If FDA swipes common decongestant, supply issues expected

If the FDA removes the approval of phenylephrine, a common ingredient used in decongestants that research shows is ineffective, a new study says supply chain disruptions are likely.

The FDA is mulling whether to pull the oral drug, which was approved in 1976. CVS stopped selling cold and flu medicines with phenylephrine in October, a month after an FDA advisory panel agreed the drug does not help with nasal congestion. 

Its efficacy has been in question for years, dating back to 2007. 

But, new research points out, the ingredient was more popular in sales compared to the only alternative therapy, pseudoephedrine. Researchers from the University of Pittsburgh School of Medicine investigated pharmaceutical sales from 2012 to 2021 among chain, independent, mail service and nonretail pharmacies. 

During that time, pharmacies bought 19.8 billion units of phenylephrine and 13.2 billion units of  pseudoephedrine. The drug's popularity could cause supply chain issues, the researchers said, since phenylephrine is usually combined with other ingredients as "multi-symptom products."

Pseudoephedrine is typically its own product. 

"If the FDA follows its advisory board recommendation and [removes the approval of] oral phenylephrine," they concluded, "reformulation of all phenylephrine-containing products would be required, which could have ramifications for supply chain."

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