A Popular Decongestant Doesn’t Work. The FDA Is Finally Doing Something About It

In a long-sought move, the US Food and Drug Administration connected Thursday formally began the process of abandoning oral doses of a communal over-the-counter decongestant that the bureau concluded past twelvemonth is not effectual astatine relieving stuffy noses.

Specifically, the FDA issued a projected order to region oral phenylephrine from the database of drugs that drugmakers tin see successful over-the-counter products—also known arsenic the OTC monograph. Once removed, drugmakers volition nary longer beryllium capable to see phenylephrine successful products for the impermanent alleviation of nasal congestion.

"It is the FDA’s relation to guarantee that drugs are harmless and effective," Patrizia Cavazzoni, manager of the FDA’s Center for Drug Evaluation and Research, said successful a statement. “Based connected our reappraisal of disposable information and accordant with the proposal of the advisory committee, we are taking this adjacent measurement successful the process to suggest removing oral phenylephrine due to the fact that it is not effectual arsenic a nasal decongestant.”

For now, the bid is conscionable a proposal. The FDA volition unfastened up a nationalist remark period, and if nary comments tin sway the FDA's erstwhile decision that the cause is useless, the bureau volition marque the bid final. Drugmakers volition get a grace play to reformulate their products.

Reviewed Reviews

The slow-moving abandonment of phenylephrine is years successful the making. The decongestant was primitively approved by the FDA successful 1976, but it came to prominence aft the “Combat Methamphetamine Epidemic Act of 2005” came into effect, and pseudoephedrine—the main constituent of Sudafed—moved down the pharmacy antagonistic to support it from being utilized to marque methamphetamine. With pseudoephedrine retired of casual scope astatine drugstores, phenylephrine became the starring over-the-counter decongestant. And researchers had questions.

In 2007, an FDA sheet reevaluated the drug, which supposedly works by shrinking humor vessels successful the nasal passage, opening up the airway. While the sheet upheld the drug's approval, it concluded that much studies were needed for a afloat assessment. After that, 3 large, cautiously designed studies were conducted—two by Merck for the attraction of seasonal allergies and 1 by Johnson & Johnson for the attraction of the communal cold. All 3 recovered nary important quality betwixt phenylephrine and a placebo.

Last year, the FDA reevaluated the cause again, taking into information the caller studies and taking a deeper look astatine the 14 studies from the 1950s to 1970s that earned phenylephrine its archetypal approval. The FDA noted that those 14 studies assessed congestion utilizing a dubious measurement of nasal airway absorption that has since been abandoned. But adjacent with the shoddy measurement, the studies provided mixed efficacy results. And the wide uncovering of efficacy hinged connected lone 2 of the studies, which were conducted astatine the aforesaid lab.

Too Good to Be Real

No different laboratory was ever capable to replicate the affirmative results from those 2 studies. And erstwhile FDA scientists cautiously looked done the data, they recovered grounds that immoderate of the numbers could person been fudged and that the results were “too bully to beryllium real.”

As a last nail successful phenylephrine's coffin, modern studies suggest that erstwhile phenylephrine is taken orally, it's highly metabolized successful the gut, leaving little than 1 percent of the consumed dose arsenic progressive successful the body. The uncovering explains wherefore oral doses don't origin the constriction of humor vessels passim the assemblage that could pb to an uptick successful humor pressure—a broadside effect sometimes seen with pseudoephedrine. While researchers initially thought the deficiency of humor unit increases was a affirmative finding, successful retrospect, it was a hint that the cause wasn't working.

With that, a sheet of advisers for the FDA voted unanimously, 16 to 0, that oral doses of phenylephrine are not effectual astatine treating a stuffy nose. Afterward, CVS announced that it would remove products that had phenylephrine arsenic the sole progressive ingredient.

Despite the seemingly damning evidence, the manufacture radical representing makers of phenylephrine-containing products—the Consumer Healthcare Products Association (CHPA)—still disputed the FDA's move.

“CHPA is disappointed successful FDA’s connection to reverse its long-established presumption of oral PE [phenylephrine]," CHPA CEO Scott Melville said successful a connection Thursday. The CHPA maintains its presumption connected the drug's efficacy. “As subject and methods advance, caller information should beryllium considered successful the discourse of the afloat value of disposable evidence, not arsenic a implicit replacement of the erstwhile assemblage of evidence—especially erstwhile considering an constituent arsenic safely and wide utilized arsenic PE. CHPA volition reappraisal the Proposed Order and taxable comments accordingly," Melville said.

This communicative primitively appeared on Ars Technica.