- A Food and Drug Administration panel said phenylephrine, a commonly used decongestant, doesn't work.
- Phenylephrine is found in dozens of over-the-counter cold medications to relieve sinus congestion.
A decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, say government experts who reviewed the latest research on the long-questioned drug ingredient.
Advisers to the Food and Drug Administration voted unanimously on Tuesday against the effectiveness of the ingredient found in popular versions of Sudafed, Allegra, Dayquil, and other medications sold on pharmacy shelves.
"Modern studies, when well-conducted, are not showing any improvement in congestion with phenylephrine," said Dr. Mark Dykewicz, an allergy specialist at the Saint Louis University School of Medicine.
The FDA assembled its outside advisers to take another look at phenylephrine, which became the main drug in over-the-counter decongestants when medicines with an older ingredient — pseudoephedrine — were moved behind pharmacy counters. A 2006 law forced the move because pseudoephedrine can be illegally processed into methamphetamine.
Those original versions of Sudafed and other medicines remain available without a prescription, but they account for about one-fifth of the $2.2 billion market for oral decongestants. Phenylephrine versions — sometimes labeled "PE" on the packaging — make up the rest.
If the FDA follows through on the panel's recommendations, Johnson & Johnson, Bayer, and other drugmakers could be required to pull their oral medications containing phenylephrine from store shelves. That would likely force consumers to switch to the behind-the-counter versions of the pills or to nasal sprays and drops that contain phenylephrine, which are not under review.
Several other commonly purchased cold and congestion relief medications also contain phenylephrine, according to The Wall Street Journal. These medications include:
- Advil for Sinus Congestion and Pain
- Benadryl Allergy Plus Congestion for Sinus Pressure and Nasal Congestion Relief
- DayQuil for Cold and Flu
- Flonase Headache and Allergy Relief
- Mucinex Maximum Strength Sinus-Max Pressure, Pain, and Cough Liquid Gels
- NyQuil Cold & Flu
- 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
With cold and flu season on the horizon, you may need to either stock up ahead of time or find an alternative product if you use any of the medications listed above — that is, if they even work.
This week's two-day FDA committee meeting was prompted by researchers at the University of Florida, who petitioned the FDA to remove phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also challenged the drug's effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.
That was also the recommendation of FDA's outside experts at the time, who met for a similar meeting on the drug in 2007. This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn't show a benefit for the drug.
"I feel this drug in this oral dose should have been removed from the market a long time ago," said Jennifer Schwartzott, the patient representative on the panel. "Patients require and deserve medications that treat their symptoms safely and effectively and I don't believe that this medication does that."
The advisers essentially backed the conclusions of an FDA scientific review published ahead of this week's meeting, which found numerous flaws with the 1960s and 1970s studies originally used to support phenylephrine's approval. The studies were "extremely small" and used statistical and research techniques no longer accepted by the agency, regulators said.
A trade group representing nonprescription drugmakers, the Consumer Healthcare Products Association, argued that the new studies had limitations and that consumers should continue to have "easy access" to phenylephrine.
Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into use during a sweeping FDA review begun in 1972. It has been sold in various forms for more than 75 years, predating the agency's own regulations on drug effectiveness.
There's unlikely to be any immediate impact from Tuesday's panel vote, which is not binding. And the process for changing the rules has traditionally taken years or decades, requiring multiple rounds of review and public comment.
Still, a 2020 law passed by Congress streamlines the process, which could allow the FDA to accelerate the publication of new standards, doses, and labeling for nonprescription ingredients.
Are you upset about the FDA panel's decision? Are you a fan of any of the cold medicines that could be taken off of shelves? What will you do in response? Let us know by sending an email to this reporter at: htenore@insider.com.