Cold Medicines May Face Shortages if Popular Decongestant Is Pulled

Recent studies find oral decongestant phenylephrine ineffective, posing dilemma for FDA. Reform may be needed in the OTC drug approval process.

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That bottle of extra-strength cold medicine from the drugstore shelf does not actually relieve stuffy nose, but removing it may cause more problems than it’s worth.

Phenylephrine, the popular decongestant found in many over-the-counter (OTC) remedies, including Dayquil, was deemed ineffective by the U.S. Food and Drug Administration (FDA) last year. Yet it remains in circulation, leaving some experts concerned that a potential removal could trigger shortages of cough syrups and other drug supply chain disruptions.

Long Road Ahead to Remove Phenylephrine

Existing data don’t support the effectiveness of phenylephrine as an oral decongestant, according to a September 2023 FDA advisory committee announcement. The agency is now requesting public comments as it weighs removing phenylephrine-containing medicines from shelves.

If the FDA ultimately deems oral phenylephrine ineffective, it would declare the drug no longer safe and effective. The agency would then work with drugmakers to reformulate cold and allergy medicines containing phenylephrine.

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Phenylephrine was grandfathered into the OTC approval process, making it difficult to remove despite improved science, Nazlie Latefi, who holds a doctorate in neuroscience, biochemistry, and molecular biology and is the co-founder and chief scientific officer at Applied Biological Laboratories Inc., told The Epoch Times.

“It took almost 20 years and two petitions to the FDA by experts to have phenylephrine deemed ineffective,” she added.

However, research shows phenylephrine remains the top decongestant choice for consumers, though doubts about its effectiveness date back to the 1990s. It’s also widely combined with other OTC drugs. This means removing phenylephrine could severely affect the availability of multisymptom cold and allergy products until reformulated to meet FDA requirements.

Most Cold Medicines With Phenylephrine Could Vanish

A recent research letter in the Journal of the American Medical Association explored potential drug supply chain disruptions if the FDA removes oral phenylephrine.

Analyzing purchasing data from 2012 to 2021, researchers found U.S. pharmacies acquired 19.8 billion units of phenylephrine products—far more than the 13.2 billion units of pseudoephedrine, the only other OTC decongestant.

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Additionally, 85.5 percent of phenylephrine products—typically pain relievers and cough suppressants—contained multiple active ingredients versus just 15.8 percent of pseudoephedrine products with other active ingredients.

Should the FDA follow the advisory panel’s recommendation to remove oral phenylephrine, most multisymptom cold medicines containing it would also vanish from shelves, according to the letter. With limited pseudoephedrine alternatives, this could create drug shortages.

A reform is needed in the OTC drug review process, Dr. Timothy Anderson, the lead author, said in a press statement. This includes holding OTC medications to the same efficacy standards as prescription medications and better monitoring their risks and benefits post-approval.

Oral Pseudoephedrine Is Safe and Still Available

How did an oral decongestant with no evidence of effectiveness replace a long-standing, safe, and effective drug like pseudoephedrine? The reason dates back to the methamphetamine epidemic of the 1990s.

Pseudoephedrine was restricted in the 2000s due to its use for making methamphetamine. The Combat Methamphetamine Epidemic Act of 2005 strictly limited OTC sales. Pseudoephedrine soon vanished from cold medicine shelves, replaced by phenylephrine.

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The meth-related restrictions proved ineffective, though, as foreign cartels now use alternate manufacturing methods. Pseudoephedrine itself was never unsafe nor ineffective—just highly inconvenient to obtain. This paved the way for unproven phenylephrine to dominate multisymptom cold formulations.

Pseudoephedrine is generally a safe medication that can be used in the short-term by all “relatively healthy” patients, Dr. Thomas Gut, associate chair of medicine at Staten Island University Hospital in New York, told The Epoch Times. Patients who shouldn’t use the drug include those with uncontrolled blood pressure, significant prostate enlargement, poorly managed diabetes, untreated hyperthyroidism, or certain types of glaucoma, he added.

While it may be easy to grab an OTC medication off the pharmacy shelf, consulting a primary care doctor to discuss the safest and most effective options is wisest, he added.