FDA Roundup: November 8, 2022

SILVER SPRING, Md., Nov. 8, 2022 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA warned health care professionals to be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to reverse its effects. Xylazine is FDA-approved for use in animals as a sedative and pain reliever; however, FDA is aware of increasing reports of serious side effects from individuals exposed to fentanyl, heroin and other illicit drugs contaminated with xylazine.

• On November 7-8, the FDA is hosting two connected public workshops with the National Institutes of Health "Diagnostic and Monitoring Medical Devices for Opioid Use" and "Risk Prediction Devices of Opioid Use and Opioid Use Disorder – Opportunities and Challenges." The purpose of these two workshops is to promote medical device innovation through discussions with stakeholders about important factors to inform the conduct of clinical studies for diagnosing, monitoring, and managing individuals across the spectrum of opioid use disorder. CDRH hopes the valuable information gleaned from the discussions with patients, caregivers, health care providers, device innovators, researchers and other stakeholders during this workshop will help drive innovation forward in this important area. You can read the full statement here.

• On Monday, the FDA warned consumers that aspirin-containing antacid medicines to treat heartburn, sour stomach, acid indigestion or upset stomach can cause stomach or intestinal bleeding in some people. Aspirin is commonly used to reduce pain and fever, but it can increase the risk of bleeding, including in the stomach and digestive tract.

• On November 4, the Interagency Food Safety Analytics Collaboration's (IFSAC) newest annual report, "Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States," was issued. IFSAC is a collaboration between the CDC, the FDA, and the U.S. Department of Agriculture's Food Safety and Inspection Service.

• On November 4, the FDA released information regarding bebtelovimab's expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. Bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. There are several treatments that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1.

At this time, bebtelovimab remains authorized in all U.S. regions until further notice by the FDA. Prescribers should monitor CDC regional variant frequency data and refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area.

• On November 1, the FDA convened a virtual public meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to share information and perspectives from interested parties about ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations. The FDA is reviewing the committee's recommendations and will consider additional actions as needed. The FDA will share with the public any additional updates to the information and recommendations in our safety communication.

• COVID-19 testing updates:
• As of today, 435 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 77 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
  
  
• The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1153 revisions to EUA authorizations.

 Additional Resources: 

• FDA Newsroom

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

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

SOURCE U.S. Food and Drug Administration