The latest research shows that the most popular decongestant in America doesn’t even work.
Millions of Americans use drugs containing phenylephrine when looking to find relief from a stuffy nose, but government experts say the latest research shows it’s not effective.
Phenylephrine was grandfathered into approval during a sweeping FDA review begun in 1972 and has been sold in various forms for more than 75 years. FDA reviewers said phenylephrine is metabolized quickly when taken by mouth, and only trace levels reach nasal passages.
Research found that phenylephrine appears to work better if it’s applied directly to the nose in sprays or drops. The sprays and drops are not under review, only the oral medications.
Why did the FDA announce this now?
University of Florida researchers petitioned the FDA to remove most phenylephrine products based on recent studies. They also challenged the drug’s effectiveness in 2007, but the FDA kept the products on the market while more research was completed.
An FDA scientific review found flaws in the 1960s and 1970s studies that supported phenylephrine’s original approval. The studies used research techniques no longer supported by the FDA.
Three larger studies published since 2016 showed no difference between phenylephrine and placebos for treating congestion. Sixteen members of an FDA panel agreed that evidence doesn’t show any benefit to phenylephrine. The group also said that studying higher doses of phenylephrine was not an option because it can raise blood pressure to potentially dangerous levels.
Which medications have phenylephrine?
Phenylephrine is found in many cold and flu medications. That includes Sudafed PE, Benadryl Allergy D Plus Sinus, and Vicks DayQuil Cold and Flu Relief. Sometimes the front of the packaging has “PE” written on it. You can look at the ingredients list on your medication to check.
Why did it get so popular?
In 2006, a law forced pseudoephedrine to move behind the counter because it can be used to make methamphetamine. That’s when phenylephrine became the main drug in over-the-counter decongestants. Original versions of Sudafed and other medications are still available without a prescription, but they’re less popular.
Will medicines that use phenylephrine be pulled from stores?
If the FDA follows through on the panel’s recommendations, drugmakers might be required to pull oral medications containing phenylephrine from store shelves. People would need to switch to behind-the-counter pseudoephedrine products or to phenylephrine-based nasal sprays and drops.
The FDA could pull phenylephrine from a federal list of decongestants deemed effective for over-the-counter pills and liquids. The FDA said removing the products would eliminate “unnecessary costs and delay in care of taking a drug that has no benefit.”
---> Read more: Popular nasal decongestant doesn’t actually relieve congestion, FDA advisers say
