When the FDA announced last month that the key ingredient in the nation’s most popular cold and flu medicine didn’t work, it was a “vindication” for the two scientists who spent nearly two decades trying to prove it was a dud .
Randy Hatton and Leslie Hendeles have been warning since the 1990s that phenylephrine – contained in Sudafed PE or Dayquil Cold and Flu – is as ineffective as a placebo pill that did not enter the bloodstream when taken and ended up in the nose.
Dr. Hendeles, an expert in 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 in Sudafed.
But despite all their findings since the first report in 1993 suggesting it’s ineffective, the FDA and consumer groups have continued to address their concerns and insist the ingredient is worth keeping on shelves .
It also made drug makers happy, as the phenylephrine drug made a profit of nearly $2 billion last year.
Dr. Leslie Hendeles [shown left] and dr. Randy Hatton [right] pushed the FDA to crack down on ineffective phenylephrine for nearly two decades before the agency concluded last month that the ingredient was no better than a placebo
The FDA panel’s unanimous vote that phenylephrine is ineffective is not binding, but it strongly suggests that the agency may soon heed its advice and revoke its approval, which could force companies to withdraw or discontinue their products.
The FDA’s announcement on September 12 that its advisory committee had concluded that phenylephrine is not effective as an oral decongestant (the nasal spray is still considered highly effective) surprised millions of Americans.
This included Hatton and Hendeles, both pharmacy professors 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 staff and advisory committee unanimously agreed on what we’ve been saying for a very long time.” is therefore definitely worth it.”
CVS has decided to discontinue certain cough and cold medications whose main ingredient is phenylephrine.
Dr. Hendeles said, “It was exciting for me to hear that.”
Since the FDA finds that some cold medicines don’t work, doctors tell them what to take instead
The US FDA has revealed that an ingredient in cold medicine doesn’t actually work, but it turns out grandma may have been right all along: chicken soup is the perfect cure.
However, other major chains such as Walgreens and RiteAid told DailyMail.com that they would only remove products from their shelves if the FDA required 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 is intended to narrow blood vessels to relieve blockage.
By 2006, the cold medicine Sudafed was the go-to treatment for colds and sinus problems for millions of Americans.
The key ingredient, pseudoephedrine, is a highly sought-after chemical precursor in secret labs that manufacture methamphetamine, a fact many may not have known until Breaking Bad character Jesse Pinkman showed up in Americans’ living rooms.
But many experts knew this, including Dr. Hendeles, who had already discovered that phenylephrine in pill form is rapidly absorbed and excreted in the intestines before it can have any effect, rendering it virtually worthless.
In comparison, pseudoephedrine is barely metabolized and 90 percent enters the bloodstream and is transported via the blood to the nose.
Now that pseudoephedrine has moved to the back of the pharmacy behind the counter, most cough and cold medicine manufacturers have replaced amphetamine with phenylephrine.
At that time, Dr. Hatton established a pharmaceutical research lab at UF where students answered questions from medical professionals about specific medications and worked to find answers.
Suddenly, they received a flood of calls from pharmacists telling them that customers complained that their cold medicine was not working.
The research of dr. Hatton’s laboratory led them to the research of dr. Hendeles in 1993. As their offices were across the hall from each other, it wasn’t long before the two could work together.
They collected all the studies they could find on phenylephrine, evaluated them all, and concluded in 2007 that the standard dose of 10 milligrams was no more effective than a sugar pill.
CVS will begin removing popular cough and cold products that contain phenylephrine as the only active ingredient from shelves. Pictured: Empty CVS shelves in New York City
The drugstore chain is voluntarily removing the products after a panel of FDA advisors last month refused to support the effectiveness of oral, over-the-counter medications containing the ingredient
They wrote a petition to the FDA asking them to increase the standard dose to 25 mg and revoke approval for use of the drug in children under 12. They did not call on the FDA to remove the drug from shelves.
An FDA hearing to discuss the issue included testimony from representatives of Schering Plow (now Merck), which at the time made the wildly 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 equally ineffective, not only at 10 mg, but at a dose four times higher. Only one percent of the drug was active in the bloodstream.
DR Hatton and Hendeles took those findings and wrote another petition to the FDA in 2015, which led to the agency’s Nonprescription Drug Advisory Committee unanimously agreeing that the ingredient doesn’t work, ending roughly two decades of indicate. by Dr. Hatton and Hendeles are completed. ‘ hard work.
Dr. Hendeles said: “This is a big lesson for people and they should ask their pharmacist before buying a product.” So this is one thing that the pharmaceutical companies are learning: They have to answer the question: Why are they selling something, which you know is not effective?
Their ruling is not binding, but it strongly suggests that the agency may soon follow their advice and withdraw approval, forcing companies to withdraw or reformulate their products.
The ingredient is protected by the FDA’s GRASE (Generally Recognized as Safe and Effective) designation, but a withdrawal of the approval could require manufacturers such as Bayer, Johnson and Johnson to reformulate the formula.
If you have a cold and stuffy nose, you should probably drink a bowl of chicken soup for now rather than a pack of Tylenol Cold & Flu.
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Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
