Some children stopped using inhaled steroids after a popular asthma inhaler was discontinued in late 2023 instead of switching to a new product, according to a new study.
“Our findings suggest the withdrawal of Flovent disrupted inhaled steroid therapy in children, potentially increasing their risk of asthma attacks,” lead author Kao-Ping Chua, M.D., Ph.D., FAAP, said in a press release. He is a pediatrician and researcher at University of Michigan Health C.S. Mott Children's Hospital and the Susan B. Meister Child Health Evaluation and Research Center.
GSK discontinued corticosteroid inhaler Flovent HFA (fluticasone propionate inhalation aerosol) at the end of 2023. While it continued to produce an authorized generic with a partner company, pediatricians raised concerns about some insurers not covering the generic and others not considering it a preferred treatment, which can lead to higher copays and the need for prior authorizations that delay access. The AAP urged payers to cover alternative medications and remove unnecessary prior authorizations and shared concerns with federal health officials.
Researchers aiming to study the impact of the Flovent discontinuation gathered data on inhaled steroid prescriptions for children and teens from a database that includes 92% of prescriptions from U.S. pharmacies. The findings were published in “Changes in Inhaled Steroid Dispensing to Children After Withdrawal of Brand-Name Fluticasone Propionate” (Chua K, et al. JAMA. April 26, 2025), which was scheduled to be presented on Saturday at the Pediatric Academic Societies meeting in Hawaii.
The team found that among children who had Flovent dispensed to them in the last quarter of 2021 or 2022, about 35% did not have an inhaled steroid dispensed in the nine months after. For children who received Flovent in late 2023 just before the withdrawal, about 41% did not go on to have an inhaled steroid dispensed in the following nine months.
They also looked at a control group of children who used inhaled steroids other than brand name Flovent. Their rate of discontinuing steroid treatment stayed nearly the same before and after Flovent was withdrawn at 39% and 38%, respectively.
The increase in Flovent users stopping inhaled steroids was greater for children under 6 years than for adolescents and for children insured with Medicaid compared to those with commercial insurance, according to the study. Authors noted young children and Medicaid patients are “groups at elevated risk of asthma morbidity.”
The study did not assess how many of the patients stopped using inhaled steroids because they were no longer needed, but authors said high dispensing rates at baseline indicate “lack of need was not the only factor.”
They also called out the January 2024 elimination of caps on rebates manufacturers pay to Medicaid programs as a possible reason GSK discontinued Flovent at that time.
“Our findings suggest that the elimination of the Medicaid rebate cap had unintended consequences for children with asthma,” Dr. Chua said, adding medications for diabetes and infections also may be impacted.
“If other brand name drugs are withdrawn due to elimination of the rebate cap, policymakers should proactively implement interventions to prevent therapy disruptions, such as ensuring insurer coverage of alternative drugs,” he said.
