Key Points
In a long-sought move, the US Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant that the agency concluded last year is not effective at relieving stuffy noses...
Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter productsalso known as the OTC monograph..
Once removed, drugmakers will no longer be able to include phenylephrine in products for the temporary relief of nasal congestion...
Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant...
Last year, the FDA reevaluated the drug again, taking into consideration the new studies and taking a deeper look at the 14 studies from the 1950s to 1970s that earned phenylephrine its initial approval..
