Conventional over-the-counter cold meds promise cold symptom relief right on the front of their packaging, but U.S. Food and Drug Administration (FDA) advisors have stated that an active ingredient in many popular cold medicines is not effective in relieving congestion when taken orally. An advisory panel for the FDA unanimously concluded recently that phenylephrine, a common active ingredient in decongestants like Dayquil, Mucinex, Sudafed and others, does not work as advertised.1
The FDA panel vote comes just before the panel is faced with another important decision that would affect the availability of popular over-the-counter drugs to treat cold and influenza-like-illness during the fall and winter seasons when people come down with respiratory infections, including influenza: whether or not to recommend the banning of the ingredient and ask FDA officials to order the removal of products containing it from pharmacy shelves altogether. The decision could impact consumer demand and drive rushed reformulations from drugmakers.1
As of last month, CVS had already begun voluntarily removing products containing the phenylephrine from their shelves, according to a company spokesperson. They added that they will continue to offer other cold and cough products that do not contain phenylephrine to meet consumer demand, especially as cold and flu season is underway. Drugs like Sudafed drive a staggering $2.2 billion market for oral decongestants.2
Products that contain phenylephrine comprise four-fifths of that market. Additionally, sales of drugs containing phenylephrine saw a 30 percent increase in sales from 2020 to 2021. Kenvue, a consumer health company owned by Sudafed manufacturer Johnson & Johnson, has declined to comment on the FDA’s vote or CVS’ decision to remove products from their shelves.2
Industry Trade Group Disputes FDA Advisory Panel Conclusions About Phenylephrine
The Consumer Healthcare Products Association (CHPA) warns that the FDA’s decision could have “significant unintended negative consequences,” particularly for consumers. The industry trade group, which advocates for the personal healthcare industry and represents manufacturers and distributors of over-the-counter drugs, worries that removing conventional household cold medicines from pharmacy shelves will make it harder for consumers to self-treat mild illnesses.3
In a Sept. 7, 2023 statement, the CHPA said that “data from multiple clinical trials demonstrating effectiveness and decades of in-market experience” prove phenylephrine is beneficial and plays a critical role in public health. The group added that an inability to purchase these conventional OTC medications could result in consumers delaying or foregoing treatment which could lead to worsened clinical outcomes and an added burden on an already-strained healthcare system.4
Still, the FDA panel’s vote of no confidence in the drug’s effectiveness comes more than a decade after researchers began questioning the drug. Results from one 2007 study found “insufficient evidence that oral phenylephrine is effective for nonprescription use as a decongestant.” The more that 10-year-old study concluded that, “The Food and Drug Administration should require additional studies to show the safety and efficacy of phenylephrine.” 5
What About All the Bad Side Effects of Phenylephrine?
The current conversation revolves around whether or not phenylephrine is effective, but a more pressing question lingers: is the ingredient safe? Most nasal decongestants’ warning labels are clear: “Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.”6
According to the website Drugs.com, phenylephrine, even when taken orally, may cause unwanted effects such as blurred vision, chest pain, tightness, or discomfort, difficult or labored breathing, dizziness, fainting, fast/irregular heartbeat, headache, nausea, vomiting, anxiety, shoulder/jaw/arm/neck pain, and more. In one study, the drug “significantly increased blood pressure, stroke volume, and total peripheral resistance compared to the vehicle group. Moreover, heart rate was significantly decreased following phenylephrine administration.”7 8
Phenylephrine Remained Unchallenged on Pharmacy Shelves for Nearly 50 Years
Historically, today’s “safe and effective” label could be tomorrow’s FDA recall which can, in many cases, mean life or death for trusting consumers. Phenylephrine was first FDA-approved in 1976 and became more widely used after it was discovered that phenylpropanolamine, a widely used decongestant at the time, caused brain bleeds.
Fast forward 47 years and an advisory committee of the same federal regulatory agency, which approved phenylephrine as safe and effective, has done an about-face, announcing that the drug is – and always was – ineffective. This error has left consumers to, for almost five decades, incur the risks and side effects of an ineffective drug for relief of symptoms that never came.9
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1 Jewitt C et al. A Decongestant in Cold Medicines Doesn’t Work at All, an F.D.A. Panel Says. The New York Times Sept. 12, 2023.
2 Constantino AK. CVS to pull certain cold medicines containing decongestant phenylephrine from store shelves. CNBC Oct. 19, 2023.
3 Cerullo M. Ineffective ingredient could make Dayquil, Sudafed and others disappear from store shelves. CBS News Sept. 12, 2023.
4 Press Release. Statement on the September 11-12, 2023, Meeting with FDA NDAC to Evaluate Efficacy of Oral PE. Consumer Healthcare Products Association Sept. 11, 2023.
5 Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother March 2007; 41(3): 381-90.
6 Harvard Health Publishing. Don’t let decongestants squeeze your heart. Apr. 11, 2023.
7 Drugs.com. Phenylephrine Side Effects. May 1, 2023.
8 Rajanathan R, Pedersen TM, Thomsen MB, Botker HE, Matchkov VV. Phenylephrine-Induced Cardiovascular Changes in the Anesthetized Mouse: An Integrated Assessment of in vivo Hemodynamics Under Conditions of Controlled Heart Rate. Front Physiol Feb. 17, 2022; 13: 831724.
9 Weiss H. With the Decongestant SNAFU, the FDA Tries Something New. TIME Sept. 14, 2023.