Nov. 7 (UPI) — The U.S. Food and Drug Administration has determined commonly used oral phenylephrine is “not effective” and has proposed its removal from over-the-counter nasal decongestants.
“It is the FDA’s role to ensure that drugs are safe and effective,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a news release on Thursday.
“Based on our review of available data … we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” Cavazzoni said.
The proposed administrative order would amend the FDA’s over-the-counter monograph M012 standard to remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate from the active ingredients of nasal decongestants because they are not effective.
“It is important to note that some products only contain oral phenylephrine as a single, active ingredient,” FDA officials said. “Others contain oral phenylephrine and another active ingredient, and the presence of oral phenylephrine in these medicines does not affect how other active ingredients work to treat the symptoms for which they are intended.”
The FDA reviewed available data on the safety and effectiveness of oral phenylephrine, which was declared effective as a nasal decongestant 30 years ago.
A Nonprescription Drug Advisory Committee last fall discussed the status of oral phenylephrine as a nasal decongestant unanimously agreed new scientific data on its use does not support oral phenylephrine’s effectiveness.
The FDA would need to finalize the proposed order for it to take effect, and the FDA is accepting online comments on the proposed order. The FDA is accepting comments from Friday through May 7.
Until the order is finalized, companies can continue to market products as nasal decongestants when those products contain phenylephrine as an active ingredient.
The FDA says its proposed order is based on concerns regarding phenylephrine’s effectiveness and has no safety concerns regarding its use.
