In a long-sought moveThe U.S. Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant that the agency concluded last year is not effective in relieving nasal congestion.
Specifically, the FDA issued a proposed order remove oral phenylephrine from the list of medications that drug manufacturers can include in over-the-counter products, also known as OTC monographs. Once removed, drug manufacturers will no longer be able to include phenylephrine in products for the temporary relief of 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 our review of the available data and in accordance with the advice of the advisory committee, we are taking the next step in the process to propose the elimination of oral phenylephrine because it is not effective as a nasal decongestant.”
For now, the request is just a proposal. The FDA will open a public comment period, and if no comments can influence the FDA’s previous conclusion that the drug is useless, the agency will make the order final. Drug manufacturers will have a grace period to reformulate their products.
Reviews reviewed
The slow weaning of phenylephrine has been years in the making. The decongestant was originally approved by the FDA in 1976, but rose to prominence after the “Combating the Methamphetamine Epidemic Act of 2005” went into effect, and pseudoephedrine, the main ingredient in Sudafed, was placed behind the pharmacy counter to prevent it from being used. to produce methamphetamine. As pseudoephedrine was out of easy access in pharmacies, phenylephrine became the leading over-the-counter decongestant. And the researchers had questions.
In 2007, an FDA panel reevaluated the drug, which supposedly works by narrowing blood vessels in the nasal passage, opening the airways. While the panel confirmed the drug’s approval, it concluded that more studies were needed for a full evaluation. After that, three large, carefully designed studies were conducted: two by Merck for the treatment of seasonal allergies and one by Johnson & Johnson for the treatment of the common cold. All three found no significant differences between phenylephrine and placebo.
Last year, the FDA reevaluated the drug againtaking into account the new studies and delving into the 14 studies carried out between the years 1950 and 1970 that earned phenylephrine its initial approval. The FDA noted that those 14 studies assessed congestion using a dubious measure of nasal airway resistance that has since been abandoned. But even with poor-quality measurements, the studies provided mixed effectiveness results. And the overall efficacy finding depended on just two of the studies, which were conducted in the same laboratory.
Too good to be true
No other laboratory was able to replicate the positive results of those two studies. And when FDA scientists carefully examined the data, they found evidence that some of the numbers may have been manipulated and that the results were “too good to be true.”
As the final nail in phenylephrine’s coffin, modern studies suggest that when phenylephrine is taken orally, it is highly metabolized in the intestine, leaving less than 1 percent of the consumed dose active in the body. The finding explains why oral doses do not cause constriction of blood vessels throughout the body, which could lead to increased blood pressure, a side effect sometimes seen with pseudoephedrine. While researchers initially thought the lack of increases in blood pressure was a positive finding, in retrospect, it was an indication that the medication was not working.
With that, an FDA advisory panel voted unanimously, 16 to 0, that oral doses of phenylephrine are not effective in treating nasal congestion. CVS later announced that eliminate products that had phenylephrine as the only active ingredient.
Despite the seemingly damning evidence, the industry group representing manufacturers of products containing phenylephrine, the Consumer Healthcare Products Association (CHPA), still questioned the FDA’s action.
“The CHPA is disappointed by the FDA’s proposal to reverse its long-established view on oral PE (phenylephrine),” CHPA Executive Director Scott Melville said in a statement on Thursday. The CHPA maintains its position on the drug’s effectiveness. “As science and methods advance, new data should be considered in the context of all available evidence, not as a complete replacement of the previous body of evidence, especially when considering an ingredient as safe and widely used as PE. . “The CHPA will review the proposed order and submit comments accordingly,” Melville said.
This story originally appeared on Ars Technique.
