After spending many years on pharmacy cabinets, the main nasal decongestant in over-the-counter cold and allergy medicines has met its downfall.
Advisers for the Food and Drug Administration this week voted unanimously, 16 to 0, that oral doses of phenylephrine—present in brand-name merchandise like Sudafed PE, Benadryl Allergy Plus Congestion, Mucinex Sinus-Max, and Nyquil Severe Cold & Flu—are usually not efficient at treating a stuffy nostril.
The vote was years within the making. In 2007, amid doubts, FDA advisers referred to as for extra research. With the info that has trickled in since then, the company’s scientists carried out a cautious evaluation and got here to the agency conclusion that oral phenylephrine “is just not efficient as a nasal decongestant.”
Looking again, the FDA famous that key information supporting its authentic acceptance of phenylephrine in 1976 was probably “too good to be actual.” And trying ahead, the company noticed a bleak future for the drug. While this week’s vote concluding ineffectiveness applies solely to the oral dosages presently accredited to be used, the FDA discovered that larger, probably simpler doses of the drug may considerably enhance blood stress, posing a security danger. “[T]right here could also be no path to evaluating larger doses,” the company concluded.
To be clear, the advisers didn’t talk about phenylephrine-containing nasal sprays, which seem to have some efficacy. And, most significantly, the security of phenylephrine-containing merchandise is just not in query; the FDA and its advisers didn’t elevate any security issues. It’s protected, simply useless.
Rise and fall
It’s nonetheless unclear how the FDA will proceed following the advisory panel’s vote, which it isn’t obligated to heed however often does. But it is actually doable that extensively used phenylephrine-containing medicines may finally disappear from drug retailer aisles.
In a clarifying assertion Thursday, the FDA famous there is not going to be a swift blowout of the favored decongestant. If the company acts on the advisers’ votes and decides to wipe it off its checklist of efficient over-the-counter medicine (the “OTC monograph”), the company would first must suggest the elimination from the monograph, then present a public remark interval, situation a remaining ruling, and work with producers to reformulate merchandise.
Still, nonetheless gradual the method, if the FDA strips phenylephrine from the monograph, it is going to undoubtedly upend the over-the-counter cold and allergy medicine market. Popularity of phenylephrine skyrocketed after 2006, when its main competitors moved behind the pharmacy counter. The “Combat Methamphetamine Epidemic Act of 2005” went into impact that yr, limiting gross sales of the simpler drug pseudoephedrine, which might be diverted to creating methamphetamine. As pseudoephedrine use dropped, phenylephrine’s rose. By 2022, the FDA estimates that Americans purchased 242 million phenylephrine-containing merchandise, taking the lion’s share of the decongestant market and producing almost $1.8 billion in gross sales.
Given phenylephrine’s overwhelming market success and full scientific failure, it is price revisiting how we acquired right here—and the FDA gives a deep dive on simply that. The company notes that the unique 1976 acceptance of phenylephrine was primarily based on simply 14 research—solely 12 of which included efficacy information, and of these, solely seven reported some degree of constructive efficacy information (although most had been weakly constructive). Eleven of the 14 research had been sponsored by a drug maker. Last, all of the research used a doubtful measure of nasal airway resistance to evaluate results on congestion. This is a extremely variable, unvalidated technique that’s not accepted by the FDA in scientific trials.