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Corticosteroids & Outpatient Utilization

Basic Details
Status
Complete
Last Updated
Tuesday, September 26, 2023
Original Posting Date
Health Outcome(s)
outpatient utilization
Purpose
Drug Use
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Regulatory Determination / Use

In June 2020 the United Kingdom Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial, reported benefit from dexamethasone use in severely ill hospitalized patients with COVID-19, but potential harm in patients not requiring oxygen supplementation. As a result, in October 2020, the National Institutes of Health (NIH) issued guidelines advising against the use of systemic corticosteroids in non-hospitalized COVID-19 patients. The Rapid Sentinel Distributed Database (SDD) was used to describe the demographic and clinical characteristics of U.S. non-hospitalized patients with COVID-19 who initiated systematic corticosteroids and those who did not from April 2020 to July 2021. Additionally, descriptive information was generated on the proportion of corticosteroid initiators who were hospitalized within 30 days of initiation.*  

There were 766,105 eligible COVID-19 patients (median age 48.5 years [standard deviation, 19.9 years]), 9.4% of whom received corticosteroids in an outpatient setting within 14 days of COVID-19 diagnosis. Treatment often started on the day of COVID-19 diagnosis (51.3%), largely through pharmacy dispensings rather than during medical encounters. Corticosteroid use increased over time from 2.2% initiating in April 2020 to 13.8% initiating in July 2021. Among those who received corticosteroids in an outpatient setting, 11.1% were hospitalized (COVID-19 in any diagnostic position) within 30 days of initiation.  

An early version of these analyses was presented to the NIH COVID-19 Treatment Guidelines Panel (April 2021). Later, updated analyses were published in the Journal of the American Medical Association (JAMA) (April 2022). The Centers for Disease Control and Prevention (CDC) subsequently issued a health advisory citing these data and alerting physicians and the public that systemic corticosteroids are not recommended for patients with mild to moderate COVID-19 who do not require supplemental oxygen.  

 

*In addition to the Rapid SDD, the FDA conducted parallel analyses in three other data sources. Results here pertain only to Sentinel.

Result(s) (2)
Outpatient Corticosteroid Use in Patients With COVID-19: A Descriptive Analysis Outpatient Corticosteroid Use in Patients With COVID-19: An Updated Descriptive Analysis
Related Publication(s) and/or Presentation(s) (3)
Publication: Systemic Corticosteroid Use for COVID-19 in US Outpatient Settings From April 2020 to August 2021 Centers for Disease Control and Prevention (CDC) Health Alert Network (HAN) Health Advisory: Updated Information on Availability and Use of Treatments for Outpatients with Mild to Moderate COVID-19 Who are at Increased Risk for Severe Outcomes of COVID-19 Presentation: Systemic Corticosteroids for COVID-19 in U.S. Outpatient Settings