- The ramp-up to cold and flu season is a bad time for consumers to learn that some of their most trusted go-to products don’t actually work.
- The 2023 FDA advisory panel met to review growing evidence that oral phenylephrine is an ineffective treatment for nasal congestion.
- Consumers may also question whether combination cough, cold and flu products will still be safe and effective for use at home.
The backstory
- The most recent analysis is not the first time an FDA advisory panel has scrutinized oral phenylephrine.
- A 2007 panel examining its use concluded that more studies were needed to make a final decision regarding the effectiveness of phenylephrine.
Safety concerns
- No safety issues with oral phenylephrine alone were documented in the 2023 advisory panel conclusion.
- However, researchers and advisory panel members have raised concerns about the possibility of products containing ineffective phenylephrine remaining on pharmacy shelves.
- Even if oral phenylephrine is safe, taking an ineffective medication could cause consumers to spend money on products that work no better than a placebo.
The story behind pseudoephedrine
- Luckily, the nonprescription oral nasal decongestant pseudoephedrine – which is known to be effective – has been commercially available for many years.
- Pseudoephedrine is a nasal decongestant that is taken by mouth to relieve a stuffy nose.
- If the FDA acts on the advisory committee’s conclusions that oral phenylephrine is not an effective nasal decongestant, pseudoephedrine may be the only remaining oral medication available without a prescription to treat nasal congestion.
Pseudoephedrine should not be used in doses higher than those that are recommended on the label. Use of products containing pseudoephedrine should be stopped and a health care provider consulted if dizziness, nervousness or sleeplessness occurs.
Pseudoephedrine should not be used by consumers with heart disease, high blood pressure, thyroid disease, diabetes or an enlarged prostate without talking with a health care provider like a pharmacist or a physician.
Products with pseudoephedrine should not be used while taking, or within two weeks of stopping, a prescription monoamine oxidase inhibitor, which is most commonly used to treat for depression or Parkinson’s disease.
Other treatments
- These products are sold under the brand name Afrin and others.
- All of these non-drug approaches can help sooth the nasal passage to provide temporary relief from congestion.
- If symptoms of congestion continue for more than two weeks, or if signs of an infection arise, go see your doctor.
Lucas Berenbrok is part owner of the consulting company, Embarx, LLC. Colleen Culley and Karen Steinmetz Pater do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.
