Popular decongestants don’t work. The FDA is finally doing something about it
In a long-sought moveThe U.S. Food and Drug Administration on Thursday officially began the process of waiving oral doses of a common over-the-counter decongestant that the agency concluded last year was ineffective in relieving nasal congestion.
Specifically, the FDA has issued a proposed order removes oral phenylephrine from the list of drugs that drug manufacturers can include in over-the-counter products—also known as OTC monographs. Once phased out, drug manufacturers will no longer be able to include phenylephrine in products to temporarily relieve nasal congestion.
“The FDA’s role is to ensure that drugs are safe and effective,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Based on a review of available data and consistent with the advisory committee’s advice, we are taking the next step in the proposed process to eliminate oral phenylephrine because it is not as effective as decongestants. ”
For now, the order is just a proposal. The FDA will open a public comment period, and if there are no comments that would affect the FDA’s previous conclusion that the drug is useless, the agency will issue a final order. Drug manufacturers will have a grace period to improve their products.
Review reviews
Gradually weaning off phenylephrine takes many years to accomplish. The decongestant was originally approved by the FDA in 1976, but it gained popularity after the “Methamphetamine Epidemic Act of 2005” went into effect and pseudoephedrine—the main ingredient in Sudafed—was moved behind the counter. to prevent use. to produce methamphetamine. With pseudoephedrine not easily available in pharmacies, phenylephrine has become the leading over-the-counter decongestant. And researchers had questions.
In 2007, an FDA panel re-evaluated the drug, which is believed to work by shrinking blood vessels in the nasal passages, opening the airways. Although the panel upheld the drug’s approval, it concluded that more research is needed for a full evaluation. Three large, carefully designed studies were then conducted—two by Merck on the treatment of seasonal allergies and one by Johnson & Johnson on the treatment of the common cold. All three found no significant difference between phenylephrine and placebo.
Last year, The FDA has re-evaluated the drug againexamines new studies and takes a deeper look at 14 studies from the 1950s to 1970s that led to phenylephrine’s initial approval. The FDA noted that those 14 studies assessed obstruction using a questionable measure of nasal airway resistance and were abandoned. But even with poor quality measurements, the studies yielded mixed efficacy results. And the general finding of effectiveness is based on just two studies performed at the same laboratory.
Too good to be true
No other laboratory has been able to replicate the positive results from those two studies. And when FDA scientists carefully looked at the data, they found evidence that some of the numbers may have been falsified and that the results were “too good to be true.”
As the final nail in phenylephrine’s coffin, modern studies show that when phenylephrine is taken orally, it is extensively metabolized in the intestines, leaving less than 1% of the consumed dose active in the body. . This finding explains why oral doses do not cause constriction of blood vessels throughout the body, which can lead to increased blood pressure – a side effect that sometimes occurs with pseudoephedrine. Although researchers initially thought the lack of increase in blood pressure was a positive finding, in retrospect, it was a sign that the drug wasn’t working.
At the same time, an FDA advisory group voted unanimously, 16 to 0, that oral doses of phenylephrine were not effective in treating nasal congestion. Then, CVS announced that they would Eliminate products with phenylephrine as the sole active ingredient.
Despite the seemingly damning evidence, the industry group representing manufacturers of products containing phenylephrine—the Consumer Healthcare Products Association (CHPA)—remains opposed to the FDA’s move.
“CHPA is disappointed in the FDA’s proposal to reverse its long-standing position on oral PE [phenylephrine],” CHPA Executive Director Scott Melville said in a statement Thursday. CHPA maintains its position on the drug’s effectiveness. “As science and methods advance, new data need to be considered in the context of the full range of available evidence, not as a complete replacement for previous evidence — especially when viewed Consider a widely used and safe ingredient like PE. CHPA will review the proposed Order and provide appropriate comments,” Melville said.
This story originally appeared on Ars Technica.
