In response to a shortage of liquid ibuprofen, the US Food and Drug Administration is temporarily allowing manufacturers to produce and distribute non-FDA approved drugs for relieving fever and pain
27 January 2023
Due to medication shortages, the US Food and Drug Administration (FDA) is temporarily allowing medical manufacturers to produce non-approved alternatives to liquid ibuprofen for use in hospitals. This process, called compounding, generates nearly identical substitutes by mixing or modifying pharmaceutical ingredients, and could alleviate the painkiller shortage in hospitals.
For months, supply chain issues and increased demand have created medication shortages in many countries including the US, the UK, Canada and Australia. “Covid, the flu and RSV have really put a strain [on supplies],” says Lisa Mulloy at Northwell Health in New York. The shortages have 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 have moved completely away from the liquid preparations because the products are just not available,” says Emily Benefield at Seattle Children’s Hospital, which ran out of its supply about two months ago. To continue treating patients, she and her colleagues have resorted to compounding ibuprofen themselves by crushing tablets and mixing them with liquid – a time- and resource-intensive process, she says.
To alleviate some of this burden, the FDA announced on 20 January that it would allow designated manufacturing facilities to compound ibuprofen in large batches to distribute to hospitals. While these products are not FDA-approved, they abide by certain FDA regulations, such as using antibacterial preservatives and sterilised water. Manufacturers must also screen all ingredients for contaminants.
However, without FDA approval – which requires clinical trials to determine a drug’s safety and efficacy – these products carry greater safety risks and may be less effective. “That being said, we are still having good success treating our patients’ pain and fever with these compounded products,” says Benefield.
Mulloy says this is the first time she’s seen the FDA recommend compounded ibuprofen products. “The guidance really illustrates how big of a problem this [shortage] is,” says Benefield. “Compounding is something that is best to avoid unless truly necessary.”
The issue is that compounded products cannot be sold in retail pharmacies, which is where the greatest shortages are, says Mulloy. The FDA said it is working to increase retail access but didn’t provide any indication of how it plans to do so.
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