Common nasal decongestants are not effective. FDA finally took some action

In a long-awaited move, the U.S. Food and Drug Administration on Thursday formally began the process of discontinuing oral administration of a common over-the-counter nasal decongestant, which the agency announced last year was not effective in relieving nasal congestion. concluded.

Specifically, the FDA issued a proposed order to 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 FDA’s previous conclusion that the drug is of no use, 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. For all three, no significant differences were found between phenylephrine and placebo.

Last year, the FDA reevaluated the drug again, taking into account new research and taking a closer look at 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 subsequently announced that it would remove products containing 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 by FDA’s proposal to reverse its long-established position on oral PE (phenylephrine),” CHPA CEO Scott Melville said in a statement Thursday. CHPA maintains its position on the effectiveness of this drug. Data should be considered in the context of the totality of available evidence, rather than as a complete replacement for previous bodies of evidence. Especially when considering ingredients that are as safe and widely used as CHPA will consider the proposed order and submit comments accordingly. ” said Melville.

This story was originally Ars Technica.