Decongestant in cold medicines doesn't work, committee finds

The agency must now decide whether products containing the ingredient, such as some Sudafed and NyQuil products, should no longer be sold or perhaps give to companies time to replace them with others. ingredients.

A Food and Drug Administration advisory panel unanimously agreed Tuesday that a common decongestant ingredient used in many over-the-counter cold medications is ineffective.

A Food and Drug Administration advisory panel unanimously agreed Tuesday that a common decongestant ingredient used in many cold medications on the market free is ineffective. p>

The panel's vote determines a likely decision by the agency on whether to ban the ingredient, phenylephrine, which would lead to the withdrawal of hundreds of products containing it store shelves.

If the F.D.A. ordered their withdrawal, a trade group warned that many popular products — including cold and flu remedies Tylenol, Mucinex and Benadryl — could become unavailable as companies rush to reformulate them.

Agency officials generally follow the recommendations of advisory committees, but not always, and it can take several months before a final decision is made. And the results could be contested, prolonging any trend toward product substitutions or removal of some inventory from stores.

Meanwhile, experts have advised consumers not to panic or throw away all the products. medications in their medicine cabinet. Although the agency's advisors have decided that the ingredient, phenylephrine, does not relieve nasal congestion when taken orally, it is not dangerous and the products contain other ingredients that will help relieve cold symptoms.

The panel's vote follows Monday and Tuesday's review of several existing studies, with advisers largely concluding that the research has settled the question that the ingredient was useless and no better than a placebo.

Several advisors noted that patients taking this drug were simply delaying their path to a useful remedy .

“I think we clearly have better over-the-counter options to help our patients, and the studies don't support that these are an effective medicine,” said Maria Coyle, panel chair and associate professor of pharmacy at Ohio State University.

“If you have a stuffy nose and you take this medicine, you will always have a stuffy nose,” said Dr. Leslie Hendeles, a pharmacist at the University of Florida. in Gainesville who, along with his colleagues, first petitioned the F.D.A. in 2007 to remove the drug from the market.

Every cold and flu season, millions of Americans turn to these products, some over several decades. The decongestant is present in at least 250 products that accounted for nearly $1.8 billion in sales last year, according to an agency presentation. Among the products: Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max and others.

There are two main ones oral decongestants found in products on store shelves: phenylephrine and pseudoephedrine.

According to the agency's old, outdated standards, phenylephrine, which constricts blood vessels in nasal passages, has long been considered safe. and effective, and the F.D.A. still says it is safe.

Nasal sprays containing the ingredient are still considered effective, as well as when used in surgery or to dilate the eyes . Nasal sprays containing another ingredient, oxymetazoline, are also effective for nasal congestion.

Other medications to relieve cold congestion include those containing oral pseudoephedrine and against hay fever. or allergic rhinitis, nasal steroids, such as Flonase, as well as nasal antihistamines and oral pseudoephedrine.

Many popular cold and flu products that do not do not specifically target congestion do not do so. include the ingredient.

If the agency decides that the decongestant must be eliminated from products, it could significantly disrupt the market for cold medicine manufacturers. They don't have enough time...