As FDA Considers Pulling Phenylephrine, Doctors Consider Patient Alternatives

After a U.S. Food and Drug Administration (FDA) panel this week advised against phenylephrine as an effective decongestant when taken orally, doctors are reconsidering what to prescribe patients for a stuffy nose.

The FDA advisory panel said oral forms of phenylephrine – a nasal decongestant commonly found in over-the-counter drugs like Nyquil, Benadryl, Sudafed and Mucinex – don’t work. 

The panel said the ingredient does not absorb into the body as previously thought and is no more effective than a placebo when taken in pill form.

Dr. James Clark, an allergy and immunology specialist with Charleston Area Medical Center, said while they take longer to work, over the counter steroid nasal sprays are a safe and effective alternative. However, they require patience on the part of the patient.

“One of the best ways to alleviate nasal congestion is the regular use of a steroid nasal spray, and those are all over the counter now,” Clark said. “The problem is those medicines don’t work right away, you have to use them regularly for a few days minimum before you start to see improvement.”

Examples of steroid nasal sprays include Flonase, Rhinocort, Nasonex and Nasacort. They work by helping to minimize allergy symptoms like sinus congestion, sneezing, itchy or runny nose and itchy/watery eyes.

Clark said most medicines for allergies use a combination of antihistamines and decongestants to make them more effective. He said while topical non-steroid decongestants work rapidly, they need consideration because of their rebound effect and propensity for addiction. 

Rebound congestion is caused by using nasal decongestant sprays for more than three days in a row. The blood vessels in nasal passageways can become sensitized to the active ingredients and react by swelling as the medication wears off.

Non-steroid decongestants include Naphazoline, which works by temporarily narrowing the blood vessels, and Oxymetazoline, which is sold under the brand name Afrin, works the same way. It is used for nasal congestion, allergic reactions of the eye, and facial erythema associated with rosacea. 

Clark said oral decongestants like Sudafed that contain pseudoephedrine work well, but have purchase restrictions. In 2006, over-the-counter medications containing pseudoephedrine were moved behind the pharmacy counter because of concerns they could be used to make illicit methamphetamines. Sudafed PE which contains phenylephrine is readily available over the counter. 

Clark said he is not a big fan of decongestants in general because of the way they work.

“Number one, they shrink down the caliber of a blood vessel,” Clark said. “What causes congestion is blood vessels being swollen. And when you shrink down the caliber of a blood vessel you increase the pressure in there so decongestants like Sudafed have the potential to increase blood pressure, which isn’t good in older people, and also in males it can cause problems with the prostate.”

Last year sales of products containing phenylephrine totaled nearly $1.8 billion.

If the FDA takes the panel’s advice and pulls phenylephrine from the market, manufacturers would be required to remove all products containing the ingredient from store shelves.

Manufacturers like Procter & Gamble and Johnson & Johnson, as well as pharmacy chains, which sell over-the-counter cold and allergy pills would be affected.

The same panel of researchers that advised the FDA about phenylephrine, questioned the drug’s effectiveness in 2007. 

The FDA allowed the products to remain on the market pending additional research.