An advisory committee to the U.S. Food and Drug Administration determined Tuesday that an ingredient in common cold medications isn’t effective, raising the possibility that popular decongestants could be removed from the shelves of U.S. stores.
The ingredient, phenylephrine, has been in use for decades and is in dozens of medications, including versions of Sudafed and Tylenol. The FDA estimates that consumers last year bought more than 240 million bottles or packages of over-the-counter products containing phenylephrine, at a cost of about $1.76 billion, according to an agency briefing document.
The FDA had affirmed the efficacy of phenylephrine as recently as 2007. But an agency review of more recent studies led its staff to conclude that the ingredient isn’t effective as a nasal decongestant when taken orally, a position FDA acknowledged was a “major change.” It didn’t identify any safety concerns.
The FDA sought the input of an advisory committee, which agreed unanimously with the agency’s about-face on phenylephrine’s effectiveness.
“We do not believe as a panel that the current scientific data support” a dosage of oral phenylephrine “as effective as a nasal decongestant,” Maria Coyle, a professor at the Ohio State University College of Pharmacy and chair of the FDA’s nonprescription drug committee, said at its meeting Tuesday. The committee’s recommendation isn’t binding.
If the FDA revoked phenylephrine’s status as a safe and effective ingredient, that could mean over-the-counter products containing it would no longer be sold in U.S. stores.
An FDA representative said the agency would consider the committee’s determination, along with comments from the public and industry. An agency spokesperson didn’t respond to a request for comment.
The Consumer Healthcare Products Association, an industry trade group, criticized the committee’s recommendation, calling it “at odds with numerous clinical trials and previous regulatory determinations” and warning of “unintended consequences” of changing its regulatory status.
Phenylephrine works by temporarily constricting blood vessels. It is one of two oral nasal decongestants available to consumers along with pseudoephedrine, a so-called “behind-the-counter” product that faces restrictions on its sale under federal law because of its potential to be used to make methamphetamine. Those restrictions, in part, have led drug companies to reformulate products to instead include phenylephrine, according to the FDA.
Behind the FDA’s shift is data from three clinical trials that were conducted after it last evaluated phenylephrine. The agency called the studies “by far the largest and most carefully constructed trials that have ever been performed” to evaluate the ingredient as a decongestant. None of them demonstrated a significant difference compared with placebos, the FDA wrote in a briefing report. At the same time, it cast doubt on the quality of studies it had previously relied on to determine phenylephrine’s effectiveness.
In the FDA’s review, it projected that the consequences of removing phenylephrine products would be far-reaching.
“A significant impact on industry is inevitable,” the agency said, adding there will be “significant retooling costs.” For consumers, it might help them avoid “unnecessary costs of taking a drug with no benefit.” Still, the agency pointed to the possibility that some might not appreciate finding their preferred cold medication is no longer available.
“Some consumers may believe that [oral phenylephrine] is helpful to them, resulting in frustration and anger if it is no longer available to purchase,” the agency wrote.
Source: Matzav/(c) 2023, The Washington Post · Daniel Gilbert
