Colds, flu, or allergies can send you running to the medicine aisle looking for nasal decongestants that claim to relieve symptoms and unblock a stuffy nose.
But the active ingredient in many of them, called phenylephrine (PE), doesn’t offer any real benefits when taken orally, according to the U.S. Food and Drug Administration (FDA). In fact, it may even cause harm, according to Dr. William Schaffner, an infectious disease specialist and professor at Vanderbilt University School of Medicine.
“I would hope that [the drugs] would be withdrawn because there’s no point in taking ineffective medication,” he told The Epoch Times, noting that phenylephrine is a medication that can increase heart rate and cause problems for some people.
Why Use Phenylephrine?
It began with the fight against methamphetamine trafficking. Since pseudoephedrine can be used in the illicit manufacture of this drug, the FDA responded with the Combat Methamphetamine Epidemic Act, which became law in 2006. It banned the OTC sale of medicines containing pseudoephedrine, ephedrine, and phenylpropanolamine. Customers now must request these medications from pharmacy staff.
This left OTC drugs containing phenylephrine as the only easily accessible option.
While the drug’s safety remains unquestioned, the FDA investigated phenylephrine’s efficacy and determined it simply doesn’t work.
This week, the FDA released a briefing (pdf) of its investigation as background for an advisory committee meeting that will decide whether to revoke oral phenylephrine’s “generally recognized as safe and effective” (GRASE) designation due to lack of efficacy.
The briefing noted there is a reasonable expectation that, when used as directed, the drug should provide clinically significant symptom relief. However, reviewers found oral phenylephrine is not an effective nasal decongestant at either the recommended 10-milligram dose every four hours or at higher 40-milligram doses. An effective oral dose of PE for nasal decongestion is unknown.
Phenylephrine is not the only ineffective OTC medication. Others include:
- Guaifenesin as a cough medicine used to clear mucus from the airways.
- Dextromethorphan as a cough suppressant for upper respiratory infections.
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