FDA proposes ending use of decongestant present in many cold medicines

The Food and Drug Administration on Thursday proposed ending the usage of a standard ingredient present in many popular over-the-counter cold and allergy medications.

The agency said an in depth review of obtainable data determined that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion. It comes greater than a yr after advisors to the FDA unanimously reached the identical conclusion.

Based on the information, “we’re taking this next step in the method to propose removing oral phenylephrine since it will not be effective as a nasal decongestant,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release.

The FDA said the proposed order will not be based on safety concerns and will not be final yet, which implies corporations can still market over-the-counter drugs containing oral phenylephrine for now. But a final decision would force pharmacies to clear shelves of lots of of products containing oral types of the ingredient, which is present in versions of medication corresponding to NyQuil, Benadryl, Sudafed and Mucinex.

Last yr, CVS said it has already moved to drag certain medicines containing oral phenylephrine.

A final order would also require drugmakers corresponding to Procter & Gamble, Bayer, and Johnson & Johnson spinoff Kenvue to reformulate a lot of their oral cold and allergy products. 

Phenylephrine is assumed to alleviate congestion by reducing the swelling of blood vessels within the nasal passages. Without oral phenylephrine in the marketplace, patients will likely scramble to hunt down spray versions of the drug, or other medications with different ingredients, each of which the FDA’s decision doesn’t affect.

Retail stores corresponding to CVS and Walgreens could also take a success: Those stores sold 242 million bottles of medication containing phenylephrine in 2022, which generated nearly $1.8 billion in sales, based on a presentation by FDA staff last yr.

The FDA could specifically revoke the drug’s over-the-counter designation as “generally recognized as secure and effective.” The designation, typically used for older medicines, allows drugmakers to incorporate an ingredient in over-the-counter products without the necessity to file an FDA application.

The meeting of FDA advisors last yr was prompted by researchers on the University of Florida, who petitioned the agency to remove phenylephrine products from the market based on studies showing they did not outperform placebo pills in patients with cold and allergy congestion. 

The identical researchers also challenged the drug’s effectiveness in 2007, however the FDA allowed the products to stay in the marketplace pending additional research.

Nevertheless, FDA staff, in briefing documents posted ahead of the panel meeting last yr, concluded that oral formulations of phenylephrine don’t work at standard and even higher doses. The staff said only a really small amount of phenylephrine actually reaches the nose to alleviate congestion. 

Representatives for the Consumer Healthcare Products Association, a bunch that represents over-the-counter drug manufacturers, didn’t offer any recent evidence to counter the FDA staff’s conclusion about phenylephrine through the meeting last yr.

However the group argued that pulling oral phenylephrine from the market can be a big burden to consumers.

The group shared a survey that found 1 in 2 households within the U.S. used an oral decongestant over the past yr. It also found people prefer oral decongestants over nasal spray by a 3-to-1 margin.

Phenylephrine became the primary decongestant in over-the-counter cold and allergy medicines in 2006, when sales of one other decongestant, pseudoephedrine, were restricted within the U.S. 

Pseudoephedrine was moved behind the pharmacy counter because it may well be misused to make methamphetamine, a highly addictive stimulant drug that affects the central nervous system.