FDA Plans to Ban Popular Cold Med

The FDA announced on Thursday a proposed order to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) nasal decongestion drugs after a comprehensive review of the available data showed it was not effective.

The agency pointed out that since this is a proposed order companies can continue to market these products until the final order is announced. The order is not based on safety concerns.

“It is the FDA’s role to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER). “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.”

During a briefing on the proposed order, Peter Stein, MD, director of CDER’s Office of New Drugs, noted that this change does not apply to nasal spray products intended for temporary relief of nasal congestion.

“Today’s proposed order demonstrates the continued role of the FDA to ensure that Americans have access to medicines that are not only safe, but they’re safe and effective,” he added.

Theresa Michele, MD, director of the Office of Nonprescription Drugs, also provided guidance to consumers during the briefing.

“If your drug product contains oral phenylephrine, you may continue to use it,” she said. “Some nonprescription drug products contain other active ingredients, such as acetaminophen, in addition to phenylephrine. The presence of phenylephrine in these products does not affect how the other active ingredients work to treat those symptoms.”

Michele also emphasized that there are still “a range of safe and effective drugs and other treatments” available OTC that are intended to provide temporary relief for nasal congestion.

When pseudoephedrine moved “behind-the-counter” nearly 20 years ago, products containing oral phenylephrine — including brands such as Sudafed PE and Suphedrine PE — have been the only nasal decongestants available without the need for a prescription.

Last year, the agency released its findings from a long-running review of the available scientific evidence on oral phenylephrine, which showed that it didn’t work as a nasal decongestant. Using these findings, the Nonprescription Drug Advisory Committee met to discuss the “generally recognized as safe and effective” status of oral phenylephrine in these nasal decongestant products.

The committee concluded that current evidence did not support the recommended doses of the ingredient in OTC products for a variety of drugs, including cold, cough, allergy, bronchodilator, and anti-asthmatic drugs.

The FDA said it will issue a final order for removing oral phenylephrine from OTC drugs and these products will no longer be allowed to contain oral phenylephrine. It also said it will provide manufacturers of those products with enough time to either reformulate drugs containing oral phenylephrine or remove those drugs from the market entirely.

The agency is also seeking public comments on the proposed order at this time.