FDA Panel Finds Oral Phenylephrine Ineffective in Cold and Flu Medications

As the chill of fall and winter approaches, the cold and flu season brings unwelcome sniffles and congested noses. 

For years, many have relied on over-the-counter products containing phenylephrine to find relief. 

However, a recent unanimous decision by an advisory committee to the US Food and Drug Administration (FDA) in September 2023 may leave consumers surprised and searching for alternatives. 

This advisory committee concluded that phenylephrine, a common active ingredient in various cold and flu remedies, offers no more relief than a placebo when taken orally. 

As the FDA considers the implications of this decision, it’s essential to explore alternative options for managing cold and flu symptoms effectively.

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The Phenylephrine Predicament

Phenylephrine, whether in oral tablets, liquids, or nasal sprays, has long been a go-to remedy for nasal congestion due to colds and allergies. 

It’s essential to note that phenylephrine became widely available after another popular decongestant, pseudoephedrine, became regulated and moved behind pharmacy counters in 2006.

The latest 2023 advisory panel’s conclusion is not the first time phenylephrine’s effectiveness has been scrutinized.

 A 2007 panel also raised concerns but called for further studies. Subsequent research demonstrated that oral phenylephrine is inactive in the gut, explaining its limited efficacy.

It’s worth noting that there have been no safety issues associated with oral phenylephrine alone. 

However, the concern lies in consumers investing in products that provide no more benefit than a placebo, leading to a placebo effect, where individuals may perceive improvement even with inactive ingredients.

While the FDA is yet to take official action regarding phenylephrine, exploring alternative options for nasal congestion relief is prudent. 

Fortunately, there’s an effective over-the-counter remedy, pseudoephedrine, available for years. 

Pseudoephedrine, unlike phenylephrine, provides genuine relief from stuffy noses by constricting blood vessels that swell during colds, flu, or allergies.

However, purchasing products containing pseudoephedrine comes with specific regulations due to its potential use in manufacturing illegal substances like methamphetamine. It’s essential to understand these regulations:

  1. Dosing: Follow the recommended dosages on the label, and discontinue use if you experience dizziness, nervousness, or sleeplessness.
  1. Medical Conditions: Consumers with heart disease, high blood pressure, thyroid issues, diabetes, or an enlarged prostate should consult a healthcare provider, such as a pharmacist or physician, before using products with pseudoephedrine.
  1. Interactions: Avoid using products with pseudoephedrine while taking, or within two weeks of stopping, prescription monoamine oxidase inhibitors (commonly used for depression or Parkinson’s disease).

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Source: The Conversation

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