Why the FDA wants to pull this common cold medicine ingredient from shelves

William Brangham:

With winter setting in around much of the country, we are also gearing up for cold and cough season, when people frequently reach for over-the-counter medicines.

But the FDA now says that a common long-used ingredient in many of those medicines is ineffective and it should be removed.

As Stephanie Sy tells us, this proposed ruling could go into effect 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 taking it off shelves not because it's unsafe, but because it doesn't work, at least not when it's taken as a pill or syrup. It can be effective when administered in a nasal spray.

To help us understand why the FDA is making this move, we're joined by Dr. Randy Hatton. He's a professor at the University of Florida's College of Pharmacy who has been raising awareness about this issue for two decades.

Dr. Hatton, thanks so much for joining the "News Hour."

I know you and a co-researcher have been looking at this issue for years. I have to ask, why has phenylephrine become so commonplace in cold and flu medicines if it doesn't work and why have we all bought it for so long?

Randy Hatton, University of Florida College of Pharmacy: Yes, you're right.

Dr. Leslie Hendeles and I have been working at this for 20 years when we became aware of problems with oral phenylephrine after pseudoephedrine was moved behind the counter because of concerns where it could be used to make methamphetamine in clandestine laboratories.

So, when pseudoephedrine was moved behind the counter, phenylephrine was substituted for pseudoephedrine and became widely used. And that's when patients started complaining about its lack of effectiveness.

Stephanie Sy:

The FDA has ruled this ingredient safe. So why do you think it's important to get it off the shelves?

Randy Hatton:

Yes, it is safe because essentially it is not absorbed. It is absorbed at less than 1 percent of the dose that it's given. And that's why it doesn't work. So why should it be removed? Because it doesn't work.

Drugs on the market in the United States, whether they're over the counter or prescriptions, have to be both safe and effective. And oral phenylephrine is ineffective.

Stephanie Sy:

So what is the alternative for people that are suffering with colds, especially at this time of year? Is it about a medication with a higher dose of this product? Is it going back to pseudoephedrine, which you mentioned, but is difficult for a lot of folks to get over the counter? Or is it using the nasal spray version of this?

Randy Hatton:

Well, first of all, I would never recommend using higher than the labeled dose for oral phenylephrine products. Many of those products are combination products. And some drugs like Tylenol or acetaminophen that's in those products could be toxic at high doses.

So definitely don't take more than the labeled amount. The only effective oral decongestant that would help with nasal stuffiness is behind the counter. And it's perceived as being a barrier, but, frankly, if you go to where there's a pharmacist, you can get that pseudoephedrine behind the counter in less than five minutes in most cases.

I do believe that if somebody will tolerate using nasal sprays, the spray decongestants are highly effective and can be used briefly, three to five days, during the worst part of a cold, maybe to help someone sleep at night.

There's one called — the brand names are Afrin or Sinex 12 Hour that contains the active ingredient oxymetazoline. Or phenylephrine that is ineffective orally, if it's in a nasal spray, it is effective when sprayed up the nostrils.

Stephanie Sy:

OK. And just to be clear, you can get pseudoephedrine not over the counter, but you don't need a prescription for it. You just have to ask at the pharmacist, right?

I have to ask you this. Aren't there other drugs that all of us can buy at a pharmacy that do not work as advertised? And are you saying that the FDA should also take all of those medications off the shelves?

Randy Hatton:

Yes, I believe there are old over-the-counter products that deserve another look. Just like FDA took a look at oral phenylephrine, some of those old products that were approved using science from decades ago are likely ineffective.

But in order to prove that, I believe that we need the appropriate science that would look at those products and determine whether we should be spending our hard-earned money on products that are ineffective.

Stephanie Sy:

Dr. Hatton, critics of this FDA move say this limits consumer choices. What do you say to that?

Randy Hatton:

So it would limit choice for something that does not work. Why would somebody want the choice of something that does not work?

And, as I said, a drug has to be effective to be approved by the FDA. We would not want a bunch of ineffective products to choose from. That is not choice. Choice would be choosing from effective and safe products that the FDA has reviewed and said works for the indications that we want to use them for.

Stephanie Sy:

Dr. Randy Hatton, thanks so much for sharing your view on this with us.

Randy Hatton:

It's my pleasure. Thanks for inviting me.