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AN ANGRY ANGELENO - First, the legal disclaimer: I am NOT a medical doctor NOR a pharmacist. You should consult a medical doctor before making any changes to your medication regimen, both prescribed and over-the-counter medicines.
This is a column about OTC or (nonprescription) over-the-counter medicines and (what I'll call) hybrids, medicines that don't require a prescription, but that require a CA drivers license at the pharmacy counter.
Way back on September 12, 2023, AP (wire service Associated Press) reported that “Popular Nasal Decongestant Doesn't Actually Relieve Congestion, FDA Advisers Say”.
We are ONLY talking about the ORAL form of this decongestant, NOT the nasal spray (or drops) form.
Just from the caption of that story's lead pic (which shows medications that contain pseudoephedrine behind the counter at a pharmacy) we can find out that the drug the title refers to is “phenylephrine, is ineffective at relieving nasal congestion. Drugmakers reformulated their products with phenylephrine [sometimes abbreviated as “PE” on packages] after a 2006 law required [medications with pseudoephedrine to] be sold from behind the pharmacy counter.”
You see, illegal drug traffickers were buying cheap decongestant cold medicine (blister packs of tiny red pills) by the boatload to cook up batches of the horrible drug crystal meth, which destroys the human brain.
Now, I had suffered from year-round allergies for decades and had always used the leading OTC decongestant, tried-and-true pseudoephedrine HCl (hydrochloride). The drugmakers made the switch because it was a significant purchase barrier for customers to go to the pharmacy counter and wait in line with a drivers license to buy a box of decongestant. They make you take the ID out of your wallet and hand copy the info or swipe the ID and you're limited to a certain amount per month (the info goes into a database). All of this will discourage sales, of course, so drugmakers quickly found a substitute (perhaps too quickly) for pseudoephedrine that did not have all this work involved for purchases. So, you can buy a box with the inferior decongestant or you can wait in line, ID in hand, and buy “the (original) good stuff” (as I refer to it) from the Pharmacy counter.
Sudafed, the most famous brand name for decongestant and products containing a decongestant, is sold with either of the two, both over-the-counter and behind-the-counter (and here I'm not referring to behind-the-counter for anti-theft purposes) depending on whether the heavily regulated ingredient is present. There are also Sudafed products that contain other ingredients like an expectorant (generic Mucinex), a cough suppressant, and a pain reliever/fever reducer (generic Tylenol) in various combinations. There are other brands that contain these ingredients in various combinations. Then there are generic or store brands. You look at the box's Drug Facts, Active Ingredient and Purpose, box. It also shows you the quantity of that ingredient in each pill. Doing that, I learned that the active ingredient in Benadryl is the same active ingredient as a leading OTC sleep aid, which explains why Benadryl makes you sleepy.
When the drugmakers switched their OTC decongestant-containing products to phenylephrine roughly 2 decades ago, I already had an old Chemistry degree. My attitude was: “Why would I switch from something that works great and appears to be relatively safe (from so many years of use by the general public) just because people are using it to manufacture an illegal drug (which happens to be VERY dangerous to your brain). They are switching to a lesser active ingredient simply because that makes it harder to synthesize crystal meth. Well that isn't a good reason for me to take that lesser option, just because it cannot be made into crystal meth easily. I want a choice of medicine that prioritizes relieving my congestion.” So, I never made the switch.
Turns out that I was right. Oral “PE” decongestant doesn't work...so says the FDA. I think products that contain it should have been pulled off store shelves a YEAR AND A HALF AGO and replaced with either products that do work or a big sign telling people to line up at the pharmacy counter with ID in hand to get the good oral decongestant that does actually work.
Has the industry found a working substitute that actually decongests and cannot easily be made into crystal meth? Will the almost 2 decades of ineffective decongestant use lead to massive Class Action Lawsuits, not only for the price of the boxes purchased but also for further losses suffered like unrelieved congestion leading to hospitalization or worse? These are important questions.
But I'm writing this to inquire, “Why are these boxes still on store shelves?” Roughly a year ago, I actually pointed them out at a mom-and-pop pharmacy, told them about the FDA, and told them that they should be removed from the store's shelves.
I recently read another article that said CVS did pull these products off shelves, but most other pharmacies have not. I have not checked CVS, but I did take photos of products containing PE as the decongestant earlier this week at Target.
[INSERT PICTURES HERE]
I'll leave you with a few key quotes from the September 2023 AP (Associated Press) article.
“This week’s two-day meeting was prompted by University of Florida researchers who petitioned the FDA to remove most phenylephrine products based on recent studies showing they failed to outperform placebo pills in patients with cold and allergy congestion. The same researchers also challenged the drug's effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.”
So, basically, the efficacy of oral PE decongestant was being challenged even earlier, roughly TWO DECADES AGO, right after the switch.
“This time, the 16 members of the FDA panel unanimously agreed that current evidence doesn’t show a benefit for the drug.”
“Additionally, three larger, rigorously conducted studies published since 2016 showed no difference between phenylephrine medications and placebos for relieving congestion. Those studies...enrolled hundreds of patients.”
Why wasn't oral PE decongestant pulled from store shelves (and taken out of combo products) after those studies?
Something tells me it has something to do with Money and Greed.
(“The Angry Angeleno” is the nom de plume of Yuval Kremer. Yuval is a Registered Democrat; a Cali-Camp, Harvard-Westlake (pre-merger), USC, and Loyola Law School Alum; and a former ballot candidate for Mayor of LA (failing to prevent Mayor Garcetti's reelection) and LA County Supervisor (ran against Sheila Kuehl, Katy Yaroslavsky's former boss). The opinions expressed by Yuval are his and his alone (not those of CityWatchLA), but will likely be yours soon!)
