When the FDA announced last month that the main ingredient in the nation’s favorite cold and flu medicine doesn’t work, it was “vindication” for the two scientists who have devoted nearly two decades to proving it silly.
Randy Hutton and Leslie Hendeles have been warning since the 1990s that phenylephrine—found in Sudafed PE or Dayquil ColdandFlu—was ineffective as a placebo pill that, when swallowed, did not enter the bloodstream to go to the nose.
Dr. Hendeles, an expert in pharmacokinetics, or the way drugs move through the body, was the first to criticize phenylephrine in a 1993 study that compared its effectiveness to other cold medications, including pseudoephedrine, the main ingredient in Sudafed.
But despite all their findings pointing to its ineffectiveness since the first report in 1993, the FDA and consumer groups have continued to dismiss their concerns, insisting the ingredient is worth keeping on store shelves.
This has also kept drug makers happy, given that the phenylephrine drug industry raked in nearly $2 billion in profits last year.
Dr. Leslie Hendeles [shown left] and Dr. Randy Hutton [right] pressured the FDA to take action on ineffective phenylephrine for nearly two decades before the agency agreed last month that the ingredient was no better than a placebo
The FDA panel’s unanimous vote agreeing that phenylephrine is ineffective is not binding, but it strongly suggests that the agency may soon take their advice and withdraw its approval, forcing companies to withdraw or reformulate their products.
The FDA’s announcement on September 12 that its advisory committee had concluded that phenylephrine was ineffective as an oral decongestant (nasal sprays are still considered very effective) surprised millions of Americans.
That included Hutton and Hendeles, both professors of pharmacy at the University of Florida.
Dr. Hutton told the Wall Street Journal: We felt vindicated for something we’ve been working on for nearly 20 years, and the FDA staff and advisory committee voted unanimously for what we’ve been saying for a long time. So it’s quite rewarding.
CVS has decided to recall certain cough and cold medicines whose main ingredient is phenylephrine.
Dr. Handels said, “That was exciting for me to hear.”
But other major chains, such as Walgreens and RiteAid, told DailyMail.com they would only pull products from shelves if the FDA asked them to.
Phenylephrine came on the market in the 1930s and has been used in more than 260 over-the-counter cold medicines since the 1970s. The drug was supposed to constrict the blood vessels to clear the congestion.
By 2006, the cold medicine Sudafed was used by millions of Americans for colds and sinus problems.
Its main ingredient, pseudoephedrine, is a highly sought-after chemical precursor in secret labs for the production of methamphetamine, a fact that many may not have known until Breaking Bad character Jesse Pinkman appeared in Americans’ living rooms.
But many experts knew, including Dr. Handeles, who had already discovered that phenylephrine in pill form is rapidly absorbed in the gut and eliminated before it has any effect, rendering it essentially worthless.
In comparison, pseudoephedrine is hardly metabolized at all, and 90 percent of it goes into the bloodstream and is carried by the blood to the nose.
Since pseudoephedrine has now been relegated to the back of the pharmacy behind the counter, most cough and cold medicine manufacturers have replaced amphetamine with phenylephrine.
At the time, Dr. Hutton ran a pharmacy research lab at UF where students asked medical professionals questions about specific drugs and worked to find the answers.
They were suddenly getting a flurry of calls from pharmacists saying customers had complained that their cold medicine wasn’t working.
Dr. Hutton’s laboratory research led to Dr. Hendeles’ 1993 study. Since their offices were far apart, it didn’t take long for the two to work together.
They compiled every study they could find on phenylephrine, evaluated them all, and concluded in 2007 that a standard dose of 10 milligrams was no more effective than sugar pills.
CVS will begin pulling popular oral cough and cold products with phenylephrine as the sole active ingredient from its store shelves. Pictured: Empty CVS shelves in New York
The drugstore chain voluntarily removed the products after a panel of FDA advisers last month refused to support the effectiveness of over-the-counter oral medications made with the ingredient.
They petitioned the FDA to increase the standard dose to 25 mg and revoke the drug’s approval for use in children 12 years of age and younger. They did not ask the FDA to pull 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 megapopular 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 was just as ineffective at four times the dose. Only one percent of the drug was active in the bloodstream.
Drs Hutton and Hendeles pounced on these findings and wrote another petition to the FDA in 2015, leading the agencies’ over-the-counter drug advisory committee to vote unanimously to agree that the ingredient did not work, ending some two decades of doctors Hutton and Hendeles. hard work.
Dr Hendeles said: “It’s a big lesson for people to learn and they should ask their pharmacists before taking a product. So that’s one thing that drug companies are learning is that they have to answer the question of why are they selling something that they know isn’t effective?’
Their ruling is not binding, but it strongly suggests that the agency may soon heed their advice and withdraw its approval, forcing companies to recall or reformulate their products.
The ingredient is protected by the FDA’s Generally Recognized as Safe and Effective (GRASE) designation, but revoking its approval could mean that manufacturers, including Bayer and Johnson & Johnson, may have to reformulate it.
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.
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