FDA solicits public comments on phenylephrine-based decongestants

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The U.S. Food and Drug Administration held a Non-prescription Drug Advisory Committee meeting last week to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter cough and cold products that are indicated for the temporary relief of congestion, both as a single-ingredient product and in combination with other ingredients.

The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data does not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. 

However, neither FDA nor the committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose.

Advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision, it said. The FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine, according to the agency.

WHAT'S THE IMPACT?

Many OTC medicines, including phenylephrine, are sold because they have an ingredient the FDA generally recognizes as safe and effective (GRASE) when used as recommended on the product labeling, which is documented in an "OTC monograph." 

If the FDA determined that oral phenylephrine is not effective, the agency would first issue a proposed order removing phenylephrine from the monograph. The public would then have the opportunity to comment on the proposed order. 

If, after considering the comments, the FDA continued to conclude phenylephrine is not effective, the agency would issue a final order removing the ingredient from the monograph, and phenylephrine would no longer be considered GRASE. The agency would then work closely with manufacturers to reformulate products as needed to help ensure the availability of safe and effective products to treat symptoms of colds or allergies.

The FDA pointed out that there are a range of products that are available for temporary relief of congestion symptoms due to allergies or a common cold. Some of these products only contain phenylephrine.

Other products contain phenylephrine and another active ingredient – such as acetaminophen or ibuprofen – that treats symptoms other than congestion, like headaches or muscle aches, and the presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms, the FDA said. Because a variety of different drug products may be sold under the same brand name, consumers should always read the drug facts label to determine which ingredients are in a medication, as well as important warnings and directions for use.

Phenylephrine is also an ingredient in nasal sprays to treat congestion. The advisory committee's discussion and recommendations only related to orally administered phenylephrine, and not the nasal spray form. Nasal sprays containing phenylephrine will not be affected by any possible actions taken for phenylephrine in orally administered products, such as tablets or capsules, the FDA said.

THE LARGER TREND

"FDA remains committed to using all available tools to assure the safety and efficacy of FDA-regulated drug products and to help ensure that Americans have access to medicines that are safe and effective for their labeled uses," the agency said.
 

Twitter: @JELagasse
Email the writer: Jeff.Lagasse@himssmedia.com