In a long sought after movementThe U.S. Food and Drug Administration on Thursday officially began the process of discontinuing oral doses of a common over-the-counter decongestant that the agency concluded last year was not effective in relieving blocked nose.
Specifically, the FDA has issued an order proposal to remove oral phenylephrine from the list of drugs that drug manufacturers can include in over-the-counter products, also known as an OTC monograph. Once removed, drug manufacturers will no longer be able to include phenylephrine in products intended 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 available data and consistent with the advice of the advisory committee, we are taking the next step in the process to propose 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 public comment period, and if no comments can influence the FDA’s previous conclusion that the drug is unnecessary, the agency will make the order final. Drugmakers will be given a grace period to reformulate their products.
Revised reviews
Slowly coming off phenylephrine takes years. The decongestant was initially approved by the FDA in 1976, but rose to prominence after the “Methamphetamine Epidemic Act of 2005” and pseudoephedrine, the main component of Sudafed, took effect. ‘is moved behind the pharmacy counter to prevent it from being used. to make methamphetamine. With pseudoephedrine beyond the reach of pharmacies, phenylephrine has become the primary over-the-counter decongestant. And the researchers asked themselves questions.
In 2007, an FDA panel reevaluated the drug, which is believed to work by narrowing blood vessels in the nasal passages, thereby opening the airways. Although the committee confirmed approval of the drug, it concluded that additional 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 difference between phenylephrine and a placebo.
Last year, the FDA re-evaluated the drug againtaking into consideration new studies and taking a deeper look at the 14 studies from the 1950s to the 1970s that gave phenylephrine its initial approval. The FDA noted that these 14 studies assessed congestion using a questionable measure of nasal airway resistance that has since been abandoned. But even with poor-quality measures, studies have provided mixed effectiveness results. And the overall effectiveness finding was based on just two of the studies, which were conducted in the same laboratory.
Too good to be real
No other laboratory has ever been able to reproduce the positive results of these two studies. And when FDA scientists looked closely at the data, they discovered that some numbers might have been fudged and that the results were “too good to be real.”
As the final nail in the coffin of phenylephrine, modern studies suggest that when phenylephrine is taken orally, it is heavily metabolized in the intestine, leaving less than 1 percent of the consumed dose as active in the body. . This 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 increase in blood pressure was a positive result, in retrospect it suggested the drug was not effective.
With that, a panel of FDA advisors voted unanimously, 16 to 0, that oral doses of phenylephrine are not effective in treating a stuffy nose. Subsequently, CVS announced that it remove products containing phenylephrine as the sole active ingredient.
Despite the seemingly overwhelming evidence, the industry group representing manufacturers of phenylephrine products – the Consumer Healthcare Products Association (CHPA) – has consistently challenged the FDA’s decision.
“CHPA is disappointed by the FDA’s proposal to reverse its long-held view of oral PE (phenylephrine),” CHPA CEO Scott Melville said in a statement Thursday. The ACHP maintains its position on the effectiveness of the drug. “As science and methods advance, new data should be considered in the context of the available body of evidence, and not as a complete replacement of the previous body of evidence, particularly when considering an ingredient as safe and widely used as EP. CHPA will review the proposed ordinance and submit comments accordingly,” Melville said.
This story was originally published on Ars Technica.
