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  • Writer's pictureP.K. Peterson

Acute Sinusitis—Don’t Reach for Antibiotics or Decongestants

“For consumers it’s a hard sell when the FDA allows a drug to be on the market and then takes it away from us. But it’s actually a demonstration of how the FDA works. When the FDA removes a drug from the market, they’re protecting the health of the public—and they’re protecting truth in medicine.”

- Mikkael A. Sekeres, M.D., Miller School of Medicine, University of Miami


“The young physician starts life with 20 drugs for each disease, and the old physician ends life with one drug for 20 diseases.”

- Sir William Osler, Canadian physician, father of modern medicine




Adults typically contract two or three viral upper respiratory tract infections (URIs), aka colds, a year, and rhinorrhea (a runny nose) is a ubiquitous symptom. With the exceptions of influenza virus and SARS-CoV-2 virus, no antiviral drugs are available to treat the cause of other viral URIs. Many people turn to oral over-the-counter (OTC) drugs in an attempt to relieve the symptoms of a URI such as nasal stuffiness and rhinorrhea.


On September 12, 2023, a Federal Drug Administration (FDA) advisory panel unanimously agreed that the decongestant, phenylephrine—found in many OTC oral cough and cold remedies, like Sudafed, Dayquil, Mucinex, Tylenol Sinus, and Advil Sinus—is ineffective in treating congestion. In this week’s Germ Gems post, I review the topic of acute sinusitis and discuss the ramifications of the FDA’s decision in this post-decongestant era.

What is acute sinusitis? Acute sinusitis (aka rhinosinusitis) refers to inflammation of the sinuses with symptoms lasting less than four weeks. It is an extremely common condition, accounting for approximately 30 million primary care visits and $11 billion in healthcare expenditure annually. Acute sinusitis is most commonly caused by infectious agents such as viruses, bacteria, or fungi. In some cases, it is provoked by an inflammatory response in the sinuses to an allergen.


Viruses, including rhinovirus, adenovirus, influenza virus, parainfluenza virus, and coronaviruses, including SARS-CoV-2, the cause of COVID-19, are by far the most common etiology of acute sinusitis. Bacteria such as Streptococcus pneumoniae and Haemophilus influenzae can also cause acute rhinosinusitis—a condition referred to as acute bacterial rhinosinusitis (ABRS). Fungal infections of the sinuses although serious are quite rare; most are chronic and occur in immunocompromised or diabetic patients.


Acute rhinosinusitis is a clinical diagnosis with these cardinal symptoms: purulent (thickened, sometimes yellowish) nasal discharge, accompanied by nasal obstruction or facial pain/pressure/fullness. Most of the cases result from viruses and are self-limiting, that is they go away on their own. But if these cardinal symptoms persist beyond ten days or if they worsen after an initial period of improvement (called “double worsening”) and include a high fever or other severe symptoms, ABRS should be considered.


Treatment of acute rhinosinusitis. Viruses cause the vast majority of cases of acute rhinosinusitis. Antibiotics (antibacterial drugs) do not work against viruses and should not be prescribed for treatment. Antibiotic overprescribing is an important factor underlying the emergence of “multiply antibiotic resistant bacteria.” (I addressed the magnitude of this challenge in my April 13, 2022, Germ Gem post, “Antimicrobial Resistance; The Elephant in the Pandemic Room.”) Equally important, antibiotics have side effects, some of which are severe or even life-threatening. Plus, some are quite expensive.

Considerations about when to use antibiotics for ABRS, as well as when to obtain radiographic tests and to seek otolaryngology consultation require a thorough discussion between primary care providers and their patients. (While an estimated 16% of adults are diagnosed with ABRS annually, many experts consider this to be an overestimate.)


The case against oral decongestants. In 1976, the FDA originally designated oral decongestants containing phenylephrine as “safe and effective.” According to a September 14, 2023, article in Time Magazine by science journalist Haley Weiss titled, “With the Decongestant SNAFU, the FDA Tries Something New,” that was an era when the FDA was “greenlighting drugs that had been on the market for years before the agency had established any efficacy standards.”


Traditionally, the FDA pays closer attention to drug safety than efficacy. Phenylephrine’s safety profile is quite benign (side effects include mild gastrointestinal upset, trouble sleeping, dizziness, and increased heart rate). The evidence, however, existed for some time suggesting that when taken orally, phenylephrine didn’t work. But it wasn’t until recently that the FDA sponsored randomized control trials to evaluate the efficacy of phenylephrine in oral decongestant. These trials found that phenylephrine was ineffective as an oral medication.


The FDA was protecting truth in medicine when it made its announcement about the ineffectiveness of the OTC oral decongestants containing phenylephrine. The sale of these OTC oral remedies brings in approximately $1.8 billion revenue per year. When you consider that there are over 300,000 nonprescription drug products marketed in the U.S., a majority of which are regulated under an FDA OTC monograph, if the FDA’s decision to “decondition” phenylephrine because of its lack of efficacy sets a precedent, there’s going to be a lot of work to do to establish the efficacy of other OTC drugs. (For an excellent assessment of the situation, I recommend reading Dr. Keren Landman’s article, “Why are so many useless cold medicines littering pharmacy shelves?” on September 15, 2023 in Vox News.)

What to do instead of taking oral phenylephrine. The FDA’s recent opinion only deals with the effectiveness of oral phenylephrine preparations. It does not include phenylephrine preparations administered through the nose, like drops and sprays. It’s thought such preparations are more likely to reduce congestion because they’re not metabolized in the body before getting to the nasal and sinus cavities.


I’m a medicine nihilist, however, when it comes to treating the symptoms of the common cold. Most often, Mother Nature does her job and your immune system kicks in clearing up your nasal and sinus passages. One just has to be a patient patient.

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Main Page images courtesy of Shuxian Hu, MD. Dr. Hu is a scientist in the Neuroimmunology Research Laboratory at the University of Minnesota.

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