In a long-awaited moveThe U.S. Food and Drug Administration on Thursday formally began the process of phasing out oral doses of a common over-the-counter decongestant that the agency concluded last year was effective in relieving nasal congestion. Not there.
Specifically, the FDA issued a proposed order To remove oral phenylephrine from the list of drugs 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 temporary relief of nasal congestion.
“It is the FDA's role 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 consistent with the advisory committee's advice, we are taking the next step in the process to propose removing oral phenylephrine because it is not as effective as a nasal decongestant.”
At present this order is just a proposal. The FDA will open a public comment period, and if no comments can affect the FDA's previous conclusion that the drug is worthless, the agency will make the order final. Drug manufacturers will get time to reformulate their products.
Reviewed Reviews
The slow abandonment of phenylephrine has been going on for years. The decongestant was originally approved by the FDA in 1976, but came to prominence after the “Combat Methamphetamine Epidemic Act of 2005” went into effect, and pseudoephedrine – the main ingredient of Sudafed – was banned from pharmacy counters to prevent it from being used. Went after. To make methamphetamine. As pseudoephedrine became out of easy access at drugstores, phenylephrine became the leading over-the-counter decongestant. And researchers had questions.
In 2007, an FDA panel re-evaluated the drug, which reportedly works to open up airways by shrinking blood vessels in the nasal passages. While the panel upheld the drug's approval, it concluded that more studies were needed for 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, FDA re-evaluates the drugTaking into account the new studies and taking an in-depth look at the 14 studies from the 1950s to the 1970s that gave phenylephrine its initial approval. The FDA noted that 14 of those studies assessed congestion using a questionable measurement of nasal airway resistance that has since been abandoned. But even with poor measurements, studies provided mixed efficacy results. And the overall conclusion of efficacy depended on only two studies, which were conducted in the same laboratory.
too good to be real
No other laboratory was able to replicate the positive results of those two studies. And when FDA scientists looked carefully at the data, they found evidence that some of the numbers could have been manipulated and that the results were “too good to be true.”
As the final nail in the coffin of phenylephrine, modern studies show 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. Is. The finding explains why oral doses do not cause the constriction of blood vessels throughout the body that can lead to an increase in blood pressure – a side effect sometimes seen with pseudoephedrine. While researchers initially thought the lack of increase in blood pressure was a positive finding, in retrospect, it was a sign that the drug was not working.
Additionally, a panel of advisors to the FDA voted unanimously 16 versus 0 that oral doses of phenylephrine are not effective in treating nasal congestion. Later, CVS announced that it would Eliminate products in which phenylephrine was the only active ingredient,
Despite the seemingly damning evidence, the industry group representing manufacturers of phenylephrine-containing products – the Consumer Healthcare Products Association (CHPA) – still disputed the FDA's move.
“CHPA is disappointed by FDA's proposal to reverse its long-established position regarding oral PE [phenylephrine]” said Scott Melville, CEO of CHPA. a statement on ThursdayThe CHPA maintains its position on the efficacy of the drug. “As science and methods advance, new data should be considered in the context of the full weight of available evidence, not as a complete replacement of the previous body of evidence – particularly when a component is identified as a PE. Safe and widely used. CHPA will review the proposed order and submit comments accordingly,” Melville said.
This story was originally published on Ars Technica,