Thousands of cold and flu products could be on the chopping block after the FDA proposed to pull medications from store shelves that contain phenylephrine.
The agency proposed this week discontinuing the use of phenylephrine – an ingredient in common medications like Sudafed – in nonprescription products because it ‘is not effective.’
While sold under recognizable brand names like Sudafed, the drug is also available under less expensive store brand names, including the pharmacy giants CVS, Walgreens and Rite Aide.
And when reaching for a cold or flu remedy, consumers should pay special attention to the ‘active ingredients’ label, which lists the drugs at work in each the product.
Any medications that solely list phenylephrine should be passed over, 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 they temporarily relieve sinus pressure and sinus and nasal congestion due to allergies or the common cold.
Shortly after the FDA determined the ingredient was not effective, CVS began pulling phenylephrine-only products.
Other well-known products include Sudafed’s sinus congestion and children’s nasal decongestant; and Walgreen’s non drowsy nasal decongestant.
Similarly, these claim to provide relief from a stuffy nose, 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 frequently 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 pain reliever and fever reducer Tylenol.
The two drugs are used in combination in cold medications to help treat congestion and sinus pain or headaches, as well as resolve a fever.
Some of these products include Vicks’ and Dayquil’s cold and flu therapies.
Lastly, dextromethorphan – a cough suppressant – is often seen listed as an active ingredient with phenylephrine.
Customers will find this combination in many Mucinex products that seek to decongest, relieve discomfort and stop a chronic cough.
When reaching for a cold or flu remedy, consumers should pay special attention to the ‘active ingredients’ label, which lists the drugs at work in each the product.
In the fall of 2023, an FDA committee met to discuss the status of phenylephrine and based on new data, it unanimously concluded ‘current scientific data do not support… phenylephrine’s effectiveness as a nasal decongestant.’
The agency determined 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 impacted – the FDA said it ‘does not affect how other active ingredients work to treat the symptoms for which they are intended.’
While the FDA made the recommendation this week, it is only a ‘proposed order’ and will not have an immediate impact on the medications.
Only a ‘final order’ will affect the products sold, which could have a major impact on the $1.8billion in sales generated by these drugs.
The FDA also noted that its conclusion only applies to phenylephrine taken orally, not intranasally in common nasal decongestants.
Phenylephrine became popular in the mid-2000s when the federal government imposed new restrictions on purchasing pseudoephedrine, an ingredient that can be used to make the drug meth.
The medication is recommended in 10 milligram doses every four hours for temporary relief and works by shrinking the dilating blood vessels in the nose, relieving nasal and sinus congestion.