FDA unveils over-the-counter cold and flu medications that are no better than placebo

Thousands of cold and flu products could be on the chopping block after the FDA proposed pulling medications containing phenylephrine from store shelves.

The agency this week proposed halting the use of phenylephrine — an ingredient in common medications such as Sudafed — in nonprescription products because it is “ineffective.”

Although it is sold under recognizable brand names such as Sudafed, the drug is also available under cheaper store brand names, including pharmacy giants CVS, Walgreens and Rite Aide.

And when looking for a cold or flu remedy, consumers should pay special attention to the “active ingredients” label, which lists the active medications in each product.

Any medications containing only phenylephrine should be passed, based on the FDA’s findings.

Some popular options include CVS Health’s Non-Drowsy Nasal Decongestant and Rite Aid’s Maximum Sinus Pressure and Congestion Relief.

Both products claim to temporarily relieve sinus pressure and sinus and nasal congestion due to allergies or colds.

Shortly after the FDA determined the ingredient was ineffective, CVS began producing products containing only phenylephrine.

Other well-known products include Sudafed sinus congestion and children’s nasal decongestant; and Walgreen’s Non-Drowsy Nasal Decongestant.

Likewise, these claim to provide relief from nasal congestion, sinus pressure, and nasal congestion.

But if phenylephrine is listed alongside other active ingredients, the product may still be effective in treating other cold and flu symptoms.

Phenylephrine is often used in combination with diphenhydramine in Benadryl allergy medications.

Diphenhydramine is an antihistamine that can treat allergy symptoms such as itching, congestion, watery eyes, sneezing, and runny nose.

Phenylephrine is also commonly used alongside acetaminophen, the generic name for the painkiller and fever reducer Tylenol.

The two medications are used in combination in cold medications to help treat congestion and sinus pain or headaches, and to clear up fevers.

Some of these products include Vicks and Dayquil cold and flu therapies.

Finally, dextromethorphan – a cough suppressant – is often seen as an active ingredient with phenylephrine.

Customers will find this combination in many Mucinex products that attempt to reduce congestion, relieve discomfort and stop a chronic cough.

When looking for a cold or flu remedy, consumers should pay particular attention to the “active ingredients” label, which lists the active medications in each product.

In the fall of 2023, an FDA committee met to discuss the status of phenylephrine and, based on new data, unanimously concluded that “current scientific data does not support the effectiveness of phenylephrine as a nasal decongestant.”

The agency determined that the drug is no more effective than a placebo when taken orally.

However, when phenylephrine is used in medications alongside other drugs — which will not be affected — the FDA said it “does not affect how other active ingredients work to treat the symptoms they are intended to treat.”

Although the FDA made the recommendation this week, it is only a “proposed order” and will have no immediate impact on the drugs.

Only a “final order” will affect the products sold, which could have a major impact on the $1.8 billion in sales generated by these drugs.

The FDA also noted that its conclusion applies only to phenylephrine taken orally, and not intranasally to common nasal decongestants.

Phenylephrine became popular in the mid-2000s when the federal government imposed new restrictions on the purchase of pseudoephedrine, an ingredient that can be used to make the drug meth.

Recommended in doses of 10 milligrams every four hours for temporary relief, the drug works by shrinking the dilating blood vessels in the nose, relieving nasal and sinus congestion.