The U.S. Food and Drug Administration is proposing to remove oral phenylephrine, widely used in cold and cough syrups, as an active ingredient in over-the-counter medications for nasal congestion, the health regulator said Thursday. Given this, it is not effective, the health regulator said on Thursday.
Phenylephrine is widely used in a variety of over-the-counter flu and cold medications, including popular products such as Benadryl, Advil, and Tylenol.
It is also an ingredient in nasal sprays to treat blocked nose.
However, the FDA action pertains only to orally administered phenylephrine, not nasal spray form.
Last year, an outside panel of experts voted unanimously against the effectiveness of orally administered phenylephrine as a nasal decongestant, saying no further trials were needed to prove otherwise.
Companies such as Procter & Gamble and GSK were among several accused in lawsuits of deceiving consumers about cold medicines containing the ingredient.
The FDA is now seeking public comments on this proposed order.
For now, companies can continue to market drug products containing oral phenylephrine as nasal decongestants.
However, the FDA stated that it would provide manufacturers a reasonable time to reformulate oral phenylephrine-containing drugs or remove such drugs from the market.
The Consumer Healthcare Products Association said in a statement It was “disappointed by the FDA’s proposal to reverse its long-established position regarding oral phenylephrine.”
The association said it will review the proposed order and submit comments accordingly.
Tylenol makers Kenview, GSK, Halon and Procter & Gamble did not immediately respond to Reuters requests for comment.
