FDA’s Office of Inspections and Investigations (OII) highlighted the work of its field investigators in ensuring food safety. Deputy Associate Commissioner for Food Products Michael Dutcher, DVM, praised their dedication, particularly in responding to recent outbreaks. [Link to document] features Senior Investigator Megan Rand and [link to document] profiles investigator Alan Escalona.
• The FDA approved the alfapump System, an implanted pump for removing excess peritoneal fluid in adult patients with liver cirrhosis-related fluid buildup. This offers an alternative to repeated paracentesis procedures. The system is for single-patient use.

Additional Resources: 

# # #  

Media Contact: , 301-796-4540
Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, biological products, and medical devices. It also oversees food safety, cosmetics, dietary supplements, radiation-emitting products, and tobacco regulation.

SOURCE U.S. Food and Drug Administration