Health Watch: FDA updates oral decongestant recommendations – USC News & Events

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Posted on: September 26, 2023; Updated on: September 26, 2023
By
Gregory Hardy, [email protected]

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On Tuesday, September 12, 2023, an FDA advisory panel unanimously voted that the decongestant
phenylephrine is ineffective as an oral over-the-counter cold med and can be considered
a placebo.

Patricia H. Fabel, clinical associate professor of pharmacy and executive director
of the Kennedy Pharmacy Innovation Center, explains the phenylephrine fallout and
offers guidance ahead of cold and flu season.

Background: Phenylephrine became the primary ingredient in over-the-counter cold meds after a
2006 law limited access to pseudoephedrine, which can be used as an ingredient for
methamphetamine. It is present in more than 200 cold remedy products worth nearly
$2 billion annually in sales. 

To most pharmacists, this isn’t news. We’ve kind of always known that phenylephrine
is not the best agent for congestion over the counter, that pseudoephedrine is much
better.

Why it matters: The FDA could decide to ban the ingredient. While oral phenylephrine doesn’t work
as a decongestant for most people, there are other active ingredients that are effective.
Nasal sprays that contain phenylephrine can work, but as a short-term solution. 

In the meantime, this season’s cold and flu sufferers will need to make informed decisions
as to whether products that contain phenylephrine are worth consuming. 

Products might become harder to find as the FDA weighs pulling formulations off the
market or phasing out medications.

“I hope there will be more information soon about the availability of cough and cold
and flu products, as the FDA makes decisions on how they’re going to change that,”
Fabel says.

What to know: Pseudoephedrine has safety concerns, Fabel notes. “It’s more likely to have side
effects, including dizziness, headaches, difficulty sleeping and elevated blood pressure. There’s also the abuse potential with pseudoephedrine.”

Additionally, pharmacists caution the use of nasal sprays. “You can have pretty severe
rebound congestion from the nasal decongestants, and there are still some safety concerns
with them,” says Fabel. “Depending on your other medical conditions, we may steer
you in a different direction.” 

Possible alternatives:

• Saline sprays and rinses are the safest over–the–counter options for nasal symptoms and are appropriate for all ages. However, it is important to only use commercially available normal saline products or distilled water, never tap water.
• Nasal decongestants that contain phenylephrine or oxymetazoline may be appropriate
  for some patients, short–term (less than three days).
• Nasal corticosteroids that contain fluticasone, triamcinolone, mometasone or budesonide and the nasal antihistamine, azelastine, are quite effective for nasal congestion related to hay fever and allergic rhinitis.
• Oral antihistamines help with some nasal symptoms (sneezing, runny nose) but are unlikely to relieve congestion.

Bottom line: “Talk to your pharmacist now, before you get sick, about appropriate medications,”
Fabel says. “They know what’s going on with meds and can help determine what is appropriate
for you to use based on your medication and medical history.”

 

 

USC’s Health Watch series helps readers deepen their understanding of the latest health
recommendations and news through the expertise of our clinical faculty.

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