The Food and Drug Administration on Thursday suggested Stopping use of a standard ingredient present in many popular over-the-counter cold and allergy medications.
The agency said a comprehensive review of accessible data found that the ingredient, oral phenylephrine, doesn’t actually relieve nasal congestion. This got here greater than a yr after FDA advisers unanimously reached the identical conclusion.
Based on the information, “we are taking this next step in the process to suggest the removal of 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, released in an announcement.
The FDA said the proposed order shouldn’t be based on safety concerns and shouldn’t be yet final, meaning corporations can still market over-the-counter medications containing oral phenylephrine for now. But a final decision would force pharmacies to clear their shelves of a whole lot of products that contain oral types of the ingredient, which is present in versions of medicine equivalent to NyQuil, Benadryl, Sudafed and Mucinex.
Last yr, CVS said it has already moved to remove certain medications containing oral phenylephrine from the market.
A final order would also affect drug manufacturers equivalent to Procter & GambleBavarian and Johnson & Johnson Spin off Kenvue to reformulate a lot of their oral cold and allergy products.
Phenylephrine is assumed to alleviate nasal congestion by reducing the swelling of the blood vessels within the nasal passages. Without the marketplace for oral phenylephrine, patients will likely search for spray versions of the drug or other medications with different ingredients that will not be impacted by the FDA's decision.
Retail stores like CVS and Walgreens could also suffer a setback: These stores sold 242 million bottles of phenylephrine-containing drugs in 2022, representing nearly $1.8 billion in sales, in line with a presentation from FDA staff last yr.
The FDA could specifically revoke the drug's over-the-counter label as “generally recognized as safe and effective.” The designation, typically used for older drugs, allows drugmakers to incorporate an ingredient in over-the-counter products without having to submit an FDA application.
Last yr's meeting of FDA advisers was inspired by researchers on the University of Florida, who petitioned the agency to remove phenylephrine products from the market based on studies that showed they didn’t work in patients with colds and allergies had higher effects than placebo pills.
The same researchers also questioned the drug's effectiveness in 2007, however the FDA allowed the products to stay available on the market pending further study.
However, in briefing documents released before the panel meeting last yr, FDA staff concluded that oral formulations of phenylephrine don’t work at standard doses and even higher doses. Staff said only a really small amount of phenylephrine actually reaches the nose to alleviate congestion.
Representatives from the Consumer Healthcare Products Association, a gaggle that represents over-the-counter drug makers, presented no recent evidence during last yr's meeting that would refute FDA staff's conclusion on phenylephrine.
However, the group argued that removing oral phenylephrine from the market would place a major burden on consumers.
The group shared a survey that found one in two households within the U.S. used an oral decongestant within the last yr. People have also been found to prefer oral decongestants over nasal spray by a 3 to 1 ratio.
Phenylephrine became the major decongestant in over-the-counter cold and allergy medications in 2006 when sales of one other decongestant, pseudoephedrine, were restricted within the United States
Pseudoephedrine was brought behind the pharmacy counter because it could possibly be abused to make methamphetamine, a highly addictive stimulant that affects the central nervous system.
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