Clogged nose woes: Doctors weigh in on decongestant medicine declared ineffective

The over-the-counter decongestant medicine you reach for when suffering from a stuffy nose or clogged sinuses may not actually be giving you much relief, according to the Food and Drug Administration.

But effective medications remain, though it may take an extra step to acquire them.

FDA advisers voted this week that a key drug found in popular versions of over-the counter decongestant medications, a component called phenylephrine, is not effective in relieving congestion.

Phenylephrine is used in versions of over-the-counter medicines that are labeled with a “-PE” at the end, like Sudafed PE or Dayquil PE.

A different type of decongestant, known as pseudoephedrine, is in versions of similar medicines that end in -D, like Mucinex-D or Claritin-D, and in regular Sudafed.

Pseudoephedrine is available with a behind-the-counter restriction, often requiring customers to talk to a pharmacist and limiting how much they can buy. It’s possible to use pseudoephedrine to create illegal drugs such as methamphetamines. Products with phenylephrine are available without talking to a pharmacist.

While PE products are not effective in reducing congestion, they may contain other ingredients that can still be effective in easing other cold or allergy symptoms. They are still safe to take without fear of harm. The FDA has not yet made a decision on whether to pull the products from the shelves.

A doubted medicine

The news that PE products are not effective was not a huge surprise to some doctors. Studies questioned the ingredient’s effectiveness as far back as 2007.

“Even close to 15 or 20 years ago, it was thought to be ineffective, but at that time they didn’t pull it,” said Dr. Bob Gorby of Westmoreland Allergy and Asthma Associates. “It’s in so many things still. … If it doesn’t work, why even keep it in these medicines?”

“I think a lot of us in the primary care setting where I work don’t necessarily recommend phenylephrine anyway. I think we’ve known for quite some time that the efficacy of how well it works to reduce nasal decongestion just hasn’t been there,” said Dr. Gregory Castelli, a UPMC clinical pharmacist with the department of family medicine.

“Whenever patients would come in, I would always kind of steer them away from the phenylephrine,” he said. “But that’s not to say that it is not one of the most utilized medications for decongestion out there, because it’s so readily available.”

More recent studies have higher levels of scrutiny and more accurate ways to measure the drug’s effectiveness, he noted. Dr. Thomas Mertz of Allergy and Asthma Associates of Pittsburgh agreed.

“The FDA has finally been able to evaluate good studies to have good data to make a decision. The best decisions with medication are with data,” Mertz said. “It’s a little different with prescription — that goes through a much more rigorous evaluation. If it’s something that is over the counter, it just goes by different rules, and it’s just not as governed as tightly as prescription.”

Dr. Shelly McQuone, an ear, nose and throat doctor at AHN who is chief of otolaryngology at the health system, noted that while the PE products are not dangerous, they also aren’t doing what they are advertised to do — clearing sinuses and noses of congestion.

“It’s not an issue of ‘are they safe’ — there’s not any kind of safety thing going on here. It’s more about efficacy,” she said. “Do they work, are they helpful, are they adding value? The FDA has concluded that they are not — they are not having any greater chance of helping your symptoms than a placebo, taking a medicine that is a sugar pill.”

Other options for medication

At this time, there is no word on whether the FDA will remove PE medications from the shelves. At pharmacy chain CVS, a spokesperson said in a statement that the company was still waiting to see what guidance the FDA would release.

“We have been monitoring the FDA’s position on the effectiveness of oral phenylephrine (PE) and are awaiting additional action and guidance from the agency and manufacturers in order to determine the appropriate next steps,” the spokesperson said.

A Walgreens spokesperson said similarly.

“We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps,” the spokesperson said.

In the meantime, stuffy-nose sufferers can seek out different over-the-counter medications for better results as the year moves into cold and flu season.

Along with pseudoephedrine, patients can take allergy antihistamine medications such as Zyrtec and Claritin for allergy symptoms, McQuone said, or nasal corticosteroids, which include over-the-counter nasal sprays like Nasonex and Flonase. Mertz suggested saline nasal spray also can help break up sinus blockage.

Gorby recommended the nasal corticosteroid sprays and pseudoephedrine, but noted the nasal sprays sometimes take time to work.

“The tendency is for people to use them for a few days and then say, ‘Well, this isn’t doing anything,’ and then they just stop them,” he said. “If they persist with them, they will be helpful.”

He also mentioned more powerful nasal medications like oxymetazoline and Afrin, which he noted are particularly effective, but can only be taken for short periods of time due to their potential to become addictive.

“Nothing works like those — those are the most effective decongestants out there,” he said. “But people develop tolerances quickly, and you get what’s called rebound congestion, so you can’t use them for more than three or five days.”

Julia Maruca is a Tribune-Review staff writer. You can contact Julia at jmaruca@triblive.com.

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