A common cold medicine has been deemed ineffective and will no longer be available for purchase.
The Food and Drug Administration announced its intention last week to remove oral phenylephrine, a common ingredient in over-the-counter cough and cold medicines, from the market, according to CBS News. The decision follows the agency’s scientists’ conclusion that the oral form of the drug is ineffective as a nasal decongestant.
“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,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a news release.
The FDA’s proposal comes more than a year after its outside advisers voted against the continued use of oral phenylephrine, citing concerns with the initial data supporting its approval and new data questioning its effectiveness. The proposed order would remove oral phenylephrine from the list of ingredients that drugmakers can use in over-the-counter cough and cold medicines.
The public has until May 7 next year to comment on the proposal. If the FDA finalizes its decision to revoke oral phenylephrine’s status as “generally recognized as safe and effective,” drugmakers would need to reformulate or remove products containing the ingredient, according to CBS News.
The Consumer Healthcare Products Association expressed disappointment with the FDA’s proposal.
“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,” said Scott Melville, CHPA’s president and CEO, in a statement.
The FDA noted that higher doses needed for effectiveness could raise safety concerns.
“Furthermore, there are no clinical data demonstrating that oral PE is effective as a nasal decongestant at any dosage,” said the FDA’s scientists in a scientific review.