The Food and Drug Administration announced Wednesday that it will try to remove widely used material of cough and cold medicines from the market after agency scientists concluded that the oral version of the drug was ineffective as a nasal decongestant.
The FDA's proposal comes more than a year after the agency's outside advisers voted against The continued use of an ingredient called oral phenylephrine, citing concerns with both the initial data used to support its approval and new data that questions its effectiveness.
Many common over-the-counter nasal decongestants have been relied upon phenylephrine For years it has been used alone or in combination with other ingredients, including Advil, Nyquil, Sudafed, Robitussin, Tylenol, and some cold and cough versions of Theraflu.
“Based on our review of the available data, and consistent with the advice of the advisory committee, we are taking the next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” said director Dr. Patrizia Cavazzoni of the FDA's Center for Drug Evaluation and Research said in a news release. release,
agency proposal Order Oral phenylephrine will be removed from the “monograph” of ingredients that drug manufacturers are allowed to use in cough and cold medicines sold on store shelves without a prescription.
The public has until May 7 next year to consider the proposal. Following that comment period, if the FDA decides to finalize its proposal to revoke oral phenylephrine's status of “generally recognized as safe and effective,” over-the-counter drug manufacturers would The component will be forced to stop being used.
“FDA will provide manufacturers a reasonable time to reformulate oral phenylephrine-containing drugs 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 “required” for oral phenylephrine and cited previous FDA and advisory committee decisions that did not call for removal of the ingredient.
“PE must remain an available option for consumers, because Americans deserve the option to choose the safe and effective OTC medications they love and trust,” CHPA President and CEO Scott Melville said in a statement. We do.” statement,
Following the FDA's advisory committee last year, the pharmacy chain CVS said it will pull Any product on its shelves that only contains the product.
Spokespeople for the drugmakers behind the brands did not immediately respond to requests for comment.
FDA proposal limits pressure from University of Florida pharmacy professors Have requested The agency pulled the product for years, pointing to new data showing that phenylephrine was no better than placebo when swallowed.
The latest data show that only a small fraction of phenylephrine is absorbed into the body when a tablet or syrup containing phenylephrine is digested. This differs from other formulations, such as inhaled nasal spray versions of the drug, where a larger percentage of the drug can make it into the bloodstream.
Researchers have also questioned the early studies that were run to prove the drug's effectiveness, although they acknowledge that it is safe at currently accepted levels.
“Let me be clear, oral phenylephrine is not a safety risk,” Hatton, the University of Florida professor, told CBS News last year. “It just doesn't work.”
in a scientist Review Published by the FDA this week, agency scientists concluded that previous studies that estimated that a high percentage of the drug could be absorbed during digestion were “overestimates and based on outdated technology.”
They estimate that less than 1% of the drug is absorbed into the bloodstream after swallowing. “Much higher doses may be required to achieve clinically meaningful results which would raise important questions about safety.”
“Additionally, there are no clinical data indicating that oral PE is as effective as nasal decongestants at any dose,” the FDA scientists wrote.