FDA recommends stopping use of decongestants in many cold medicines | Real Time Headlines

The U.S. Food and Drug Administration Thursday recommended end use a common ingredients Found in many popular over-the-counter cold and allergy medicines.

The agency said an extensive review of existing data determined that oral phenylephrine Actually not Relieve nasal congestion. It’s been more than a year since FDA consultants made the request unanimously reached the same conclusion.

Based on these data, “we are taking the next step to recommend elimination of oral phenylephrine because it is ineffective 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 is not based on safety concerns and has not yet been finalized, meaning the company can still sell over-the-counter products containing oral phenylephrine for now. But the final decision will force pharmacies to remove hundreds of products containing oral forms of the ingredient, which is found in drugs such as NyQuil, Benadryl, Sudafed and Mucinex.

last year, CVS It said it has begun removing certain medications containing oral phenylephrine from the shelves.

The final order also requires pharmaceutical manufacturers, e.g. Procter & Gamble, bayerand Johnson & Johnson spin off kenviere Reformulation of many oral cold and allergy products.

Phenylephrine is thought to relieve congestion by reducing swelling of blood vessels in the nasal passages. If oral phenylephrine is not available on the market, patients may scramble to find a spray version of the drug or another drug with a different ingredient, and the FDA’s decision will not affect either drug.

Retail stores such as CVS and walgreens Also likely to take a hit: These stores sold 242 million vials of drugs containing phenylephrine in 2022, generating nearly $1.8 billion in sales, according to an FDA staff report last year.

The FDA can specifically revoke the drug’s OTC designation, saying it is “generally recognized as safe and effective.” The name is often used for older drugs and allows drugmakers to add an ingredient to over-the-counter products without submitting an application to the FDA.

Last year’s FDA advisory meeting was initiated by researchers from the University of Florida, who asked the agency to remove phenylephrine products from the market because studies showed they were not effective in treating patients with colds and allergic congestion. in placebo pills.

In 2007, these researchers also raised questions about the drug’s effectiveness, but the FDA allowed the product to remain on the market pending further studies.

However, FDA staff concluded in a briefing document released before last year’s panel meeting that oral formulations of phenylephrine do not work at standard doses or even higher doses. Staff say only a tiny amount of phenylephrine actually reaches the nose to relieve congestion.

Representatives from the Consumer Healthcare Products Association, which represents over-the-counter drug manufacturers, did not present any new evidence at last year’s meeting to refute the FDA staff’s conclusions about phenylephrine.

But the group believes that removing oral phenylephrine from the market would impose a significant burden on consumers.

The organization shared a survey that found 1 in 2 U.S. households used oral decongestants in the last year. The study also found that people preferred oral decongestants to nasal sprays by a ratio of 3 to 1.

Phenylephrine became the main decongestant in over-the-counter cold and allergy medicines in 2006, when sales of another decongestant, pseudoephedrine, were restricted in the United States

Pseudoephedrine was moved behind pharmacy counters because of its potential for abuse to make methamphetamine, a highly addictive stimulant drug that affects the central nervous system.