PBS News Hour | Why the FDA Wants to Pull This Cold Medicine Ingredient | Season 2024 | Montana PBS

WILLIAM BRANGHAM: In the winter in much of the country, we also prepare for cold and cough season, when people often turn to over-the-counter medications.

But the FDA now says a common long-used ingredient in many of these drugs is ineffective and should be removed.

As Stephanie Sy tells us, this decision proposal could come into force as soon as next year.

STEPHANIE SY: Phenylephrine is an ingredient in versions of popular cold medicines, including NyQuil, Benadryl and Sudafed.

The FDA is proposing to take it off the shelves, not because it’s dangerous, but because it doesn’t work, at least when taken as a pill or syrup.

It can be effective when given in a nasal spray.

Dr. Randy Hatton helps us understand why the FDA is taking this action.

He is a professor at the University of Florida College of Pharmacy who has been raising awareness of this issue for two decades.

Dr. Hatton, thank you very much for joining the “News Hour.”

I know you and another researcher have been thinking about this for years.

I have to ask, why has phenylephrine become so common in cold and flu remedies if it doesn’t help, and why have we all been buying it for so long?

RANDY HATTON, University of Florida College of Pharmacy: Yes, you’re right.

Dr. Leslie Hendeles and I have been working on this for 20 years, when we became aware of the problems with oral phenylephrine after pseudoephedrine was moved behind the counter because of fears about how it could be used to make methamphetamine in clandestine labs.

So when pseudoephedrine was moved behind the counter, pseudoephedrine was replaced by phenylephrine and was widely used.

And then patients began to complain about its ineffectiveness.

STEPHANIE SY: This ingredient has been declared safe by the FDA.

So why do you think it’s important to get it off the shelves?

RANDY HATTON: Yes, it’s safe because basically it doesn’t absorb.

It is absorbed in less than 1 percent of the administered dose.

And that’s why it doesn’t work.

So why should it be removed?

Because it doesn’t work.

Medicines on the market in the United States must be both safe and effective, whether over-the-counter or prescription.

And oral phenylephrine is ineffective.

STEPHANIE SY: What is an option for people who are suffering from colds, especially this time of year?

Is it a medicine with a higher dose of this product?

Going back to the pseudoephedrine that you mentioned but is hard for a lot of people to get off of?

Or does it use a nasal spray version of this?

RANDY HATTON: First of all, I would never recommend a higher than stated dosage for oral phenylephrine products.

Many of these products are combination products.

And some drugs like Tylenol or acetaminophen that are in these products can be toxic in high doses.

So definitely don’t take more than the indicated amount.

The only effective oral decongestant that would help with nasal congestion is over the counter.

And it’s considered a barrier, but frankly, if you go to a pharmacy, you can get that pseudoephedrine behind the counter in most cases in less than five minutes.

I think if someone can tolerate using the nasal sprays, the sprays are very effective and can be used briefly, three to five days, at the worst of a cold, maybe to help someone sleep at night.

One is called – the brand names are Afrin or Sinex 12 Hour, which contains the active ingredient oxymetazoline.

Or phenylephrine, which is ineffective by mouth if it’s in a nasal spray, is effective when injected into the nostrils.

STEPHANIE SY: OK. And to be clear, you can get pseudoephedrine over the counter, but you don’t need a prescription.

All you have to do is ask the pharmacist, right?

I have to ask you this.

Can’t we all buy other drugs at the pharmacy that don’t work as advertised?

And are you saying that the FDA should also take all those drugs off the shelves?

RANDY HATTON: Yes, I think there are some old over the counter products that deserve a facelift.

Just as the FDA reviewed oral phenylephrine, some of the older products approved by science decades ago are likely to be ineffective.

But to prove this belief we need proper science to look at these products and decide if we should be spending our hard earned money on ineffective products.

STEPHANIE SY: Dr. Hatton, critics of this move by the FDA say it limits consumer choices.

What do you say to that?

RANDY HATTON: So it would limit the choice to something that doesn’t work.

Why would anyone want to choose something that doesn’t work?

And like I said, a drug has to be effective to be approved by the FDA.

We wouldn’t want to choose among ineffective products.

It’s not a choice.

The alternative would be to choose from effective and safe products that the FDA has reviewed and said are suitable for the indications we want to use them for.

STEPHANIE SY: Dr. Randy Hatton, thank you so much for sharing your perspective on this with us.

RANDY HATTON: I’m glad.

Thanks for the invitation.