In a long-sought move, the US Food and Drug Administration on Thursday formally began the process of phasing out oral doses of a common decongestant that the agency ruled last year was ineffective at relieving nasal congestion.
Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter products—also known as the OTC monograph. Once withdrawn, drug makers will no longer be able to include phenylephrine in products for temporary relief of nasal congestion.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 advice of the advisory committee, we are taking this next step in the process to recommend removing oral phenylephrine because it is not effective as a nasal decongestant.”
For now, the order is just a suggestion. The FDA will open a period for public comment, and if there are no comments that would change the FDA’s previous conclusion that the drug is ineffective, the agency will make the order final. Drug makers will have a good time to reinvent their products.
Updated Reviews
The gradual elimination of phenylephrine develops over the years. The decongestant was first approved by the FDA in 1976, but came into the limelight after the “Anti-Congestive Drug Act of 2005” went into effect, and pseudoephedrine—the main component of Sudafed—moved from behind the pharmacy counter to keep it from being used. making methamphetamine. Since pseudoephedrine is not easily accessible in drug stores, phenylephrine has been the best over the counter combination. And the researchers had questions.
In 2007, an FDA panel re-evaluated the drug, which is said to work by narrowing the blood vessels in the nasal passages, opening up the airways. While the panel recommended approval of the drug, it concluded that more research was needed to fully evaluate it. After that, three large, carefully designed studies were conducted—two by Merck to treat seasonal allergies and one by Johnson & Johnson to treat the common cold. All three found no significant difference between phenylephrine and placebo.
Last year, the FDA re-evaluated the drug again, taking into account new studies and taking a closer look at 14 studies from the 1950s to 1970s that got phenylephrine its first approval. The FDA noted that 14 of those studies assessed congestion using a questionable measure of nasal airway resistance that has been discontinued. But even on a perfect scale, studies have provided mixed results on effectiveness. And the overall finding of effectiveness was based on only two studies, which were conducted in the same lab.
Too Good To Be True
No other lab has been able to replicate the positive results from those two studies. And when FDA scientists looked at the data carefully, they found evidence that some of the numbers may have been true and that the results were “too good to be true.”
As the final nail in the coffin of phenylephrine, modern research suggests that when phenylephrine is taken orally, it is largely metabolized in the intestines, leaving less than 1 percent of the dose used to work in the body. The findings explain why oral doses do not cause the constriction of blood vessels throughout the body that can lead to increased blood pressure—a side effect sometimes seen with pseudoephedrine. Although the researchers initially thought that the increase in blood pressure was a positive effect, in retrospect, it was an indication that the drug was not working.
With that, an FDA advisory panel voted unanimously, 16 to 0, that oral doses of phenylephrine are ineffective in treating nasal congestion. After that, CVS announced that it would remove products with phenylephrine as the only active ingredient.
Despite the overwhelming evidence, the industry group that represents manufacturers of phenylephrine-containing products—the Consumer Healthcare Products Association (CHPA)—still opposes the FDA’s move.
“CHPA is disappointed by the FDA’s proposal to reverse its long-standing opinion on oral PE. [phenylephrine],” said CHPA chief Scott Melville in a statement Thursday. CHPA maintains its position on the effectiveness of the drug. of previous evidence—especially when considering an ingredient that is used safely and widely as CHPA will review the Proposed Order and submit comments accordingly,” Melville said.
This story appeared first Ars Technica.
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