FDA suggests stopping use of decongestants found in many cold and allergy medications

Food and Drug Administration on Thursday proposed discontinuation of use common ingredient found in many popular over-the-counter cold and allergy medications.

The agency said an extensive review of available data showed that the ingredient, oral phenylephrine, not really relieve nasal congestion. This comes more than a year after FDA advisers unanimously came to the same conclusion.

Based on these data, “we are taking the next step in the process to propose discontinuing oral phenylephrine because it is not effective as a nasal decongestant,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in the report. release.

The FDA said the proposed order is not based on safety concerns and is not yet final, meaning companies could still sell over-the-counter drugs containing oral phenylephrine. But the final decision will force pharmacies to clear shelves of hundreds of products containing oral forms of the ingredient, which is found in drug variants such as NyQuil, BenadrylSudafed and Mucinex.

Last year, CVS said it has already taken steps to discontinue certain medications containing oral phenylephrine.

The final order will also require drug manufacturers such as Procter & Gamble, BayerAnd Johnson and Johnson spin off Kenview reformulate many of its oral cold and allergy products.

Phenylephrine is thought to relieve nasal congestion by reducing swelling of the blood vessels in the nasal passages. Without oral phenylephrine on the market, patients will likely seek spray versions of the drug or other medications with different ingredients that will not be affected by the FDA’s decision.

Retail stores such as CVS and Walgreens Also likely to suffer: Those stores sold 242 million bottles of drugs containing phenylephrine in 2022, generating nearly $1.8 billion in sales, according to an FDA staff presentation last year.

The FDA may, among other things, revoke the designation of an over-the-counter drug as “generally recognized as safe and effective.” The designation, typically used for older drugs, allows drug makers to include the ingredient in over-the-counter products without having to file an FDA application.

A meeting of FDA advisers last year was prompted by University of Florida researchers who asked the agency to remove phenylephrine products from the market based on studies showing they failed to outperform placebo pills in patients with colds and allergies.

The same researchers also challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending more research.

But FDA staff, in briefing documents released ahead of a panel meeting last year, concluded that oral forms of phenylephrine do not work at standard or even higher doses. According to the staff, only a very small amount of phenylephrine actually reaches the nose to relieve nasal congestion.

Representatives of the Consumer Health Products Association, a group that represents over-the-counter drug makers, did not present any new evidence to refute FDA staff’s conclusion about phenylephrine during a meeting last year.

But the group argues that stopping the sale of oral phenylephrine would pose a significant burden to consumers.

The group shared the results of a study that found that one in two U.S. households had used oral decongestants in the past year. It has also been found that people prefer oral decongestants to nasal sprays by a 3-to-1 margin.

Phenylephrine became a staple decongestant in over-the-counter cold and allergy medications in 2006, when U.S. sales of another decongestant, pseudoephedrine, were restricted.

Pseudoephedrine was removed from the pharmacy counter because it could be used to make methamphetamine, a highly addictive stimulant drug that affects the central nervous system.