Two scientists who took down America’s favorite cold meds: Florida pair have been warning ingredient in some OTC Sudafed and Benadryl doesn’t work for 20 YEARS say they feel ‘vindicated’ after FDA ruling

When the FDA announced last month that the main ingredient in the nation’s favorite cold and flu medicines didn’t work, it was a “vindication” for the two scientists who spent nearly two decades proving it was a failure.

Randy Hatton and Leslie Hendeles have been warning since the 1990s that phenylephrine, found in Sudafed PE or Dayquil Cold and Flu, was as ineffective as a placebo pill that, when swallowed, did not enter the bloodstream to reach to the nose.

Dr. Hendeles, an expert in pharmacokinetics, or the way medications move through the body, was the first to criticize phenylephrine in 1993 in a study that compared the effectiveness of that and other cold remedies, including Pseudoephedrine, the main ingredient in Sudafed.

But despite all its findings pointing to its ineffectiveness since the first report in 1993, the FDA and consumer groups continued to ignore their concerns, insisting that the ingredient was worth keeping on store shelves.

This also kept drug makers happy, as the phenylephrine drug industry made nearly $2 billion in profits last year.

The FDA panel’s unanimous vote agreeing that phenylephrine is ineffective is not binding, but it strongly suggests that the agency could soon follow its advice and withdraw its approval, forcing companies to recall or reformulate their products.

Picture this: You wake up one morning with miserable congestion and a hacking cough, and head to the nearest CVS or Walgreens to pick up a trusty pack of Sudafed PE or Dayquil Cold and Flu.

In 21st century America, when it comes to cold medicines, there is an overabundance of options to choose from. Unfortunately for the average adult who gets two or three colds a year, most of those options are no better than a placebo.

University of Florida pharmacy researchers Randy Hatton and Leslie Hendeles have been exposing the ineffective ingredient in many over-the-counter decongestants called phenylephrine for nearly two decades.

After numerous studies, a thorough analysis of the evidence and a petition calling for the products’ subsequent removal, UF researchers finally scored a victory when the Food and Drug Administration formally recognized last month that the ingredient that has been in the store shelves since the 1930s is “not effective” in standard or even high doses.

The FDA’s announcement that its advisory committee had concluded that phenylephrine was ineffective as an oral decongestant (nasal sprays are still considered very effective) took millions of Americans by surprise.

That included Hatton and Hendeles.

Dr. Hatton told Wall Street Journal: ‘We feel vindicated by something we’ve been working on for almost 20 years and that the FDA staff and advisory committee voted unanimously on what we had been saying for quite some time. “That’s pretty gratifying.”

CVS has decided to recall certain cough and cold medications whose main ingredient is phenylephrine.

Dr. Hendeles said, “It was exciting for me to hear that.”

But other major chains such as Walgreens and RiteAid have told DailyMail.com that they will only remove products from shelves if the FDA requires them to do so.

Phenylephrine came on the market in the 1930s and has been used in more than 260 over-the-counter cold medications since the 1970s. The medication was intended to constrict blood vessels to clear congestion.

However, its effectiveness has been repeatedly questioned, and UF pharmacists are leading the investigation.

Until 2006, the cold medicine Sudafed was the choice of millions of Americans for cold and sinus problems.

Its main ingredient, pseudoephedrine, is a highly sought after chemical precursor in clandestine laboratories that manufacture methamphetamine, a fact that many may not have known until Breaking Bad character Jesse Pinkman appeared in American living rooms.

But many experts did know, including Dr. Hendeles, who He was the author of a study in 1993 That said, phenylephrine in pill form is quickly absorbed in the intestine and eliminated before it can have any effect, making it essentially useless.

In comparison, pseudoephedrine is barely metabolized and 90 percent of it passes into the bloodstream and is carried by the blood to the nose.

With pseudoephedrine now relegated to the back of the pharmacy, behind the counter, most cough and cold medicine manufacturers replaced amphetamine with phenylephrine.

The market for drugs whose main ingredient is phenylephrine is huge, with nearly $1.8 billion in profits last year.

When Sudafed was relegated behind the pharmacy counter in 2006, Dr. Hatton ran a pharmaceutical research lab at the University of Florida where students answered questions from medical professionals about certain medications and worked to find the answers.

Suddenly, they received a flood of calls from pharmacists saying customers were complaining that their cold medicines weren’t working. The lab’s research led them to Dr. Hendeles’ study from 1993. Since his offices were down the hall, it wasn’t long before the two collaborated.

They compiled all the studies they could find on phenylephrine, evaluated them all, and in 2007 concluded that the standard 10 milligram dose was no more effective than a sugar pill.

CVS will begin removing popular oral cough and cold products with phenylephrine as the only active ingredient from its stores. Pictured: Empty shelves at CVS in New York City

The pharmacy chain is voluntarily recalling the products after an FDA advisory panel last month refused to endorse the effectiveness of over-the-counter oral medications made with the ingredient.

They wrote a petition to the FDA asking to increase the standard dosage to 25 mg and rescind approval for the drug’s use in children under 12 years of age. They were not asking the FDA to remove the drug from stores.

An FDA hearing to discuss the issue included testimony from representatives of Schering Plow (now Merck), which at the time manufactured the mega-popular pseudoephedrine decongestant, Claritin-D.

The company conducted several studies on the effectiveness of phenylephrine in 2015 and 2016 and found that the ingredient was not only ineffective at 10 mg, but just as effective. ineffective at a dose four times higher. Only one percent of the drug was active in the bloodstream.

Drs. Hatton and Hendeles seized on these findings and wrote another petition to the FDA in 2015, prompting the agency’s Nonprescription Drugs Advisory Committee to vote unanimously to agree that the ingredient didn’t work, ending nearly two decades. of work of doctors Hatton and Hendeles. ‘ hard work.

Its ruling is not binding, but it strongly suggests that the agency could soon follow its advice and withdraw its approval, forcing companies to recall or reformulate their products.

The ingredient is protected under the FDA’s Generally Recognized as Safe and Effective (GRASE) designation, but a revocation of its approval could mean manufacturers like Bayer and Johnson and Johnson may need to reformulate.

For now, anyone with a cold and a stuffy nose will probably do better with a bowl of chicken soup than a packet of Tylenol Cold & Flu.