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News roundup

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Aspirin may be just as good as blood thinner injections for patients hospitalized with fractures

Findings from a new clinical trial found that OTC aspirin can be just as effective as injectable low-molecular-weight heparin in preventing life-threatening blood clots for patients hospitalized with fractures.

The findings, published January 13, 2023, in NEJM, could even lead surgeons to change their practice and administer aspirin to these patients.

“Many patients with fractures will likely strongly prefer to take a daily aspirin over receiving injections after we found that both give them similar outcomes for prevention of the most serious outcomes from blood clots,” said the study’s lead investigator Robert V. O’Toole, MD, chief of orthopaedics at the R Adams Cowley Shock Trauma Center at the University of Maryland Medical Center (UMMC), in a news release. “We expect our findings from this large-scale trial to have an important impact on clinical practice that may even alter the standard of care.”

The study enrolled 12,211 patients with leg or arm fractures at 21 trauma centers in the United States and Canada. Patients had experienced a fracture of an extremity that required surgery or a pelvic fracture regardless of the treatment. Half were randomly assigned to receive 30 mg of injectable low molecular-weight heparin twice daily. The other half received 81 mg of aspirin twice daily. Patients were followed for 90 days to measure health outcomes from the two treatments.

The main finding of the study was that aspirin was noninferior, or no worse than low molecular-weight heparin in preventing death from any cause—47 patients in the aspirin group died, compared with 45 patients in the heparin group. The researchers also found no differences between the two groups in pulmonary embolisms. The incidence of bleeding complications, infection, wound problems, and other adverse events from the treatments was also similar in both groups.

Of all the outcomes studied, the only potential difference noted was in deep vein thrombosis. This condition was relatively uncommon in both groups as it occurred in 2.51% of patients in the aspirin group, and in 1.71% of patients in the heparin group.

“This relatively small difference was driven by clots lower in the leg, which are thought to be of less clinical significance and often do not require treatment,” said study author Deborah Stein, MD, MPH, director of Adult Critical Care Services at UMMC, in the news release.

An estimated 1 million American are hospitalized each year with extremity fractures. According to Mark Gladwin, MD, from the University of Maryland School of Medicine, findings from this new study could help prevent potentially fatal blood clots in these patients using a medication that is cheaper and much easier to administer.

“Given these important results, we can expect the guidelines for the prevention of blood clots to be revised to include the option of aspirin for patients with traumatic bone fractures,” he said in the news release. ■

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CDC reports new drop in child vaccination rates

CDC said that disruptions in health care access during the COVID-19 pandemic contributed to declining rates of routine immunizations among young children. In a new report, the agency found that uptake of state-mandated vaccines dropped in 2021–2022 for kindergarteners.

People may still be trying to get back on schedule, and vaccine hesitancy is likely playing a role as well—even as COVID-19 lockdowns have ceased, CDC noted.

The CDC study examined data from federally funded immunization programs that work with education departments and schools nationwide to estimate vaccination rates among kindergarteners. Overall, vaccination rates were 93% in the 2021–2022 school year, down from 94% in the previous school year and 95% in the year before that.

The researchers noted that coverage for the measles, mumps, and rubella vaccine was 93.5%, below the approximately 95% rate needed for a community to avoid being prone to a measles outbreak. A recent measles outbreak in Ohio infected more than 80 children, all of whom were unvaccinated or only partially vaccinated.

CDC found in a separate study that national vaccine coverage by age 2 years continued to be strong and rose for some vaccines; however, routine vaccination dropped by several percentage points for children living below the federal poverty line or in rural areas who were born in 2018 and 2019.

Also, according to the study, the percentage of uninsured children who were not vaccinated by age 2 years was 8 times higher than that of children who were covered by private insurance. ■


image of CBD products

FDA calls for authority to regulate CBD products

Citing safety risks, FDA said that products containing cannabidiol (CBD) call for greater supervision than the agency can now offer, and FDA will request new regulating authorities from Congress.

FDA also said products derived from legal cannabis should not be regulated as they currently are (i.e., as dietary supplements or food additives) in light of the products’ risk to humans—particularly to children and pregnant people—and to animal health.

FDA’s expanded authority could include mandating clear labels, prohibiting contaminants, restricting doses, and establishing a minimum purchase age, according to the agency.

“Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplement or food additives,” said FDA Principal Deputy Commissioner Janet Woodcock in a press statement.

She also said studies suggest that long-term use of CBD products could have safety issues, such as drug interactions, potential damage to an individual’s liver, and possible harm to the male reproductive system.

When Congress legalized hemp and related products in 2018, it left their regulation to FDA. As a result, makers of CBD products have operated in the absence of specific federal rules over their marketing or manufacturing. Some states have established their own sets of rules. A report from FDA in 2021 estimated that the $4.6 billion market would quadruple by 2026. ■


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New SAMHSA data reveals mental illness and substance use levels

New data from the Substance Abuse and Mental Health Services Administration (SAMHSA) reveal how people living in the United States reported their experiences with mental health conditions, substance use, and the pursuit of treatment in 2021.

Among individuals ages 12 years and older, 61.2 million people used illicit drugs in 2021, most often marijuana, according to key findings from the National Survey on Drug Use and Health.

Additionally, 9.2 million people 12 years or older misused opioids in the past year, and 94% of people in that age group with a substance use disorder did not receive any treatment.

The survey also found that about 20% of adolescents in 2021 had a major depressive episode in the past year, with almost 75% reporting symptoms consistent with severe impairment. Nearly 25% of adults age 18 years and older had a mental illness in the past year in 2021, and that figure jumped to about 33% among adults aged 18 to 25 years. Roughly 13.5% individuals 18 to 25 years old reported both substance use disorder and any mental illness in 2021.

The report also found that 12.3 million adults had serious thoughts of suicide in 2021, while 3.5 million made suicide plans and 1.7 million attempted suicide. ■