Hey, thanks so much for joining us here on nine news plus, I'm Chris Bian
and FDA advisory committee voted on Tuesday that the
ephrine isn't
effective as and de congested. Now,
I just said a bunch of big words,
but I'm going to kind of clarify this and why this is significant for starters.
The
that is a common ingredient in cold medicines and it might mean that
it could be removed from store shelves that could mean things like Tylenol,
uh, as well as
things like that could be removed from store shelves in the coming weeks.
And joining us from a bit more about this potentially significant development
is Leticia Shea from Regis University and we appreciate you joining us
and giving us a bit of insight about this potentially significant development.
Um II I suppose Leticia, before we get into anything else
for stories that I get that overview? Right. And two,
do you think that this will ultimately lead to a lot
of those common cold medicines being removed from store shelves?
There are a lot of cough and cold medications that have phenylephrine
in them. So if it's decided upon that it is going to be removed.
It's likely there will be a lot of medications that are pulled from the market,
especially really popular ones like,
ok, so to be clear,
it's, that
is ineffective, right?
Not that it's dangerous, but it's just that it's basically a placebo, is that it?
Well, yes,
that's predominantly what they found is that at
the dosing available of 10 mg of phenylephrine,
that's usually what the dose is or below that
in combination products that it has not really shown
to be more effective than placebo in some trials.
Ok. And
pylori
is commonly found in cold medicines. I mentioned Tylenol Dayquil,
what are some other ones? And would again, this
potentially lead to those being removed from store shelves.
I think it would if that's what they decide to do. Oral pylori
is a decongestant. And so it's used to help with congestion of the nasal mucosa.
And so if any products that you know, provide aid with,
maybe if it says sinus pressure or sinus aid, it might have phenylephrin
inside it.
As most of them have combinations, phenylephrin
and
acetaminophen are usually you said Tylenol,
which is a brand name for acetaminophen
and
Plein is usually combined with
acetaminophen and maybe some other
cough products such as dextromethorphan
in general, it's in combination products. And so
it used to be P Sudafed
that was found in these combination products.
But when they made Sudafed go behind the counter where you would need a
driver's license to obtain it because it
was associated with the making of methamphetamine.
They replaced that ingredient in these combination products with Beri.
So,
unless they find another product, I think a lot of them are not going to have, be
available.
Um, what does that mean?
So for example, these common cold medicines,
does that mean over the years that they've been essentially placebos
are kind of not particularly helpful in decongestants or are there other
products within some of those medicines like Tylenol like Aquil, for example,
that are effective at reducing congestion?
No, the only thing that's effective for reducing congestion over the counter.
It depends too.
I think when you say congestion,
it's important to us to think about what is causing the congestion.
So if we have congestion that's caused based on
allergy symptoms or allergy mediators, then
you might have a response from Flonase
or fluticasone
or
intranasal steroid.
But if it's just a cold symptom, that's, you know, it's a cold caused congestion,
then the really you need a decongestant and sued
which is behind the counter is an effective decongestant to,
to help with congestion as well as intranasal deco
like Oxymetazoline,
that one will still be available, but it's intranasal, it's not.
So the issue that we're having is with oral
products and so oral products that have phenylephrine,
are they effective? Likely not,
at least that's what the studies show, but you know,
placebo is super strong and there's other
ingredients in them that might provide some,
some benefit.
Um, acetaminophen
for pain relief, Dexmoor
to help with cough.
Although it's really not that effective, especially in combination,
most of the combination products are subtherapeutic.
So rather than getting a full dose that they need, you're getting a smaller dose,
but with a combination of other products,
so they're not entirely, those things aren't
entirely worthless. There's other benefits to them. It's just that
maybe the behind the counter ones, at least the way things are right now, again,
you mentioned Pseudofed,
which you can't get over the counter anymore because of the possible links to
methamphetamine as you mentioned.
But it's the over the counter ones right now that have
other uses to them besides de congestion a little bit.
But really, the studies aren't there. You know, we're focusing on Strine
right now because
really,
it's been known to be pretty close to Placebo since I think a lot of
studies came out in 2007 and they came out in 2007 because that was when
had to go behind the counter.
And so these combination products had to come up with a decongestant and
was around since the 1970 1974 was approved. But
for 50 years, it's been around for a long time, just not that effective.
So it was Sudafed, that was in those products.
But when Sudafed had to go behind the counter,
they had another product that was available.
2007 is a long time. It's been 16 years. How come these
medicines have been?
It will be sold for, gosh, knows, millions,
probably billions of dollars in that time frame.
I know. I don't know. We, we've known it,
I think you said something in the beginning, you know,
um,
we don't know about efficacy but generally we're thinking in the
adult population we're not finding too much harm associated with it.
Although there is harm with decongestants that are used in certain populations,
it increases, you know, it's a sympathomimetic which means it stimulates your,
your system,
which is, in other words, your fight or flight.
And so for individuals with high blood pressure or cardiovascular risk,
we really don't want them taking oral decongestants anyhow,
we want to increase their blood pressure. And so
there are certain populations that de congestion is never safe in regardless.
But in the general population,
I think
10 mg or less of
phenylephrine generally well tolerated efficacious,
probably not but tolerated.
Sure.
Ok. So maybe with all this in mind,
it's a possible solution, so to speak.
So let's say you do have a runny nose and I know you mentioned,
it depends on whether we're talking about allergy,
whether we're talking about a common cold or other factors behind it.
What would you generally recommend for somebody
if they have a runny nose?
I think the best thing you can do if you have a ray nose and you're feeling crummy
is intranasal saline, which I know is like, oh, it's awkward.
You gotta pour something on,
you know, clean out your nostril,
but it's actually been shown to be fairly effective and
it decreases the length of time.
A patient is sick as well as minimizes their symptoms.
Um It's also been shown to reduce the need for medication, which is always a benefit.
So something safe a little bit awkward.
But I think intranasal saline is a great way
to go if you're really miserable with congestion.
Now, congestion is, is more of just a running nose.
It's where, you know, it's that nasal mucosa is,
it feels full but you can't do much about
it. Um Intranasal
or
intranasal.
Oh, what are they called intranasal decongestant such as oxymetazoline
still effective for doing that.
But you have to be careful not to
overuse those because then you get rebound congestion.
Ok.
So,
so generally the tube up the nose is the best.
The same irrigation, the net,
although
I haven't seen any pot for a while,
but a lot of times it's the saline rinse that comes in a squeeze bottle.
I mean, you squeeze through one nostril, clear it out, use the other nostril.
Just make sure you use clean water,
distilled water or water that's boiled first because
we don't want to introduce any microbes.
If we had to
go to medication, let's say people don't want to do that.
We're heading, we're recording this year in September.
Let's say we're heading into winter.
What are possible options you mentioned, Sudafed,
is that something you recommend?
Sudafed is effective.
It's been shown to be an effective decongestant, oral decongestant.
So, yes, you just need your driver's license,
go to the pharmacy and get some Sudafed.
But another beneficial thing about that is you only taking one product,
not a combination of products likely for things that you're not experiencing
the cold has, you know, a variation of symptoms throughout its course.
And generally you're having, you know, in the beginning, sometimes a sore throat
and pain discomfort.
You take Tylenol or Ibuprofen if appropriate in the beginning.
But then when you get the congestion or the runny nose,
then you can take Sudafed for that.
But you don't have so much of that sore throat symptom anymore.
So rather than taking drugs that you don't need,
you focus on the symptom presenting.
So during that time when you have congestion, you can take oral decongestant.
As long as you don't have high blood pressure or cardiovascular risk.
Obviously know that first and foremost any final things we should know about,
about
and its possible removal here from the market
and what people should do when they're decongestant
or congestion at this point.
Yeah, I think, you know, if you, you have congestion, evaluate,
why do I have congestion is because I have allergies or is
it because I have a cold if I have a cold,
it's going to be for, you know, a week of time of misery.
So, is a decongestion appropriate for you. If so, then sued
is available just behind the counter if it isn't
available or if it's not appropriate for you.
Saline rents is a great option.
Um If it's allergy mediated Flonase
is great intranasal steroids as well as over the counter just recently.
Um Intranasal antihistamine asta
pro
is helpful for congestion associated with allergy mediated symptoms.
If it is just a cold, you've got your saline rinse,
you've got intranasal decongestant such as Oxymetazoline
and I'd recommend that one because it's a 12 hour. And so that way
you do it once, try not to use it more than for three days.
So you don't get rebound congestion.
Ok. So there are alternatives out there.
And so
we're prepared in the event that a lot of those over the counter
medications like Tylenol, like
again,
removed. So that's good news. Right. Yeah, there's plenty of options. All right.
Well, we appreciate
she from Regis University. Appreciate a few minutes of your time here on nine
plus.
I'm excited to be here. Thank you. Thanks for having us.