News Release 

Flu vaccine associated with small increased risk for subdeltoid bursitis

Embargoed News from Annals of Internal Medicine

American College of Physicians

Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.

1. Flu vaccine associated with small increased risk for subdeltoid bursitis

Injection technique may be the key to limiting vaccine-associated bursitis risk

Abstract: https://www.acpjournals.org/doi/10.7326/M19-3176

Editorial: https://www.acpjournals.org/doi/10.7326/M20-3302

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Influenza vaccination was associated with a small risk for subdetltoid bursitis in a large retrospective cohort study, an association that was previously supported by clinical evidence from case reports. Education and training on proper injection technique could prevent this adverse event. Findings are published in Annals of Internal Medicine.

Subdeltoid bursitis, characterized by pain and loss of motion in the shoulder, occurs in about 1 percent of the U.S. population and is usually due to injury. In 2012, an Institute of Medicine report concluded that evidence supported a causal relationship between the injection of a vaccine and deltoid bursitis, however, epidemiologic evidence for this relationship was lacking.

Researchers from the Centers for Disease Control and Prevention (CDC) studied data from the Vaccine Safety Datalink, which contains health encounter data for 10.2 million members of 7 U.S. health care organizations, to estimate the risk for subdeltoid bursitis after influenza vaccination. Of 2, 943, 493 vaccinated persons included in the analysis, the researchers found 16 cases of symptom onset in the risk interval and 51 cases of symptom onset in the control interval. The attributable risk was 7.78 additional cases of bursitis per 1 million persons vaccinated.

The authors of an accompanying editorial from Emory University School of Medicine and the University of Pennsylvania point out that vaccination technique seems to be a common theme in this study as well as in previous studies. Both needle placement and needle length matter. Hence, a technique "tune-up" could help to eliminate this adverse reaction among persons having vaccinations.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with the lead author Elisabeth M. Hesse, MD, MTM&H, please contact Martha Sharan at liu4@cdc.gov. To reach the editorialist, Sandra Fryhofer, MD, please contact her directly at sandra@drsandrafryhofer.com.

2. African Americans under-represented in cancer medication trials

Abstract: https://www.acpjournals.org/doi/10.7326/M20-0410

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African Americans are under-represented in all clinical trials that led to FDA approval of cancer medications in the United States, even for medications addressing cancers more common in African Americans, such as multiple myeloma and prostate cancer. While response to approved medications may be different between African Americans and Caucasians, they are still used on all patients, regardless of ethnicity. A brief research report is published in Annals of Internal Medicine.

Clinical trials have shaped the treatment paradigm for most types of cancer, and the results from these studies are generally applied equally to all races and ethnicities. However, African Americans may not participate in clinical trials because of lack of information; concern about trial conditions; dislike of the randomization required for trial participation; suspicion of health care providers' attitudes; and distrust of medical research related to historical events, such as the Tuskegee study.

Researchers from Baylor College of Medicine studied participation data on Drugs@FDA to determine whether those influences have affected participation of African American persons in pivotal trials of cancer medications submitted to the U.S. Food and Drug Administration (FDA) for approval. They found that between 2014 and 2018, a total of 61,763 patients enrolled in clinical trials that resulted in subsequent FDA approval for cancer drugs. The proportion of African American persons enrolled in these trials was just 7.44 percent. The participation to prevalence ratio, or PPR, was 0.31 for all cancers and was even lower in cancers more common in African Americans. According to the researchers, these findings suggest that initiatives are needed to increase African American participation in drug trials.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with the lead author, Samer Hadidi, MD, MS, can be contacted directly at hadidi@bcm.edu.

3. Risk for Nephrogenic Systemic Fibrosis is rare with newer gadolinium-based contrast agents, but evidence is lacking for patients with kidney disease

Abstract: https://www.acpjournals.org/doi/10.7326/M20-0299

URL goes live when the embargo lifts

Nephrogenic systemic fibrosis (NSF) is a rare potential side effect of newer gadolinium-based contrast agents (GBCAs), but evidence is lacking among patients with acute kidney injury and those with risk factors for chronic kidney disease. As such, based on evidence synthesized from existing studies, the researchers advise caution when using these agents in populations with kidney disease and suggest that more research is needed for these patients. A systematic review and evidence synthesis are published in Annals of Internal Medicine.

NSF is a debilitating and often fatal condition caused by collagen deposition in soft tissues and internal organs, such as the heart, liver, and lungs. Nephrogenic systemic fibrosis is associated with exposure to GBCAs administered during magnetic resonance imaging or angiography scans and has no definitive treatment. In 2007, the U.S. Food and Drug Administration (FDA) released warnings about the use of GBCAs in recognition of the substantial risk for NSF with their use. Newer GBCAs are thought to carry markedly lower NSF risk, but the relative safety of newer compared with older GBCAs and the degree of kidney dysfunction that confers risk for NSF is unclear.

Researchers from Duke University School of Medicine reviewed 32 published articles to synthesize evidence about NSF risk with newer versus older GBCAs across the spectrum of kidney function. Of the 32 articles, 20 articles allowed for assessment of NFS risk after exposure to newer GBCAs and 12 allowed for comparison of NSF risk between newer and older GBCAs. The authors found that although NSF occurrence after exposure to newer GBCAs is very rare, limited evidence suggests that additional studies in patient populations with mild kidney disease would substantially change these conclusions. Thus, Lunyera and colleagues concluded that caution in the use of GBCAs in patients with severely impaired kidney function and acute kidney injury remains prudent, because the exact clinical factors contributing to NSF risk in these subpopulations are still unknown.

Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with the lead author, Joseph Lunyera, MBChB, MSc, please contact Cassie Meyer at Cassie.Meyer@va.gov or Clare Il'Glovine at clare.ilglovine@duke.edu.

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