FDA Panel Deems Common Over-the-counter Decongestant, Phenylephrine, As Ineffective

14 Sept 2023 • On September 12, the Nonprescription Drug Advisory Committee (NDAC) of the Food and Drug Administration (FDA) voted unanimously that phenylephrine, a popular oral nasal decongestant, is ineffective. The NDAC will now determine whether the drug's status as Generally Recognized as Safe and Effective (GRASE) should be revoked.

If the GRASE status is revoked, manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. The review found that the original studies used to support the efficacy of phenylephrine were inconclusive at best and contained potential methodological, statistical, and data integrity issues. The side effects of phenylephrine include headaches, insomnia, and nervousness. At higher doses, it can increase blood pressure. Revoking the GRASE status of phenylephrine would leave patients without an over-the-counter option.

According to the FDA review, "most consumers may simply need instruction on the alternatives, including how to obtain 'behind-the-counter' pseudoephedrine or to use alternative treatments, including intranasal decongestants (including intranasal phenylephrine), intranasal steroids, intranasal antihistamines, or intranasal saline products." Despite these complications, "there are a number of potential benefits that would be derived by changing the GRASE status of oral phenylephrine." These include avoiding unnecessary costs of taking an ineffective drug, potential allergic reactions and side effects, and the risks of patients taking a higher dosage.

Source: FDA | Read full story

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