FDA Admits Oral Congestion Medication Found In 250 Products Doesn’t Work

Recently an advisory panel to the U.S. Food and Drug Administration (FDA), unanimously agreed that phenylephrine does not work when taken orally. Essentially, it is no better than a placebo. What’s interesting is that the drug has been available for over 60 years and can currently be found in around 250 products.

The cold and flu industry raked in about $1.8 billion in sales last year. Products like Tylenol, Mucinex, Benadryl, (nonprescription) Sudafed, and Nyquil, to name a few. So the question is, how can a product that is ineffective be allowed to remain on store shelves for so long?

Well longevity may be the problem. It seems that back then the testing procedures were not that rigorous, and when they were toughened in the 1970’s the drug was basically grandfathered in.

The finding isn’t shocking because oral usage of phenylephrine’s effectiveness has been questioned for decades. Now, the FDA has a decision to make. Do they require it to be removed from over-the-counter products or not. Doing so may “significantly disrupt the market for the makers of cold medicines” and confuse people looking for relief from cold symptoms as the fall and winter descend on the country.

The Combat Methamphetamine Act of 2005 moved pseudoephedrine, which is quite effective for the temporary relief of nasal congestion, behind the counter of U.S. pharmacies. Pseudoephedrine was being used to produce illicit methamphetamines, and the U.S. Drug Enforcement Agency (DEA) wanted to limit its access. This restriction on pseudoephedrine, however, has not decreased the use of illicit methamphetamines in the U.S.

The reason is that even though it has been moved out of sight, it isn’t out of mind and since only a driver’s license or photo ID is required and not a prescription, it is still available.

Drug companies, concerned about sales quickly reformulated their products with phenylephrine. So for example, Sudafed was moved behind the counter, but Sudafed PE can be found on store shelves.

In an interview with The Brink, a research publication from Boston University, Dr.

Michael Platt, a Boston University Chobanian & Avedisian School of Medicine associate professor of otolaryngology–head and neck surgery, spoke about what this news means for doctors and consumers.

The Brink: Was this news of phenylephrine being ineffective surprising to you?

Platt: This medication, phenylephrine, is lumped into the category of a decongestant. If you go back and look at guidelines from decades ago, there was no evidence that it worked, so this decision isn’t a surprise. I don’t think I’ve recommended this product over the past 15 years in practice. But it raises questions [of] how something like this could happen, when you look back at the history of drug approvals and how long it takes to change things that have been approved.

The Brink: If this ingredient doesn’t work, why have these products been available for so long?

Platt: Phenylephrine is effective topically as a decongestant, so as a nasal spray. And there’s not many decongestants available over the counter. We have pseudoephedrine, which works, but is now only [available] behind the counter due to the potential to be misused. We also have oxymetazoline, which is the main ingredient in Afrin. So, phenylephrine filled a need to have medicine that was more easily accessible. But if you go back and look at the data, studies about this drug were all industry-sponsored studies, which always have some inherent bias in them. Clearly the data was not strong.

The Brink: So, I’m assuming the topical products won’t be affected?

Platt: That’s correct. Topical decongestants are really only appropriate for short-term use. If you use them long-term, you get worse problems. Many people get addicted to them, and they don’t treat the underlying disease process. For chronic disorders, including nasal allergies, seasonal allergies, I don’t recommend decongestants for those patients. There are better medications, like antihistamines, which are available both topically and systemically. There’s nasal steroid sprays that work really well and are safe.

The Brink: So, you’re not worried about a shortage of products if some have to come off the shelves?

Platt: No, there are much better options. I think it’ll be a good thing if oral phenylephrine products come off the shelf since they don’t work and have side effects that could cause harm. Steering patients toward safer, better alternatives would definitely be a win for everyone. Patients can easily get into the habit of putting a band-aid on the problem—they have congestion, therefore think they need a decongestant. The next thing you know, they’re using it chronically when they shouldn’t be. Congestion is a very generic symptom, and it can be due to diseases that are sometimes not serious, but there are also serious diseases that occur in the nose that can present with congestion. It’s important to understand what you’re actually treating.

The Brink: How do decongestants work?

Platt: They stimulate the autonomic nervous system to give you a response similar to adrenaline or epinephrine, which constricts blood vessels. So, in your nose, you’re shrinking the blood vessels and decreasing the blood supply into the nose. Structures in the nose, called turbinates’ swell up when you get a cold or allergies. They’re like round balls of tissue in your nose, and they fill up with blood and get swollen, and when you take a decongestant, it shrinks those blood vessels. It also makes your blood pressure go up, just like adrenaline does.

The Brink: What would your general advice be for people searching for an effective over-the-counter product for a cold?

Platt: If it’s a short-term need for a decongestant, I prefer topical decongestants that you spray in your nose, and topical antihistamine sprays that don’t have those same side effects on blood pressure and are accessible. It’s important to know what you’re treating, and primary care doctors can make diagnoses, and when they can’t, they send patients to rhinologists like me or allergists/immunologists. We all often work together to get the right diagnosis, and then the best treatment plan.

The Brink: What do you think will happen now that it’s up to the FDA?

Platt: I can’t see how the FDA would ignore this type of recommendation and ignore the data. The FDA follows the science and I don’t see how they’re not going to remove these products. I think patients will seek better alternatives that are more effective and safer.

It’s enlightening to know that products the American public has been using to help cold congestion for decades has had little to no effect. At least now armed with this information we can all make wiser decisions going forward.

Happy Fall!