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Saturday, May 18, 2024

What Delayed the FDA’s Action on a Controversial Cold Remedy

Dr. Leslie Hendeles, back when he had a mane of curly red hair and Bill Clinton had just taken office, first started pushing the Food and Drug Administration to reject a decongestant in cold treatments.

At age 80, with white hair and a 50-year perspective on the component, Dr. Hendeles appeared as an expert to speak before the agency’s advisors when opposition to the medicine finally crystallised.

Tuesday’s unanimous decision by the advisory group to declare the decongestant, a popular component in cold and flu medicines, useless was the result of his campaigning.

After reading the news, many people rushed to their medicine cabinets to find the decongestant phenylephrine, which was found in more than 250 medications. These included popular brands like DayQuil, Sudafed, Tylenol, and Theraflu. The decision has led to some ambiguity, since specialists maintain that the active component is effective in nasal sprays but not in tablet or liquid form.

Nothing will happen right now. Instead of immediately removing so many commonly used products off shop shelves, F.D.A. authorities must first study the panel’s findings, seek public opinions, and likely allow medication manufacturers some time to alter or change out chemicals. If the corporations decide to challenge the proceedings in court, it might cause more delays. And other specialists, like former FDA commissioner Dr. Scott Gottlieb, have insisted for a long time that phenylephrine does work. There may be others who attempt to fight any effort to completely outlaw the decongestant.

It’s a complicated tale, combining archaic drug standards going back to a statute signed by President Kennedy, the rise of meth laboratories employing common cold medications in the 1990s, and even the pandemic, that explains how phenylephrine survived on the market this long despite decades of investigations and doubts.

Although the FDA had control over two more popular decongestants that were successful and a third that was not, phenylephrine, Dr. Hendeles wrote his first criticism of the medicine in 1993. The medication’s intended effects were vasoconstriction and alleviation of nasal congestion. However, he reported in a medical publication that it was destroyed in the stomach. Because of this, very little of the drug entered the circulation and even less reached the nasal passages.

Dr. Hendeles, who had previously worked as a visiting scientist at the F.D.A., attempted to get in touch with them as their investigation advanced. He said he was not making any headway. So he contacted the office of California’s crusading U.S. Representative Henry Waxman.

Dr. Hendeles remembered what he regarded to be the most compelling evidence presented. Schering Plough, the manufacturer of Claritin-D at the time, claimed to its advisors that they had researched the effectiveness of phenylephrine, an alternative decongestant, and found it to be ineffective. Mr. Waxman said that the company’s newspaper advertising bragged about their “bold move” to maintain the “powerful formula” for Claritin-D.

Dr. Gottlieb, who served as commissioner of the FDA from 2017 until early 2019, criticised the panel’s decision in a series of tweets sent after this week’s vote, calling it “a shame.”When they first investigated this subject in 2005/2006, phenylephrine “was believed to be weakly active,” he said. Consumers may now be left with no effective, low-cost, easily available solutions for temporary relief.

The National Centre for Health Research, the American College of Clinical Pharmacy, and Public Citizen all wrote to the panel requesting that they remove the chemical from consideration. The trade group contended that the active component was effective even at low blood concentrations. Kenvue, a spinoff of Johnson & Johnson, issued a statement in which it claimed that sales of cold remedies containing phenylephrine were a negligible portion of overall sales.

There have already been lawsuits announced on behalf of consumers who bought phenylephrine-containing cold and flu remedies, alleging that the drug’s manufacturers knew the decongestant was ineffective.

Jonathan James
Jonathan James
I serve as a Senior Executive Journalist of The National Era
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