The U.S. healthcare system is confusing and mangled as it is, and panic around the global coronavirus pandemic hasn't quite helped to improve the public's trust in authoritative voices.
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Fortunately, as the U.S. emerges from the covid disaster and people once again feel safe to travel, participate in concerts, and dine out, the sentiment that we'll be okay as a society is more vital than ever. A lot of that trust is up to the individual, who may decide to continue masking on airplanes and practicing social distancing at high-density events.
But in truth, some of that trust is also up to government agencies, particularly the U.S.-based Food and Drug Administration (FDA), which from time to time must make judgement calls on the efficacy of certain drugs or practices and their safety for the public.
Some medicines in jeopardy following FDA advisory finding
New covid boosters may be grabbing headlines, but a recent finding about other medicines might just affect consumers more –particularly if they happen to contract a new strain of the coronavirus, flu, or cold this winter.
According to an FDA briefing document entitled, "Efficacy of Oral Phenylephrine as a Nasal Decongestant," several cold and flu medicines contain an ingredient called phenylephrine, which a panel argues is ineffective against common symptoms like congestion and stuffy nose.
"We believe that these new clinical pharmacology and clinical data are consistent, substantial, and believable, and they confirm that orally administered PE is not effective at any dose that can be developed and still provide a reasonable margin of safety," the 16 advisors found.
The panel unanimously agreed in a vote that the ingredient is ineffective and that the FDA should thus examine medicines that contain it and act accordingly -- potentially taking them off the shelves.
Here's a list of some of the medicines that contain phenylephrine:
- Advil Sinus Congestion & Pain
- DayQuil Cold & Flu
- NyQuil Cold & Flu
- Flonase Headache & Allergy Relief
- Benadryl Allergy Plus Congestion for Sinus Pressure & Nasal Congestion Relief
- Robitussin Nighttime Severe Multi-Symptom Cough, Cold + Flu Syrup
- Sudafed PE Sinus Congestion
- Theraflu Daytime Severe Cold Relief Berry Burst Flavor Hot Liquid Powder
- Tylenol Sinus + Headache Non-Drowsy Daytime Caplets for Nasal Congestion, Sinus Pressure & Pain Relief
Some of the manufacturers that may be affected by a decision to pull the products from shelves include Johnson & Johnson's (JNJ) -) spin-off Kenvue and Procter & Gamble (PG) -).
Retail pharmacies might also be affected by the decision, including Walgreens (WBA) -) and CVS (CVS) -). In 2022, revenue from products with phenylephrine brought in about $1.8 billion for U.S. drugstores.
The FDA can decide not to pull the items from shelves, however this is incredibly rare in a unanimous panel decision.
Phenylephrine has been around for nearly a century, but due to its age, it did not have to undergo stringent testing and trials by newer government regulatory agencies. Pharmacists, doctors, and researchers have been lobbying the FDA to pull the product for years. In 2007, similar efficacy concerns were raised but ultimately shot down following an FDA review of data and arguments by the actual drugmakers.
"We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE's regulatory status," Consumer Healthcare Products Association president Scott Melville said after the panel's findings were released on Thursday.
CHPA represents the drugmakers that produce over-the-counter drugs and other products.
"We look forward to working with FDA in the coming days to further discuss how to best move forward in the interest of patients and consumers," he added.
It's worth noting that the FDA has not issued any additional warnings about the safety surrounding phenylephrine.
