What is oral phynylephrine and why does the FDA want to remove it from cold medicine?

The ingredient has been used for decades by millions of Americans

The U.S. Food and Drug Administration (FDA) is proposing to remove a common ingredient in nasal decongestants used by millions of Americans, citing data that shows it’s not effective.

Oral phenylephrine is used in over-the-counter products like Sudafed and Dayquil to help temporarily relieve the common symptom of colds and allergies. Phenylephrine has been sold for more than 75 years, predating the agency’s own regulations on drug effectiveness.

“It is the FDA’s role to ensure that drugs are safe and effective,” Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

Signage is seen outside of the Maryland headquarters of the US Food and Drug Administration (FDA) in August of 2020. The agency is proposing to remove oral phenylephrine from commonly-used nasal decongestants. (REUTERS/Andrew Kelly/File Photo)

For now, companies may still market products containing oral phenylephrine as a nasal decongestant. Only a final order will affect what products can be marketed. Some products only contain oral phenylephrine as a single, active ingredient, and others contain oral phenylephrine and another active ingredient.

The FDA notes the proposed order is not based on safety concerns, and that the presence of oral phenylephrine in these medicines does not affect how other active ingredients treat symptoms. In addition, its action is only related to orally administered phenylephrine, and not the nasal spray form.

Last fall, the FDA held a meeting to discusss the status of oral phenylephrine, determining that the leading decongestant is no better than a dummy pill. Studying phenylephrine at higher doses is not an option because it can raise blood pressure to potentially dangerous levels.

The FDA’s recent proposal drew swift reaction from the Consumer Healthcare Products Association, which noted that the ingredient is the only oral over-the-counter decongestant available without restrictions.

Sudafed and other common nasal decongestants containing pseudoephedrine are on display at a pharmacy in Edmond, Oklahoma, in January 2005. Phenylephrine became the main drug in over-the-counter decongestants when medicines with pseudoephedrine were moved behind pharmacy counters. ((AP Photo, File))

“CHPA is disappointed in FDA’s proposal to reverse its long-established view of oral PE. For decades, people have relied on oral PE to relieve their nasal congestion,” said CEO Scott Melville. “We believe Americans deserve access to safe and effective OTC medicines and the option to choose the products they prefer for self-care.”

Drugmakers Proctor & Gamble and Kenvue did not immediately reply to The Independent’s request for comment on the matter.

Phenylephrine became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters.

With reporting from The Associated Press