FDA panel says ingredient in popular oral decongestants is not effective

The main ingredient in popular oral decongestants doesn’t seem to work, advisers to the Food and Drug Administration said Tuesday in a unanimous vote that could result in the products being withdrawn from store shelves.

The substance in question, phenylephrine, is found in Sudafed PE, Dayquil and Benadryl Allergy Plus Congestion and became the ingredient of choice in over-the-counter medicines after pseudoephedrine was moved behind the counter because of fears it can be processed into methamphetamine or meth.

The panel’s decision follows years of doubt about phenylephrine. As far back as 2007, a team from the University of Florida said the drug was unable to outperform placebos in cold-and-allergy studies.

“I think the evidence [is] pretty compelling that this medication is not effective and really can’t be effective,” Susan Blalock, a retired professor at the UNC Eshelman School of Pharmacy and adviser on the Nonprescription Drugs Advisory Committee, said Tuesday.

She was among 16 advisers who said trial data and pharmacokinetics, a branch of science that studies the movement of drugs in the body, brought them to a clear conclusion about the oral drugs.

“At this point, I think enough studies have been done. I don’t believe that additional trials would produce a different outcome. I feel that this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzrott, a patient representative who sits on the advisory panel.

Other advisers said it would be unfair and potentially dangerous to let patients continue to spend money on drugs that don’t work, especially if there are alternatives.

The FDA will decide whether to accept the panel’s recommendations. If regulators do, it could force consumers to pivot to pills sold behind counters or other forms of phenylephrine drugs, such as nasal sprays.

The Consumers Healthcare Products Association, a trade group that represents drugmakers, objected to the vote and said previous trials and regulatory determinations supported oral phenylephrine, or “PE,” as safe and effective.

“We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status,” CHPA President and CEO Scott Melville said. “While we respect the scientific and public process that allows new science to influence health policy and regulations, we are concerned about previous clinical evidence being inappropriately dismissed and discounted.”

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