The not-so-surprising reason these OTC decongestants will be banned

With cold and flu season approaching, you may be thinking about stocking up on your preferred decongestants and cold medicines.

The last thing you want is to be caught empty-handed when your sinuses are blocked, you can’t breathe and the pressure and pain knocks you down for the count.

But before you head to the pharmacy, I’m here to give you some news about recent developments in the world of cold remedies that may blow your mind — then we’ll work on how to blow that congestion right out of your nose…

Active ingredient in popular decongestants deemed ineffective

In the world of over-the-counter decongestants, many of the products we reach for contain the active ingredient phenylephrine (PE).

Phenylephrine is found in popular products such as Advil Sinus Congestion & Pain, Sudafed PE Nasal Decongestant, Tylenol Cold & Flu Severe, and many, many others.

But following an evaluation of clinical trial data in 2023, a panel of expert advisors for the U.S. Food and Drug Administration agreed that oral PE-based drugs are no better at reducing stuffiness than a placebo and recommended that oral PE decongestants be reclassified so that they are not falsely labeled as “effective.”

Now the FDA is taking action: As of November 2024, the FDA has proposed to remove oral phenylephrine, widely used in cold and cough syrups, as an active ingredient in over-the-counter drugs for nasal congestion.

According to Patrizia Cavazzoni, director of the administration’s Center for Drug Evaluation and Research (CDER), “It is the FDA’s role to ensure that drugs are safe and effective. 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.”

For now, companies may continue to market drug products containing oral phenylephrine as a nasal decongestant. However, the FDA will be providing manufacturers with an appropriate time table to either reformulate their drugs containing oral phenylephrine or remove such drugs from the market.

Safer choices for fighting congestion

There are some decongestant products containing PE that the FDA will allow to remain on the market, specifically nasal sprays that deliver the active ingredient into the bloodstream via a more direct route.

But when taken orally, too much of the medicine is broken down in the gut before it gets into the bloodstream to have any real effect.

This all leaves you with a couple of choices. You can switch to nasal sprays and see if PE works for you when pushed into your bloodstream, or you can try a natural alternative.

And there’s good reason to give the latter at least a try…

Due to the severity of sinus symptoms, many people suffering from chronic sinusitis have been reported to form addictions to chemical over-the-counter nasal sprays.

Active ingredients, including PE and another decongestant called Oxymetazoline, can not only lead to dependency but can cause damage to nasal passage membranes, leading to chronically inflamed nasal passageways — a condition known as rebound congestion — and cause recurring symptoms to worsen over time.

But when you can’t breathe and sinus pain and pressure make your head feel like it’s about to explode, what else can you do?

Nasal irrigation: A natural and chemical-free method is simply to irrigate the nasal passages with a saline solution. Nasal irrigation improves nasal mucociliary clearance while also removing mucus from the maxillary and ethmoid sinuses. Practicing nasal irrigation during the times of the year you’re most affected by sinus trouble can work as a preventative as well.

Nattokinase: Natto is a traditional Japanese superfood that contains a heavily studied enzyme, nattokinase, found to dissolve sinus pain and pressure. The enzyme has been found to shrink nasal polyps which can lock mucus inside sinus cavities, as well as thin mucus allowing better drainage.

Spicy foods: Did you know you can find nasal sprays made with capsaicin? That’s one way to make your nose run. Another is to eat spicy foods that open up your sinuses and let the mucus flow.

Ginger and turmeric: The anti-inflammatory properties of these spices help open up congested nasal passages by relieving the swelling. Try them in a hot tea and breathe in the steam while you allow it to cool down before sipping.

To cut your risk of sinus infections and nasal polyps, be sure to beef up your vitamin D3 and keep zinc on hand.

Sources:

Key Ingredient in Most Decongestants Doesn’t Work, Experts Say — Science Alert

NDAC Briefing Document: Oral Phenylephrine in the CCABA Monograph — FDA

U.S. FDA proposes ending use of popular decongestant present in cold medicines — Reuters