The Food and Drug Administration is considering a change that could remove cold medications containing phenylephrine from the shelves of U.S. stores after finding it ineffective.
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., 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.
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