The cold medicine you rely on doesn’t do what it says on the label, according to the FDA.
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.
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.
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.
- Guaifenesin as a cough medicine used to clear mucus from the airways.
- Dextromethorphan as a cough suppressant for upper respiratory infections.
FDA Panel Found Clinical Trials Were ‘Problematic’
The FDA also found problems with the clinical trials conducted by drug manufacturers that initially claimed phenylephrine’s effectiveness.
“All of the studies (both positive and negative) were highly problematic in both design and methodology,” the reviewers wrote. “All used a highly variable endpoint (NAR) to study a drug in the setting of a highly variable disease state (the common cold) that is no longer used as a primary endpoint to evaluate congestion in pivotal trials.”
The reviewers said the multiple statistical and methodological flaws in the studies make them “unacceptable” as continued evidence for phenylephrine’s efficacy at recommended oral doses.
Scientific Evidence Against PE Goes Back Years
Although the FDA panel’s findings are new, studies as early as 2009 found oral phenylephrine no more effective than a placebo. One study compared pseudoephedrine and phenylephrine. Only pseudoephedrine significantly improved nasal congestion over six hours.
Sometimes, the Best Medicine Is Time
With a new school year starting, the FDA panel findings are of particular interest to parents. Colder weather brings more colds and flu. It’s essential for physicians to discuss all OTC medications with families when children are sick, Dr. Sharon Nachman, chief of the Division of Pediatric Infectious Diseases at Stony Brook Children’s Hospital, told The Epoch Times.
“Some may be more effective, and some are less effective,” she said, adding that it is important not to use ineffective ones.
When children are sick, Dr. Nachman recommends parents take a common-sense approach to caring for them. That means focusing on providing fluids to prevent dehydration, giving analgesics to relieve discomfort, and allowing the illness to run its course. “Sometimes nothing can make your child heal faster except some time.”
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