An advisory committee of the Federal Drug Administration (FDA) concluded in September that a common decongestant ingredient, phenylephrine, which is used in more than 250 over-the-counter medications, is ineffective. With cold season underway, COVID-19 cases rising and influenza likely to peak in the winter, what’s the best way to navigate this new development? We spoke with Dr. Ravi Kavasery, Blue Shield of California’s deputy chief medical officer, to see if you need to clean out your medicine cabinet and to help you find other ways to relieve nasal congestion.
First of all, what is phenylephrine?
Phenylephrine is a common ingredient in a variety of cold and flu treatments, such as nasal sprays, oral tablets and cough syrup. It’s found in popular brand-name products such as Nyquil, Theraflu and Robitussin, and a whole host of generic offerings at pharmacies and grocery stores. Chemically speaking, phenylephrine works by temporarily constricting blood vessels. You will see it in common medications formulated as a salt, such as pseudoephedrine hydrochloride, typically abbreviated to “pseudoephedrine HCl” on the label.
What did the FDA committee find wrong with it?
The FDA panel reviewed several existing studies, concluding that the drug at its existing dosages — often 10 mg — was no better than a placebo. In short, phenylephrine gets attacked by enzymes in the stomach, rendering it ineffective. It never gets to the nose. The report noted that an effective dosing level for phenylephrine has not been established, but clinical data shows levels of 80 to 90 mg would result in rises in blood pressure. Half that dose, 40 mg, which would be considered safe, was found to be ineffective. (If you want to see the comprehensive review on the topic, the full document can be found here.)
Should I throw out medications that contain phenylephrine?
Not necessarily. First of all, phenylephrine has not been declared dangerous, just ineffective. The FDA will likely ban its use in the near future, but the agency might give companies some time to phase it out. If you have to restock your supply of nasal decongestant anyway, you should consider other options. Just know that if you do continue to take a cold medication with phenylephrine, the ingredient won’t relieve your nasal congestion.
So what are some alternatives to phenylephrine?
Alternate solutions include:
- Nasal irrigation. Neti pots involve running a saline solution through your nasal passages to rinse out debris or mucus. It can help relieve symptoms of congestion and be good for sinus health, but it’s important to use good hygiene. Use distilled or sterile water. You can sterilize tap water by boiling it for five minutes then letting it cool to a lukewarm temperature. Use the recommended ratio of salt to water, which can be bought already in premixed packets of sodium chloride (salt) and sodium bicarbonate (baking soda). You can find more on Neti pots here.
- Vaporizers and humidifiers. Both devices work to add moisture to the air in a room. They can help reduce stuffiness, loosen mucus and alleviate a cough. Be mindful of keeping them clean.
- Nasal sprays. Nasal steroids, such as Flonase, and nasal antihistamines, such as azelastine, are another solution. There’s also oxymetazoline (brand name Afrin), which is sold over-the-counter as a 12-hour spray, but is intended to only be used for a maximum of three days. You might want to first try a simple solution: saline (salt water) nasal sprays can help moisturize and open up nasal passages.
What other advice do you have?
Keep in mind that while there are many ways to relieve nasal congestion, make sure to check with your doctor if symptoms linger. You should also talk with your physician if you want to try a new medication and have certain health conditions such as heart disease, high blood pressure or diabetes, which can be affected by medications such as pseudoephedrine, oxymetazoline and others. But overall, see what remedies work best for you.
Here’s wishing you good health during the time of year we see a spike in cases of respiratory-related illnesses.