Biomic Sciences Recalls Nasal Rinse Products
According to a recent FDA MedWatch announcement, Biomic Sciences is recalling all lots of ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray products because FDA testing found the product to contain microbial contamination.
No reports of adverse events have been reported to Biomic Sciences to date, but the concern is that in at-risk populations, or those who have recently undergone nasal or sinus surgery, use of these products could potentially result in severe or life-threatening adverse events such as bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection.Read More
Smoking During Pregnancy More Dangerous Than Thought
Smoking during pregnancy has long been associated with premature birth, but now researchers from the University of Cambridge suggest the problem is much worse than anyone thought.
Their study of 914 women found those who smoked while pregnant were 2.6 times more likely to have a premature baby than those who did not. That’s more than double the previous estimates. These women also were 4.1 times more likely to experience fetal growth restriction and had babies that were on average 10% lighter than their nonsmoking peers.
Contrary to other studies, these researchers found no evidence that smoking reduced the risk of preeclampsia.
Overall, 78.6% of the women in the study were classified as having no exposure to cigarette smoke during pregnancy, 11.7% had some exposure, and 9.7% had consistent exposure.
Interestingly, the investigators found no link between adverse outcomes and caffeine intake among the women in their study, despite the fact other studies have suggested high caffeine intake during pregnancy can lead to lower birthweights and even fetal growth restriction.
They believe their findings on smoking suggest more needs to be done to ensure women quit smoking while pregnant. “We hope this knowledge will help encourage pregnant mums and women planning pregnancy to access smoking cessation services,” said study author Professor Gordon Smith. “Pregnancy is a key time when women quit and if they can remain tobacco free after the birth there are lifelong benefits for them and their child.”
The study was published by the International Journal of Epidemiology.Read More
A study conducted among more than 7,600 current and former smokers suggests those with suspected bronchiectasis have a higher risk of all-cause mortality even if they do not have COPD.
The finding comes from researchers from Brigham and Women’s Hospital who analyzed data from the COPDGene study. Specific results showed 17.6% of the participants had suspected bronchiectasis, and over a follow-up of 11 years, these participants had a 15% higher risk for all-cause mortality.
Suspected bronchiectasis was defined as an incidental finding of bronchiectasis on CT scan plus symptoms. According to the researchers, incidental bronchiectasis is found in between 12% and 30% of adults with a history of smoking who have CT images taken.
However, the authors did not find a higher all-cause mortality rate in people without COPD who had evidence of bronchiectasis on CT scan but no clinical manifestations.
The study was published by the Annals of Internal Medicine. Read More
A new model for prioritizing people on the lung transplant waiting list could improve organ allocation, report researchers from the Cleveland Clinic who came up with the model.
The model attempts to improve on the current Composite Allocation Score (CAS) that assigns a number to candidates based on factors like how stable they are, their chances of survival after receiving a new organ, and how easily they can be matched to a donor.
“The problem with this method is that the scoring equations fail to consider how a patient’s health status changes as they spend more time on the list,” said Maryam Valapour, MD, MPP, director of Lung Transplant Outcomes at the Cleveland Clinic. “The longer a patient lives with a severe lung disease, the more their risk of developing severe complications increases. Therefore, some patients’ scores may not reflect how urgently they need a transplant.”
The new model is based on data from 12,000 American adults listed for a lung transplant between 2015 and 2020. The investigators found the risk of death prior to transplant often increased along with the amount of time spent on the list. The analysis indicated some of those who died while on the waiting list had not been given enough priority in the CAS.
The new model, dubbed the Multistate Composite Model, accounts for the type of lung disease the person has and the time they have spent on the waiting list.
“The approaches we present in our paper are capable of identifying whose trajectory is more stable on the waiting list versus those whose trajectory is worsening between six-month clinical updates,” said Jarrod Dalton, PhD, director of Lerner Research Institute’s Center for Populations and Health Research and first author of the paper. “This approach may allow us to more accurately prioritize time-sensitive lung transplant candidates and decrease waitlist mortality for patients with end-stage lung disease.”
The study was supported by the National Institutes of Health and published by the American Journal of Respiratory and Critical Care MedicineRead More
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