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.
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.
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 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.
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.
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. »
