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

• University of Florida pharmacists have been calling for FDA action since 2006
• The FDA’s panel of experts finally agreed with them at a meeting last month.
• Read more: CVS discontinues popular, ineffective over-the-counter cold medicines

When the FDA announced last month that the main ingredients in this country’s popular cold and flu medicines didn’t work, it was a “vindication” moment for two scientists who have dedicated nearly two decades to proving that it was a failure. ization.”

Randy Hutton and Leslie Henderes have been warning since the 1990s that the phenylephrine in Sudafed PE and Daquil Cold and Flu is as ineffective as a placebo pill, which when ingested does not enter the bloodstream and reach the nose. .

Dr. Henderes, an expert in pharmacokinetics, or how drugs move through the body, conducted a 1993 study comparing the effectiveness of phenylephrine with other cold medicines, including pseudoephedrine, the main ingredient in Sudafed. , was the first to criticize phenylephrine.

But since the first report in 1993, the FDA and consumer groups have continued to ignore concerns and insist that the ingredient deserves to be on store shelves, despite all research pointing to its ineffectiveness.

That was good news for drug makers, too, considering the phenylephrine drug industry earned nearly $2 billion in profits last year.

On September 12, the FDA announced that an advisory committee had concluded that phenylephrine was ineffective as an oral nasal decongestant (nasal sprays are still considered highly effective). It shocked millions of Americans.

Among them were Hutton and Hendeles, professors of pharmacy at the University of Florida.

Dr Hutton said: wall street journal: “When FDA staff and advisory committees unanimously voted to do what we have been saying for quite some time, we felt vindicated for what we have been working on for nearly 20 years. So it’s very rewarding.”

CVS has decided to discontinue certain cough and cold medicines that contain phenylephrine as the main ingredient.

“I was very happy to hear that,” Dr. Handeres said.

However, other major chains such as Walgreens and Rite Aid told DailyMail.com that they would only pull the product from their shelves if the FDA required it.

Phenylephrine entered the market in the 1930s and has been used in more than 260 over-the-counter cold medicines since the 1970s. This drug was intended to constrict blood vessels and relieve congestion.

Until 2006, the cold medicine Sudafed was the go-to for millions of Americans’ cold and sinus problems.

Its main ingredient, pseudoephedrine, is a highly sought-after chemical precursor in secret laboratories that manufacture methamphetamine, a fact that was not known until Breaking Bad character Jesse Pinkman showed up in Americans’ living rooms. Many people may not have known.

However, many experts, including Dr. Handeles, had already discovered that phenylephrine in pill form is rapidly absorbed in the intestines and excreted before it takes effect, rendering it essentially worthless.

By comparison, pseudoephedrine is poorly metabolized and 90% of it enters the bloodstream, where it is carried to the nose.

With pseudoephedrine relegated to behind the pharmacy counter, most cough and cold medicine manufacturers replaced amphetamines with phenylephrine.

At the time, Dr. Hutton ran a pharmaceutical lab at the University of Florida, where students answered questions from medical professionals about specific drugs and researched them to find answers.

Suddenly, pharmacists were inundated with calls from customers complaining that their cold medicine wasn’t working.

Research in Dr. Hutton’s lab led to Dr. Handeres’ 1993 study. Their offices were across the hall, so it didn’t take long for them to work together.

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

They petitioned the FDA to increase the standard dose to 25 mg and to revoke the drug’s approval for use in children 12 years and younger. They were not asking the FDA to remove the drug from store shelves.

FDA hearings to discuss this issue included testimony from representatives of Schering-Plough (now Merck & Co.), which manufactured Claritin D, the then-hyperpopular pseudoephedrine decongestant.

The company conducted several studies on phenylephrine’s effectiveness in 2015 and 2016, and found that the ingredient was not only ineffective at 10 mg, but completely ineffective. No effect at 4 times the dose. Only 1% of the drug was active in the bloodstream.

Dr. Hutton and Dr. Hendeles jumped on these findings and petitioned the FDA again in 2015, resulting in the FDA’s OTC Advisory Committee unanimously agreeing that the ingredient was ineffective. This brings to an end nearly 20 years for Dr. Hutton and Dr. Henderes. “Thank you for your hard work.”

“This is a big lesson for people to learn, and they need to ask their pharmacist before they pick up any product,” Dr. Hendeles said. So what we’re learning is that drug companies have to answer the question of why they sell something they know doesn’t work. ”

Although their rulings are not binding, they strongly suggest that government agencies may soon heed their advice and revoke approvals, forcing companies to discontinue or reformulate their products.

The ingredient is protected under the FDA’s Generally Recognized as Safe and Effective (GRASE) designation, but if approval is revoked, manufacturers like Bayer and Johnson & Johnson will have to reformulate it. there is a possibility.

Right now, if you’re cold and have a stuffy nose, you’ll probably be better off with a cup of chicken soup than a Tylenol cold and flu pack.