In response to a shortage of liquid ibuprofen, the US Food and Drug Administration is temporarily allowing manufacturers to manufacture and distribute non-FDA-approved drugs to relieve fever and pain
27 January 2023
Due to drug shortages, the US Food and Drug Administration (FDA) is temporarily allowing medical manufacturers to produce unapproved alternatives to liquid ibuprofen for use in hospitals. This process, called compounding, generates near-identical substitutes by mixing or modifying pharmaceutical ingredients, and can ease painkiller shortages in hospitals.
For months, supply chain problems and increased demand have created drug shortages in many countries, including the US, UK, Canada and Australia. “Covid, flu and RSV have really taken a toll [on supplies]”, says Lisa Mulloy of Northwell Health in New York. The shortage has left hospitals and retailers struggling to obtain liquid versions of ibuprofen, which is used to reduce fever and pain in children and adults who cannot swallow pills or tablets.
“We’ve completely moved away from the liquid preparations because the products are simply not available,” says Emily Benefield of Seattle Children’s Hospital, which ran out of supplies about two months ago. To continue treating patients, she and her colleagues have resorted to mixing ibuprofen themselves by crushing tablets and mixing them with liquid – a time- and resource-consuming process, she says.
To alleviate some of this burden, the FDA announced on January 20 that it would allow designated manufacturing facilities to mix ibuprofen in large batches for distribution to hospitals. Although these products are not FDA approved, they do comply with certain FDA regulations, such as the use of antibacterial preservatives and sterilized water. Manufacturers must also screen all ingredients for contaminants.
But without FDA approval—which requires clinical trials to determine a drug’s safety and efficacy—these products have greater safety risks and may be less effective. “That said, we continue to have good success in treating our patients’ pain and fever with these compounded products,” says Benefield.
Mulloy says this is the first time she has seen the FDA recommend compounded ibuprofen products. “The guidance really illustrates how big a problem this is [shortage] is, says Benefield. “Compounding is something best avoided unless absolutely necessary.”
The problem is that compounded products cannot be sold in retail pharmacies, that is where there is the greatest shortage, says Mulloy. The FDA said it is working to increase retail access, but gave no indication of how it plans to do so.
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