Decongestant Used in Sudafed, Other Cold Medications Does Not Work, FDA Panel Finds

FDA advisors say a decongestant commonly used in OTC cold medications has low bioavailability, making it ineffective when taken orally. The findings may result in a wave of decongestant recalls in the coming months.

For decades, consumers worldwide have been buying over-the-counter cold, flu and allergy medications which contain a decongestant that doesn’t actually work, according to a panel of scientists and other medication experts.

At a meeting held from September 11 through 13, the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee (NDAC) voted unanimously to inform the agency that the decongestant phenylephrine is no more effective than a placebo. The decongestant is widely used in a number of popular over-the-counter medications, such as Tylenol, NyQuil, and Mucinex cold and flu products.

The ingredient has been on the market for decades, but the new findings contradict several earlier reviews by FDA advisory committees that concluded the ingredient was not only safe but also effective.

Now, the agency must decide whether to remove the ingredient’s approval, which would lead to cold and flu drug recalls of more than 250 products made by major and generic brands, including NyQuil, Tylenol, Mucinex, Theraflu, and Benadryl.

If the FDA follows NDAC’s advice, it could ban phenylephrine and result in a number of decongestant recalls, which observers say could cause many cold and flu medications to be unavailable for months while manufacturers work to reformulate them.

While the FDA is not required to follow the recommendations made by it’s advisory committees, the agency usually does.

Phenylephrine Has Low Bioavailability, FDA Advisors Find

There are two main decongestants on the U.S. market: phenylephrine and pseudoephedrine.

Phenylephrine constricts blood vessels in the nasal passages. It has been on the market for more than 30 years and was supposed to help relieve congestion. It is widely used in popular cold and flu medications like Sudafed, Mucinex and NyQuil.

However, following a NDAC review (PDF) of the available science, the advisory committee determined that only 1% of phenylephrine actually affects the body when taken orally. Previously, it was believed that the decongestant’s bioavailability was closer to about 38%, but the committee determined that estimate was made using outdated technology.

Nasal sprays containing the ingredient are still considered effective, because they have a much larger bioavailability when compared to pills or liquids. They would likely continue to be sold on the market regardless of the FDA’s decision regarding cold and flu tablets and other oral medications.

The alternative is pseudoephedrine, which is used for hay fever or allergic rhinitis. However, sales are restricted, and it is placed behind the counter and in locked cabinets because it is frequently used as an ingredient in illegal methamphetamines, known more commonly as meth.

The number of tablets that can be purchased at one time is capped, and consumers must be 18 years or older and show ID. It is known to raise blood pressure and cause jitters and wakefulness.

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OTC Industry Pushes Back Against Findings

The Consumer Healthcare Products Association (CHPA) issued a statement on September 12, expressing disappointment with the panel’s findings and urging the FDA to keep phenylephrine on the market.

The CHPA said the consequences of removing the ingredient from the market would lead to an increased burden on consumers, who would need to seek alternative treatments or prescriptions from doctors. The statement claims consumers would be unable to self-treat due to the restrictions on pseudoephedrine. Fewer than 20% of retail stores sell products that contain the restricted decongestant, according to CHPA.

The group speculates that a phenylephrine ban could lead to some consumers not seeking treatment at all, which could result in increased doctor visits and medical costs.

The CHPA also argues that the move could raise prices on cold and cough medications, as manufacturers try to reformulate them. This would come at a time when OTC medications are already viewed as expensive, and Americans are currently feeling additional financial pressure due to inflation.

Products containing phenylephrine brought in $1.8 billion in sales last year.


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