The Food and Drug Administration announced Wednesday that it would seek to pull a widely used ingredient in cough and cold medicines from the market, after the agency’s scientists concluded that the oral version of the drug is ineffective as a nasal decongestant.
The FDA’s proposal comes more than a year after the agency’s outside advisers voted against continued use of the ingredient, called oral phenylephrine, citing concerns with the initial data used to support its approval and new data questioning its effectiveness.
A number of common over-the-counter nasal decongestants have relied on phenylephrine alone or in combination with other ingredients for years, including some cold and cough versions of Advil, NyQuil, Sudafed, Robitussin, Tylenol and Theraflu.
“Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release.
The agency’s proposed order would remove oral phenylephrine from the “monograph” of ingredients that drugmakers are allowed to use in cough and cold medicines which are sold on store shelves without a prescription.
The public has until May 7 next year to weigh in on the proposal. After that comment period, if the FDA decides to finalize its proposal to revoke oral phenylephrine’s status as “generally recognized as safe and effective,” over-the-counter drugmakers would be forced to stop using the ingredient.
“The FDA would provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market,” the agency said in its release.
The Consumer Healthcare Products Association said Thursday it was “disappointed” in the FDA’s proposal. The industry trade group renewed its claim that no changes “are warranted” for oral phenylephrine and cited previous FDA and advisory committee decisions that did not call for pulling the ingredient.
“PE should remain an available option for consumers, because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on,” Scott Melville, CHPA’s president and CEO, said in a statement.
After the FDA’s advisory committee last year, pharmacy chain CVS said it would pull any products on its shelves that only contained the product.
Spokespeople for drugmakers behind the brands did not immediately respond to requests for comment.
The FDA’s proposal caps a push by pharmacy professors at the University of Florida who have urged the agency for years to pull the product, pointing to new data showing phenylephrine did no better than a placebo when swallowed.
The latest data shows that only a tiny fraction of phenylephrine is absorbed into the body when digested from a pill or syrup containing phenylephrine. This is different from other formulations like the inhaled nasal spray versions of the drug, where larger percentages of the drug can make it into the bloodstream.
The researchers also have questioned the initial studies that were run to prove the drug’s effectiveness, though they acknowledge that it is safe at currently approved levels.
“Let me be clear, oral phenylephrine is not a safety risk,” Hatton, a professor at the University of Florida, told CBS News last year. “It just doesn’t work.”
In a scientific review published this week by the FDA, the agency’s scientists concluded that past studies estimating that higher percentages of the drug could be absorbed during digestion were “an overestimate and based on outdated technology.
Less than 1% of the drug is absorbed into the bloodstream after being swallowed, they estimated. Far higher doses could “be needed to achieve a clinically meaningful outcome which would raise significant questions about safety.”
“Furthermore, there are no clinical data demonstrating that oral PE is effective as a nasal decongestant at any dosage,” the FDA’s scientists wrote.
