Phenylephrine Lawsuit Investigation: Decongestants Are Ineffective, FDA Panel Says

Attorneys working with ClassAction.org would like to speak to New York residents who purchased certain over-the-counter (OTC) cold, flu and allergy medications containing a decongestant known as phenylephrine.

In September 2023, a panel of FDA advisors unanimously agreed that the ingredient, when taken orally, does not work to relieve nasal congestion.  

Now, attorneys are investigating whether a class action lawsuit can be filed to help consumers get back some of the money they spent on ineffective cold and allergy medications. The New York Times reports that phenylephrine is found in “at least 250 products that were worth nearly $1.8 billion in sales last year.”

What Brands Sell Decongestants with Phenylephrine? 

Attorneys working with ClassAction.org are specifically looking to speak with New York consumers who purchased the following phenylephrine-containing products:

Cold medications that do not specifically say they target congestion likely do not contain phenylephrine.

Also, keep in mind that there are two similar-sounding oral decongestants – phenylephrine and pseudoephedrine. Medications containing pseudoephedrine – which is not involved in the recent FDA advisory vote – are typically sold behind the pharmacy counter and require proof of identification upon purchase because they can be used to make methamphetamine.

Lastly, medicines containing phenylephrine may contain “PE” on their packaging.

FDA and Phenylephrine: What Happened?

On September 12, 2023, an FDA advisory committee voted 16-0 that current evidence does not show that phenylephrine is effective, backing the results of a recent agency review that found “numerous flaws” in the decades-old studies that helped support phenylephrine’s original approval.  

The vote could potentially lead the FDA to take phenylephrine off the list of approved pill and liquid decongestants, resulting in the removal of hundreds of products containing the decongestant from the market.

Notably, the ruling pertains only to oral uses of phenylephrine – meaning nasal sprays containing the ingredient are still considered effective. Further, the vote does not mean phenylephrine-containing products are dangerous; experts have advised consumers not to panic and throw out the drugs as these medications may very well contain other ingredients that can help fight cold and flu symptoms.

[UPDATE] According to news reports, CVS Health, as of mid-October 2023, has begun to voluntarily pull from store shelves some cold and flu treatments that contain phenylephrine. 

Specifically, the Associated Press writes that CVS, with more than 9,000 stores nationwide, will remove “a small number of oral decongestants” that contain phenylephrine as the only active ingredient. 

At this time it is unclear whether other retail pharmacy chains, such as Walgreens, will follow CVS’s lead and remove products whose active ingredient is phenylephrine from stores.

How Could a Class Action Lawsuit Help?

If filed and successful, a class action lawsuit could help consumers get back some of the money they spent on these ineffective products. Attorneys believe many consumers wouldn’t have purchased the medicines if they knew they weren’t as effective as advertised.

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