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 key ingredient in the nation’s favorite cold and flu drugs didn’t work, it was a “vindication” for the two scientists who dedicated nearly two decades to proving it was a dud.

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 taken, did not enter the bloodstream and went to the nose.

Dr. Hendeles, an expert on pharmacokinetics, or the way drugs move through the body, was the first to criticize phenylephrine in 1993 in a study comparing its effectiveness to other, more common cold medications, including pseudoephedrine. the main ingredient of Sudafed.

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

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

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

The FDA’s announcement on September 12 that its advisory committee had concluded that phenylephrine was not effective as an oral decongestant (the nasal sprays are still considered highly effective) surprised millions of Americans.

This included Hatton and Hendeles, both professors of pharmacy at the University of Florida.

Dr. Hatton told the Wall Street Journal: ‘We felt vindicated for something we’ve been working on for almost 20 years and that the FDA staffers and the advisory committee voted unanimously on what we’ve been saying for a long time. So that’s quite worthwhile.’

CVS has decided to discontinue certain cough and cold medications, the main ingredient of which 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 pull products from their shelves if the FDA requires them to do so.

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

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

The key ingredient pseudoephedrine is a highly sought after chemical precursor in clandestine labs that produce methamphetamine, a fact that many may not have known until Breaking Bad character Jesse Pinkman appeared in Americans’ living rooms.

But many experts did know, including Dr. Hendeles, who had already discovered that phenylephrine in pill form is quickly absorbed and eliminated in the intestines before it can have any effect, making it essentially worthless.

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

Now that pseudoephedrine has been moved to the back of the pharmacy behind the counter, most cough and cold medicine manufacturers have replaced the amphetamine with phenylephrine.

At the time, Dr. Hatton headed a pharmaceutical research laboratory at UF, where students answered questions from medical professionals about certain medications and worked to find the answers.

They suddenly started getting an influx of calls from pharmacists saying customers had complained that their cold medicines weren’t working.

Dr. Hatton’s lab’s research led them to Dr. Hendeles’ 1993 research. Because their offices were down the hall from each other, it wasn’t long before the two were able to work together.

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

CVS will begin pulling from store shelves popular oral cough and cold products that contain phenylephrine as the only active ingredient. Pictured: Empty CVS shelves in New York City

The pharmacy chain is voluntarily removing the products after a panel of FDA advisors last month declined to support the effectiveness of oral over-the-counter medications made with the ingredient

They wrote a petition to the FDA asking it to increase the standard dose to 25 mg and revoke approval for the drug’s use in children 12 years and younger. They did not ask the FDA to remove the drug from store shelves.

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

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

Dr. Hatton and Hendeles seized on these findings and wrote another petition to the FDA in 2015, which led to the agency’s Nonprescription Drug Advisory Committee voting unanimously to agree that the ingredient didn’t work, marking the end of about two decades. from Dr. Hatton and Hendeles was completed. ‘ hard work.

Dr. Hendeles said, “That’s a big lesson for people to learn and they should ask their pharmacists before picking up a product. So that’s one thing the drug companies are learning: they have to answer the question: Why are they selling something they know is not effective?’

Their ruling is not binding, but strongly suggests that the agency could soon take their advice and withdraw approval, forcing companies to withdraw or reformulate their products.

The ingredient is protected under the FDA’s GRASE (General Recognized as Safe and Effective) designation, but a recall of the approval could require manufacturers including Bayer, Johnson and Johnson to reformulate the formula.

For now, anyone with a cold and stuffy nose would probably do better with a bowl of chicken soup over a pack of Tylenol Cold & Flu.