With a long-awaited movethe U.S. Food and Drug Administration on Thursday formally began the process to discontinue oral administration of a common over-the-counter nasal decongestant that the agency concluded last year was ineffective at relieving nasal congestion.
Specifically, the F.D.A. proposed order Remove oral phenylephrine from the list of drugs that pharmaceutical companies can include in over-the-counter products (also known as OTC monographs). Once phenylephrine is removed, drug companies will no longer be able to include it in products intended to temporarily relieve nasal congestion.
“FDA’s role is to ensure that medicines 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 on the advice of our advisory committee, we are moving to the next step in the process proposing the removal of phenylephrine because oral phenylephrine is ineffective as a nasal obstructor.”
For now, this order is just a suggestion. The FDA will hold a public comment period, and if no comments change the agency’s previous conclusion that the drug is not helpful, the agency will finalize its order. Pharmaceutical companies will be given a grace period to reformulate their products.
Reviewed Reviews
The phase-out of phenylephrine has been slow and ongoing over many years. This nasal decongestant was originally approved by the FDA in 1976, but became famous after the Methamphetamine Epidemic Control Act of 2005 went into effect, requiring pharmacy counters to avoid the use of pseudoephedrine, the main ingredient in Sudafed. Moved to the back. To make methamphetamine. Because pseudoephedrine is not readily available in drug stores, phenylephrine has become the primary over-the-counter nasal decongestant. And researchers had doubts.
In 2007, an FDA panel re-evaluated the drug, which is said to constrict blood vessels in the nasal passages and widen the airways. The committee supported approval of the drug, but concluded that further research is needed for a full evaluation. Three large, carefully designed studies were then conducted. Two are from Merck & Co. for the treatment of seasonal allergies, and one is from Johnson & Johnson for the treatment of the common cold. No significant differences were found between phenylephrine and placebo for all three.
last year, FDA reevaluated the drug againconsiders new research and takes a closer look at the 14 studies from the 1950s to the 1970s that won phenylephrine’s initial approval. The FDA noted that these 14 studies used a questionable measure of nasal airway resistance to assess nasal congestion, but that measure is now obsolete. However, even with crude measurements, studies have yielded mixed efficacy results. And the overall efficacy finding relied on only two studies conducted in the same laboratory.
too good to be true
No other laboratory was able to replicate the positive results obtained in these two studies. And when FDA scientists looked closely at the data, they found evidence that some of the numbers may have been fabricated and that the results “do not seem real.”
As the final nail in phenylephrine’s coffin, modern research suggests that when phenylephrine is taken orally, it is highly metabolized in the intestines, with less than 1 percent of the ingested amount remaining active in the body. This finding explains why oral administration does not cause the constriction of blood vessels throughout the body, which can lead to increased blood pressure, a side effect sometimes seen with pseudoephedrine. The researchers initially thought the lack of an increase in blood pressure was a good finding, but in hindsight, it suggested the drug wasn’t working.
In response, the FDA’s advisory committee unanimously voted 16-0 to find that oral phenylephrine is not effective in treating nasal congestion. CVS then announced: Eliminate products that contain phenylephrine as the only active ingredient.
Despite the seemingly damning evidence, the Consumer Healthcare Products Association (CHPA), a trade group representing manufacturers of phenylephrine-containing products, still objected to the FDA’s move.
“CHPA is disappointed with FDA’s proposal to reverse its long-established position on oral PE.” [phenylephrine]” said CHPA CEO Scott Melville. Thursday’s statement. CHPA maintains its position on the effectiveness of this drug. “As science and methods advance, especially when considering an ingredient as safe and widely used as PE, new data should not be viewed as a complete replacement of previous bodies of evidence, but rather as an extension of the available evidence. The full weight needs to be considered. CHPA will consider the proposed order and submit comments accordingly,” Melville said.
This story was originally ars technica.
