A U.S. Food and Drug Administration (FDA) advisory committee on Tuesday unanimously agreed that common cold medicines containing the active ingredient phenylephrine do not work when it comes to relieving decongestion.
If the FDA follows the recommendations of the panel (which it often does), it could end the sales of dozens of popular products, such as Sudafed PE, Tylenol Sinus + Headache, and Vicks DayQuil Cold and Flu.
Noting that the FDA has been evaluating data with regard to the efficacy of oral phenylephrine (PE) since 2007, the 10-member Nonprescription Drug Advisory Committee (NDAC) said, “we have now come to the initial conclusion that orally administered PE is not effective as a nasal decongestant.”
Their decision was based primarily on three large recent clinical trials evaluating the effect of these medications containing phenylephrine. The advisory panel highlighted that previous studies supporting the use of such products had significant deficiencies and did not meet current quality standards.
While finding that these medications were no more effective than a placebo, the group stressed that it found no safety issues with these products.
A Potential Major Disruption for the Cold Medicine Industry
NDAC recognized that its decision could lead to a seismic shift in the pharmaceutical industry. Medicines containing phenylephrine are used by millions of Americans and generate billions of dollars in sales, according to the panel.
“We understand that a significant impact on industry would be inevitable,” wrote the committee.
In response to the decision, the Consumer Healthcare Products Association (CHPA), a trade association representing drug manufacturers, issued a statement saying that regulations for phenylephrine remain unchanged at this time, and products containing the ingredient continue to be on store shelves.
“We are disappointed by the outcome of today’s FDA Advisory Committee meeting because its non-binding recommendation is at odds with the numerous clinical trials and previous regulatory determinations affirming oral PE as a safe and effective decongestant at its labeled dose,” said CHPA president and CEO Scott Melville. “As stated in the FDA briefing document and highlighted by the committee chair, FDA has not identified any safety issues with orally administered PE. The meeting was a scientific review of recent research on PE efficacy.”
Timing for a full decision on this by the FDA is still uncertain.
No Cure for the Common Cold
Lauren Eggert, MD, a clinical assistant professor who specializes in pulmonary, allergy, and critical care medicine at Stanford Health Care in California, says that she wasn’t surprised by the decision.
“Even back when I was in training as an internal medicine resident, there has been little to no evidence that these products are really effective in treating the common cold,” says Dr. Eggert. “The best treatment is just going to be good old-fashioned supportive care. I know it's not glamorous and it's not a quick fix, but when you have a cold, you really just need rest and hydration.”
That said, she sees no harm in taking these products for patients who believe these medicines make them feel better.
“There may be a placebo effect and there is something to be said for that,” says Eggert. “The common cold is miserable. Patients sometimes tell me that they really believe things help them even if it’s not evidence-based. If it's not harmful and a patient thinks something is helping, I fully support that.”
Alternatives to Oral Phenylephrine
While there’s still no cure for the common cold, other products are still considered effective at relieving cold symptoms. These include nasal sprays that contain phenylephrine. (It’s just the oral version that’s in question.) Health authorities say drugs containing an antihistamine and pseudoephedrine may also be effective.
The FDA panel cautioned, however, that pseudoephedrine is now regulated as a “behind-the-counter” product and can only be bought from pharmacies in limited quantities because of concerns that it can be used to make crystal methamphetamine.
Sarah Lynch, PharmD, a clinical assistant professor of pharmacy practice at Binghamton University at the State University of New York, further added that consumers may be confused by which products contain phenylephrine.
“Consumers will often recognize a product by its most common brand name, like Sudafed or Benadryl or Nyquil, but these 'brand name extensions' will often manufacture products with other ingredients or combinations. Some of them may include phenylephrine, but many of them will not,” said Dr. Lynch in a statement. “Your pharmacist is a great resource if you have questions about any over-the-counter products you are using. Pharmacists can also make recommendations for alternative products that may help your symptoms as well.”
