Bulletin Today
APhA staff
FDA suggests updated recommendations for pulse oximeters to address different skin tones
On January 6, 2025, FDA published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters. FDA encouraged device makers to improve on today’s pulse oximeters, which have been shown to potentially be less accurate in estimating blood oxygen levels in patients with darker skin tones. Pulse oximeters are important devices for patient care and are routinely used to estimate blood oxygen levels, but they have limitations and a risk of inaccuracy under certain conditions.
To address concerns of disparate performance of pulse oximeters, FDA proposed new draft recommendations advising manufacturers on the ways they can contribute to efforts in developing more accurate and more effective oximeter models that work across the range of skin pigmentations.
Some key elements of the FDA’s draft recommendations include gathering clinical data; increasing the number of clinical study participants; using both subjective (Monk Skin Tone Scale) and objective (calculation of individual typology angle) methods for more standardized evaluation of study participants’ skin tone and accurate assessment of device performance across skin pigmentations; and if performance accuracy has been demonstrated in a new premarket submission, including a prominent labeling statement to help users clearly identify that the pulse oximeter has demonstrated that it performs comparably across groups of individuals with diverse skin pigmentation and is intended for medical purposes. This draft guidance does not apply to OTC pulse oximeters sold as wellness products. ■
Study shows impact of oral nirmatrelvir/ritonavir on patients with Long COVID
Long COVID, defined as the continuation of symptoms 12 weeks or longer after an acute bout of SARS-CoV-2, has affected at least 76 million people worldwide.
A case series published in Communications Medicine on January 6, 2025, found that extended courses of nirmatrelvir/ritonavir (Paxlovid) may have meaningful benefits for some people with Long COVID.
Researchers documented a study of 13 individuals with Long COVID who initiated extended courses (>5 days; range, 7.5–30 days) of oral nirmatrelvir/ritonavir outside of and within the context of an acute SARS-CoV-2 infection.
Results revealed that among those who took an extended course of nirmatrelvir/ritonavir outside of the context of an acute infection, some experienced a meaningful reduction in symptoms, although not all benefits persist. Others experienced no effect on symptoms. The findings suggested that extended-course Paxlovid may benefit some but not all patients with Long COVID. The authors call for further study into who can benefit from the approach and what the optimal duration of dose is. ■
H5N1 avian influenza in the United States
The first human death in the United States linked to H5N1 avian influenza occurred in Louisiana, according to a CDC statement released January 6, 2025. As of that date, there have been 66 confirmed human cases of H5N1 bird flu in the United States since 2024 and 67 since 2022. CDC maintains that the risk to the general public remains low, based on the fact that the deceased had direct exposure to an infected animal.
CDC also noted that there is no evidence of transmission from one person to another and they have not observed any virologic mutations in infected wild birds, poultry, or cattle that threaten human health.
CDC continues to support critical epidemiologic investigations with state and local partners to assess the public health impact of each H5 case; work closely with state and local partners to conduct active surveillance for H5 cases; monitor for changes that may suggest H5 viruses might spread more easily and for any viral changes that could make these viruses less responsive to flu antiviral medications or the available candidate vaccine viruses.
NIH is also developing a strategy to keep the outbreak in check. While the overall threat to the U.S. population from H5N1 avian influenza A virus is believed to be low, NIH experts pointed to the need for timely and effective collaborations among researchers, health care interests, and occupational workers.
In an editorial published in NEJM on December 31, 2024, the authors emphasized the importance of effective
surveillance to stay on top of viral mutations that could influence the risk of person-to-person transmission. Additionally, the authors encouraged scientists to keep developing and testing H5N1 vaccines and therapies.
They encouraged members of the public to take steps to limit their exposure and risk of infection through educational awareness and personal protective equipment. ■
Link between alcohol and cancer risk outlined by U.S. surgeon general
Alcohol consumption is the third leading preventable cause of cancer in the United States, following tobacco and obesity.
The U.S. surgeon general issued an advisory on January 3, 2025, highlighting the increased risk of cancer related to alcohol consumption. Research has demonstrated a direct link between alcohol consumption and cancer risk for at least seven types of cancer, including cancers of the breast, colorectum, esophagus, liver, mouth, throat, and larynx, regardless of the type of alcohol consumed.
“Alcohol is a well-established, preventable cause of cancer responsible for about 100,000 cases of cancer and 20,000 cancer deaths annually in the United States—greater than the 13,500 alcohol-associated traffic crash fatalities per year in the U.S.—yet the majority of Americans are unaware of this risk,” said U.S. Surgeon General Vivek Murthy, MD.
The advisory lays out steps to increase awareness of alcohol’s cancer risk and minimize harm including asking for a health warning label on beverages containing alcohol to include cancer risk. In addition, the advisory suggests a reassessment of the guideline limits for alcohol consumption to account for cancer risk and urging public health professionals and community groups to highlight alcohol consumption as a leading modifiable cancer risk factor and increase related educational efforts. ■