I heard that the FDA says decongestants don’t work. Should I stop taking them?

A: Decongestants containing phenylephrine don’t work, but those containing pseudoephedrine are still very effective.

Sep 22, 2023

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I heard that the FDA says decongestants don’t work. Should I stop taking them?

A: Decongestants containing phenylephrine don’t work, but those containing pseudoephedrine are still very effective.

It might not be cold season quite yet, but a recent FDA review on a common decongestant called phenylephrine might have you worried that one of your favorite over-the-counter remedies should be tossed out.

Walking down the pharmacy’s “cough and cold” aisle can be overwhelming. Over 200 unique products touting different relief profiles are enough to make your head spin. One study found that despite the illusion of variety, these “unique” products consist of only about eight actual ingredients (when you exclude pain medications).

These ingredients fall into four classes:

*anti-tussives (reduce cough)
*expectorants (help cough up mucus)
*antihistamines (reduce allergy response) and
*decongestants (reduce congestion).

Both phenylephrine and pseudoephedrine are considered decongestants. Last week, the FDA advisory committee specializing in over-the-counter medication reviewed all available data on phenylephrine since 1994. They found phenylephrine taken by mouth at the current over-the-counter dosage is not effective as a nasal decongestant. Two research pharmacists from the U of Florida first petitioned the FDA to remove the drug in 2015. Although we’ll never know if this is what set the regulatory wheels in motion, maybe sometimes, the system works!

Phenylephrine, often abbreviated PE, is found in medications with that designation (e.g., Sudafed PE) but can also be found in products without it, such as in brands like Dayquil/Nyquil, Theraflu, and Vicks, among others. Unlike pseudoephedrine, which is typically kept behind the pharmacy counter or in a locked case to discourage misuse, medications containing phenylephrine can be picked up without speaking to pharmacy staff.

Pseudoephedrine is very effective. You’ll most often find it in products with the “D” attached (Zyrtec/Claritin/Mucinex “D,” classic Sudafed, etc.). It’s great for relieving sinus congestion and is a great alternative if you’ve been diagnosed with a sinusitus but your clinician recommends delaying antibiotic therapy.

Even though pseudoephedrine can provide symptom relief for sinus pain and pressure, there are some people who should not or might not want to take it:

*Children: There is little evidence that pseudoephedrine is effective for young children (frontal sinuses do not develop until age 7) and side effects are more common in kids. Many pediatric clinicians (myself included) don’t recommend it for under 12s for these reasons.

*Those with chronic medical conditions such as Type 2 Diabetes, high blood pressure, heart disease or overactive thyroid, as the stimulant and vasoconstriction (narrowing of blood vessels) properties of pseudoephedrine can affect these conditions.

*Breast/chestfeeding parents: Pseudoephedrine may temporarily lower milk supply and/or cause temporary fussiness in nursing infants.

Bottom line: Next time you stock up on cold medicine, remember to read the label. Phenylephrine may be out, but pseudoephedrine is still a good option for decongestion relief.

Stay safe, stay well,

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