Phenylephrine or placebo?

Sudafed has been a household name for decades, and the drug's active ingredient pseudoephedrine has been around since the 1920s.

Recently, the U.S. Food and Drug Administration (FDA) claimed One of Sudafed's popular products, Sudafed PE, is ineffective and should be banned from over-the-counter use. The announcement comes about a year after an FDA advisory panel unanimously stated that oral phenylephrine is not effective in relieving congestion.

The PE in Sudafed PE is derived from phenylephrine, another active ingredient sold as an orally ingested product. should Temporarily relieves nasal congestion. Many other over-the-counter (OTC) combination medications contain phenylephrine, including some products under the brand names NyQuil, Benadryl, and Mucinex.

In October 2023, CVS Pharmacy will remove common cold and cough medicines that list phenylephrine as the active ingredient from its shelves, following a decision by an FDA advisory committee.

“It is the FDA's role to ensure that medicines are safe and effective,” said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). “Based on our review of the available data and on the advice of our advisory committee, we are moving to the next step in the process proposing the removal of phenylephrine because oral phenylephrine is ineffective as a nasal obstructor.”

The FDA notes that its recommendation pertains only to orally administered phenylephrine, although phenylephrine is also included in many nasal sprays.

Enter public comment period

Jason Scheid, director of pharmacy services for community and specialty pharmacy at OSF Healthcare, said the FDA is currently seeking public comment on the proposal until May 7, 2025. A final order is expected to be issued after a 180-day comment period.

“At that point (after 180 days), FDA will give the manufacturer appropriate warning as to whether the product should be discontinued or reformulated to find a replacement that meets labeling requirements.” Scheid he says.

Scheid predicts that if drug companies reformulate these products and want to maintain their functionality as oral nasal decongestants, they will need to include pseudoephedrine in them. This will push even more product behind the pharmacy counter, much like the original Sudafed.

“If you're looking for an oral nasal decongestant, original Sudafed is a good alternative,” Scheid added. “Identification is required and there are restrictions on purchases. It has been proven to be an effective alternative. You can try nasal decongestants such as Afrin, nasal steroids and There are also antihistamines, all of which are available over-the-counter at your local pharmacy.

Phenylephrine or placebo?

The FDA has proposed banning these products from store shelves, but has made it clear that there are no safety concerns. It's just not effective. Many drugs claim to have multiple effects. For example, Mucinex Sinus-Max® claims to unclog sinuses and reduce headaches while thinning and loosening mucus. However, this drug also contains acetaminophen and guaifenesin. Scheid said the proposal only targets the phenylephrine component when considering nasal decongestion, so other effects may still be considered.

“You may have a placebo-like effect. You may just feel better because of the other ingredients in it, but that ingredient (phenylephrine) alone is not enough to keep you selling it over the counter.” It does not meet the effectiveness criteria of

Natural treatment options that can relieve symptoms

“A hot shower or a cool-mist humidifier will add moisture to the area and reduce congestion,” says Scheid. “Simple measures like saline nasal sprays can moisturize the nasal passages and relieve symptoms.”

What is always important is clean the humidifier Do this after every use to prevent mold and other bacteria from being released into the air.

Do not use too much nasal spray

Another reason it's important to read the label is the effect nasal sprays can have if used for longer than they were originally intended. Most nasal decongestant sprays recommend using the product for no more than three days.

“What happens is rebound congestion, and the medicine that relieves that pressure loses its effectiveness, and if you use it for more than a few days, it builds up even more,” Scheid says.

When traffic jams are caused by allergies

According to the Centers for Disease Control and Prevention (CDC), about a quarter (25.7%) of American adults have seasonal allergies, and nearly one in five (18.9%) children are affected. Scheid says treating nasal congestion in people with allergies is a long-term problem.

“Then you're looking at long-term solutions, either long-term nasal steroid sprays, antihistamine sprays, or oral antihistamines.”

Scheid says if the FDA's proposal passes in May, pharmacy shelves will look very different than they do today.

Another way to eliminate congestion is to to keep hydrated. Drinking water thins mucus from your nose and loosens phlegm in your lungs, making coughing easier.