By Barbara Pierce
The leading decongestant used by millions of Americans looking for relief from a stuffy nose is likely no better than a dummy pill, according to new research by the FDA.
Advisers to the FDA voted unanimously (in mid-September, 2023) against the effectiveness of the ingredient that is found in popular versions of Sudafed, Dayquil and other medications sold in pharmacies. That ingredient is phenylephrine. Phenylephrine is in a class of medications called nasal decongestants.
Walk down the cold and flu aisle in any drugstore and you’ll spot dozens of over-the-counter drugs that contain phenylephrine — Sudafed PE, Dayquil, Nyquil, Mucinex, Tylenol, Benadryl, Vicks Cold and Flu Relief among them. Yes, they’re all duds.
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” said one of the ex-perts online. Recent large, rigorously conducted studies showed the products with phenylephrine failed to outperform placebo pills in patients with cold and allergy congestion.
The over-the-counter products with phenylephrine were approved in 1976 when studies showed they were effective for nasal congestion. Advisers found numerous flaws with those original studies used to support phenylephrine’s approval. The studies were “extremely small” and used statistical and research techniques no longer accepted by the agency, advisers said.
The latest research shows that phenylephrine in pill form is quickly metabolized, leaving only trace levels to relieve congestion. However, nasal sprays that contain phenylephrine are still effective, the FDA said.
Now it’s up to the FDA to decide whether to ban over-the-counter use of widely used cold and flu decongestants which contain phenylephrine. Products that include the ingredient — roughly 250 of them — generated approximately $1.8 billion in sales in 2022, the FDA said.
Now that these popular products have been deemed ineffective, we wondered what is effective for a stuffy nose? We asked Deirdre Pierce, pharmacist for quality improvement at Excellus BlueCross BlueShield.
“Nasal sprays containing the generic product oxymetazoline (also available under brand names Afrin®, Sinex®, and many others) work well within minutes and last 12 hours,” she advised. “You spray the medication right where it is needed in the nasal passages. This avoids possible side effects that can happen with decongestants taken by mouth, like a racing heart, trouble sleeping, or nervousness. Be sure to always follow the label instructions.”
“Saline nasal sprays are medication-free but can help moisten and thin out mucus in the nose, which can reduce stuffiness,” she added. “Use them as often as needed.”
“Another option for cold or flu is decongestant tablets containing the generic product pseudoephedrine,” she said.
That’s pseudoephedrine, which is a different ingredient than the one recently banned. It’s known by the brand name Sudafed, the original Sudafed.
“There are also products made with combinations of pseudoephedrine with other cold relief medications for cough and fever,” she continued. “Various products have differing information for use, so check the label for instructions.”
“If you need help choosing the best product, your pharmacist can help you.”
Products containing pseudoephedrine are carried behind the pharmacy counter and you must request them; a 2006 law forced this move because pseudoephedrine can be illegally processed into methamphetamine, which is highly addictive.
“For children with a stuffy nose or symptoms of cold or flu, check with your child’s doctor for the best treatment choice,” she said. “Children younger than 6 should not use over-the-counter medications,” according to John Hopkins Hospital, online.
To help relieve the misery of colds, in addition to taking a pill, consider these suggestions from John Hopkins:
Stay hydrated: Whether it’s tea, warm water with lemon or broth, drinking warm liquids can be soothing, prevent dehydration and ease congestion. Avoid salty foods, alcohol, coffee and sugary drinks, which can be dehydrating. You may also consider an IV Drip Therapy to help you regain the nutrients that you lost and help your body rehydrate.
Gargle with salt water: A saltwater gargle with one teaspoon of salt per cup of warm water can help reduce the pain and swelling of a sore throat.
Humidify the air: Cold air holds less moisture than warm air. Dry nostrils are more prone to viruses and if you’re already sick, dry air can worsen a sore throat. Try using a humidifier. If you don’t have one, leave a shallow bowl of water out, particularly near a heat source. As the water evaporates, it’ll slowly humidify the room. Or take a hot shower.
Go outside: Cold can tighten the blood vessels in your nose which will give you relief.
Rest: Recharge your body’s immune system. Rest and sleep are the best ways to do that.
This is also a great chance to take a break from strenuous exercise for two to three days.
Don’t bother with zinc; there’s little evidence to support zinc’s cold-fighting reputation. Same with Vitamin C. Same with antibiotics as they’re designed to treat bacterial infections, not viruses.