An Update on Decongestants to Prepare you for the upcoming cold and flu (?and COVID) season.

Should we be concerned that the FDA has removed phenylephrine from OTC cold medications?

One of the most popular posts on the skeptical cardiologist blog site is entitled “What Cold Medications Are Safe for My Heart.” and was written in 2015.

I updated it yesterday after seeing The NY Times headline “A Decongestant in Many Cold Medicines Is Ineffective.”

I began my 2015 post on cold medicines by discussing decongestants and looking at whether cardiac or hypertensive patients should take the decongestant pseudoephedrine (Sudafed).

Phenylephrine, however, was the decongestant that the FDA found to be ineffective. In their 89 page report, the FDA indicates they have been investigating phenylephrine since 2007!

Lord knows how much money and time was spent deciding that just one compound was ineffective. Can you imagine the dollars needed to prove that almost everything in the billion dollar OTC supplement industry is ineffective?

Presumably, the FDA will eventually ban phenylephrine from cold medications but as I point out my article almost everything in OTC cold medications lacks proof of efficacy.

I advise patients to follow the advice I gave in my article and take the individual components of these multi-component snake oil preparations not the brand name smorgasbord of compounds.

Below is the portion of my cold medication article that deals with decongestants.

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Decongestants

When my patients asked about the safety of cold medications I used to answer "Take anything that does not contain pseudoephedrine."

Pseudoephedrine  (brand name Sudafed) is a decongestant. Over-the-counter cold (OTC) medications that contain it will typically add a D to the title (Nyquil-D for example).

It is often combined with other cold , sinus and flu OTC remedies with names like:

Allegra-D, Alka-Seltzer Plus Cold Medicine Liqui-Gels, Aleve Cold and Sinus Caplets, Benadryl Allergy and Sinus Tablets, Claritin-D Non-Drowsy 24 Hour Tablets, Contac Non-Drowsy 12 Hour Cold Caplets, Robitussin Cold Severe Congestion Capsules, Sudafed  24 Hour Tablets, Triaminic Cold and Cough Liquid, Thera-Flu Cold and Cough Hot Liquid, Tylenol Sinus Severe Congestion Caplets, and Vicks 44M Cough, Cold and Flu Relief.

You won't find pseudoephedrine in an isolated form on the shelves in your local pharmacy because methamphetamine can be produced from it. Laws vary from state to state but at a minimum, you will have to present your driver's license and you will be allowed to purchase a limited amount from the pharmacist.

Sympathomimetic Medications

Pseudoephedrine and methamphetamine are sympathomimetic drugs. Such drugs mimic natural hormones that are part of the autonomic nervous system that is responsible for "flight and fight" activation. When this system is activated the heart rate goes up, the blood pressure goes up and the heart beats stronger.

Other sympathomimetic drugs which have been utilized in OTC cold preparations include

• Ephedrine.

• Phenylephrine.

(Phenylephrine was just (Sept/2023) declared by the FDA as ineffective and likely will be removed from such products from now on.)

Sympathomimetic drugs like pseudoephedrine have systemic effects on the cardiovascular system. Blood vessels constrict to the nose and sinuses, thereby reducing fluid buildup and resulting in the "decongestant" properties of the drug. Blood vessle constriction occurs throughout the body, however, which has raised concerns that this may result significant worsening of hypertension or increase stroke risks.

A related drug, phenylpropanolamine, (which was used in OTC cold remedies and for weight loss)  was removed from the market in 2000 after the FDA warned of an increased risk of hemorrhagic stroke in young women.

Most of this stroke risk was in women taking appetite suppressants and no effect was seen in men taking OTC cold medications (see here.)

Adverse Effects of Pseudoephedrine: Stroke, Blood Pressure, Heart Rate?

A 2003 paper from Mexico identified 22 cases of stroke (out of 2500 stroke cases at their center) that were associated with taking agents like pseudoephedrine within 24 hours. The majority were with phenylpropanolamine but there were 4 cases associated with pseudoephedrine.

Given how often pseudoephedrine is taken and how few strokes were reported, it is difficult to draw any conclusions that pseudoephedrine causes stroke from this study.

In 2005, a review of all studies looking at oral pseudoephedrine concluded

This analysis demonstrates that pseudoephedrine causes a small but significant mean (1–mm Hg) increase in SBP, with no significant effect on DBP and a slight increase in HR (3 beats/min)...

Patients with stable, controlled hypertension do not seem to be at higher risk for BP elevation as a group than other patients when given pseudoephedrine along with their antihypertensive medications

On average, these are very minor changes in blood pressure and heart rate and would be unlikely to cause any problems in the vast majority of patients with significant heart disease or hypertension.

The study found NO increased rate of adverse effects (such as heart attacks or strokes) in the patients taking pseudoephedrine.

Pseudoephedrine: Although it is pseudo it safe and effective!

After reviewing the literature back in 2015 I stopped advising my patients from taking pseudoephedrine.

Personally, I find pseudoephedrine to be quite effective. Also, I have hypertension and have checked my home blood pressure both on and off pseudoephedrine and found no increase when taking it.

I use the little red 30 mg Sudafed pills when my nose is really running badly (think 30 tissue/ hour) and I'm sneezing frequently and it dries me up pretty effectively.  After I take it I feel like I've consumed a really highly caffeinated (think Starbucks) cup of coffee for about 4 hours

For this reason, I don't take it within 6 hours of going to bed.

Unsniffingly Yours,

-ACP

N.B. The NY Times article leads with a picture of what appears to be little red Sudafed pills (the decongestant that is not banned.) It makes several other errors but there is a good discussion on nasal decongestants and nonpharmacologic methods of decongestion you should check out. My allergist at SLU, Dr. Mark Dykewicz, is quoted extensively.