The following report is by The New York Times:
An advisory panel to the Food and Drug Administration agreed unanimously on Tuesday that a common decongestant ingredient used in many over-the-counter cold medicines is ineffective.
The panel’s vote tees up a likely decision by the agency on whether to essentially ban the ingredient, phenylephrine, which would result in pulling hundreds of products containing it from store shelves.
If the F.D.A. ordered their removal, a trade group warned that numerous popular products — including Tylenol, Mucinex and Benadryl cold and flu remedies — might become unavailable as companies race to reformulate them.
Agency officials generally follow the recommendations of the advisory panels, though not always, and it could take some months before a final decision is made. And the findings could be contested, prolonging any move toward product substitutions or removing certain stock at stores.
In the meantime, experts advised consumers not to panic or toss out all the drugs in their medicine cabinet. Even though the agency’s advisers have decided the ingredient, phenylephrine, doesn’t work to relieve nasal congestion when taken orally, it is not dangerous, and the products do contain other ingredients that will work to ease cold symptoms.
The panel’s vote followed its review on Monday and Tuesday of several existing studies, with the advisers largely concluding that the research settled the question that the ingredient was useless and no better than a placebo.
Several advisers noted that patients taking the drug were merely delaying their journey to a useful remedy.
I think we clearly have better options in the over-the-counter space to help our patients, and the studies do not support that this is an effective drug.
Maria Coyle, the chairwoman of the panel and an associate professor of pharmacy at Ohio State University, said
If you have a stuffy nose and you take this medicine, you will still have a stuffy nose.
Said Dr. Leslie Hendeles, a pharmacist from the University of Florida in Gainesville who, along with colleagues, first petitioned the F.D.A. in 2007 to remove the drug from the market.
Every cold and flu season, millions of Americans reach for these products, some over decades. The decongestant is in at least 250 products that were worth nearly $1.8 billion in sales last year, according to an agency presentation. Among the products: Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max and others.
There are two main oral decongestants in products on store shelves — phenylephrine and pseudoephedrine.
Under old, outdated agency standards, phenylephrine, which constricts blood vessels in the nasal passages, had long been considered safe and effective, and the F.D.A. still says that it is safe.
Nasal sprays that contain the ingredient are still considered effective, as well as when it is used in surgery or to dilate the eyes. Nasal sprays containing another ingredient, oxymetazoline, are also effective for a stuffy nose.
Other medicines to ease congestion for the common cold include those containing oral pseudoephedrine, and for hay fever or allergic rhinitis, nasal steroids, such as Flonase, as well as nasal antihistamines and oral pseudoephedrine.
Many popular cold and flu products that don’t specifically target congestion do not include the ingredient.
If the agency decides the decongestant should be eliminated from products, it could significantly disrupt the market for the makers of cold medicines if they do not have enough time to replace it in popular items.
What’s more: It could possibly renew widespread use of an alternative, pseudoephedrine, whose sales are restricted — placed behind store counters or in locked cabinets because it was often used in illicit meth labs.
As a result, buying pseudoephedrine products can be a clunky, time-consuming process. Even though they don’t require a prescription, they are kept out of customers’ reach, the number of tablets that can be purchased at one time is capped, and consumers must be 18 or over and show identification.
There are also side effects associated with pseudoephedrine, which can raise blood pressure, and cause jitters and wakefulness, Dr. Hendeles said.
This issue has been simmering at the F.D.A. for decades.
Now an emeritus professor, Dr. Hendeles said in an interview on Tuesday that he had been evaluating the ingredient since 1993.
The bottom line is quality research has told the true story about phenylephrine.
He said.
For consumers, the potential benefits of ending use of the ingredient, the agency suggested, would include avoiding unnecessary costs or delays in care by “taking a drug that has no benefit.”
Although there is no known health risk associated with taking a combination cold medicine that contains phenylephrine, consumers unable to get relief from a single dose should not take additional doses in a short span of time to feel better. Higher levels of the other ingredients may be dangerous when taken in excess, experts cautioned.
The Consumer Healthcare Products Association, which represents companies that make over-the-counter drugs, took issue with the panel’s recommendation on Tuesday, issuing a statement that the ingredient was both safe and effective. The organization said pulling the ingredient would have the “negative unintended consequences” of sending patients to doctors and pharmacists for problems they might otherwise treat themselves — or of getting no treatment at all.
Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. health care system.
According to the statement from Marcia D. Howard, the group’s vice president of regulatory and scientific affairs.
It could be a while before any changes are announced.
But the agency has already shown its hand, by declaring the ingredient ineffective. But now, F.D.A. officials will mull the comments and opinions of its panel experts before preparing a final decision.
As often happens whenever the F.D.A. is poised to impose a regulatory move that will affect the bottom line of major corporations, efforts to delay a decision, including lawsuits and lobbying Congress and the White House, will probably occur. The agency also may give the drug companies a grace period to swap ingredients in products, if required.
AUTHOR COMMENTARY
I think it is noteworthy to consider the timing of this ruling: at a time when the Biden administration and the media are pushing more Covid hysteria and urges to get vaccinated with the latest Covid-19 death shot. No cold drugs for you, only gene-altering mRNA shots.
But putting that aside, some things never change now do they?
[25] And a certain woman, which had an issue of blood twelve years, [26] And had suffered many things of many physicians, and had spent all that she had, and was nothing bettered, but rather grew worse, [27] When she had heard of Jesus, came in the press behind, and touched his garment. [28] For she said, If I may touch but his clothes, I shall be whole. Mark 5:25-28
The sorcerers – (and they are sorcerers, witchdoctors, per the definition of those words and the Greek word ‘”Pharmakeia” from which those words are derived from) – of Jesus day are no better than those of today, but only worse.
This article by the NYT and others only highlight just a small slimmer of just how corrupt the medical establishment is and has been; peddling drugs, elixirs, potions, and phony cures for years on end via their pharmacists, “doctors,” and nurses; who traded in their Druidic robes for a white coat and a fat check!
If you are like me we ditched these useless and harmful “cures” to the curb years ago. I take this news personal as I reminisce about how I used to take so many of these decongestants, as if I were mowing down on Halloween candy. I used to be sick so frequently and for so long. I never knew what ‘normal’ was because I was fed a crap diet with next to no nutrition in it, and was popped pills and magic potions week-in and week-out, to no avail, spending weeks just to overcome nasty cases of the sniffles.
Praise the Lord God Almighty for saving me and giving me his Holy Spirit to lead me into all truth, because once I got saved at the near age of 15 the Lord immediately started to help me cure myself. Fast forward to the present and I do not take these pharmaceuticals, I have not been sick in many years, and I am easily in the best shape of my life and continuing.
A wicked messenger falleth into mischief: but a faithful ambassador is health.
Proverbs 13:17
[7] Who goeth a warfare any time at his own charges? who planteth a vineyard, and eateth not of the fruit thereof? or who feedeth a flock, and eateth not of the milk of the flock? [8] Say I these things as a man? or saith not the law the same also? [9] For it is written in the law of Moses, Thou shalt not muzzle the mouth of the ox that treadeth out the corn. Doth God take care for oxen? [10] Or saith he it altogether for our sakes? For our sakes, no doubt, this is written: that he that ploweth should plow in hope; and that he that thresheth in hope should be partaker of his hope. (1 Corinthians 9:7-10).
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I will not be sad to see Tylenol products leave the store shelves and any reformulation they would do I would not trust. I just got over the worst of people used to call a summer cold with some zinc lozenges. I’m actually glad I got the cold, since I had not had as much as the sniffles for about 10 years, and I might have brought the cold on myself by taking some lymph drainage product. I had my tonsils taken out as a child, so I once in a while take something to help do what those tonsils were made to do in the first place. I think for the most part doctors have abandoned performing tonsillectomys, but it was a common practice for the boomer generation.