Pharmacy Giant CVS Pulls Oral Phenylephrine Cold Medicines Amid FDA Findings: Will Others Follow Suit?

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Pharmacy Giant CVS Pulls Oral Phenylephrine Cold Medicines Amid FDA Findings

New York City, NY – October 20, 2023

It’s been a whirlwind week for the pharmacy world, with an array of challenges confronting these essential healthcare providers just as the cold and flu season approaches. The labor protests by CVS and Walgreens pharmacy staff have already made headlines, and now, a significant development has emerged concerning one of the best-selling products stocked by these pharmacy giants. 

The Food and Drug Administration (FDA) has declared that oral phenylephrine, a key component of numerous cold medicines, is ineffective. As a result, CVS has taken the proactive step of removing these products from its shelves. Here’s what you need to know about this development.

The FDA’s Findings and Implications

In September, the FDA unveiled the results of its comprehensive investigation into the effectiveness of oral phenylephrine. Phenylephrine, a common medication, is often used to alleviate specific symptoms of colds and the flu, such as nasal congestion and the discomfort of blocked ears and sinuses. 

However, the FDA’s research indicated that the oral version of phenylephrine lacks effectiveness in treating these symptoms.

It’s crucial to clarify that not all cold medicines rely solely on oral phenylephrine, nor are they entirely ineffective against cold and flu symptoms. 

The FDA’s focus was on oral phenylephrine-only medications, which, according to their findings, lack efficacy in symptom relief.

Nasal Sprays Unaffected

For those who rely on phenylephrine-containing nasal sprays, there is no need for concern. The FDA explicitly stated, “Phenylephrine-containing nasal sprays will not be affected by any possible actions taken for phenylephrine in orally administered products.” In essence, the FDA’s findings do not cast doubt on the effectiveness of nasal spray versions of the medication.

Combination Products Remain Effective

It’s important to note that oral cold medicines combining phenylephrine with other active ingredients to address additional symptoms remain effective. The FDA clarified, “Consumers should also know that some products only contain phenylephrine. 

Other products contain phenylephrine and another active ingredient (e.g., acetaminophen or ibuprofen) that treats symptoms other than congestion like headaches or muscle aches, and the presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms.”

Safety Assured

While oral phenylephrine may be ineffective in treating cold and flu symptoms, it is not deemed unsafe when used at the recommended dosage. The FDA affirmed, “neither FDA nor the committee raised concerns about safety issues with the use of oral phenylephrine at the recommended dose.”

CVS Takes a Proactive Approach

CVS has opted to proactively remove oral phenylephrine cold medications from its shelves, even though the FDA has not mandated such action yet. This move underscores CVS’s commitment to offering effective remedies to its customers. It’s essential to note that CVS is specifically pulling cold medications in which oral phenylephrine is the sole active ingredient.

Other Pharmacy Chains’ Responses

When contacted for comments, Walgreens stated, “We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps.” Fast Company also reached out to Rite Aid for their perspective and will provide updates as necessary.

Potential Impact on Pharmacy Revenues

Should the FDA mandate the removal of oral phenylephrine products from pharmacy shelves, it could indeed impact the bottom lines of major pharmacy chains. Considering that the cold and flu season is rapidly approaching, it’s worth noting that last year saw the sale of 242 million bottles of drugs containing phenylephrine, generating an impressive $1.8 billion in sales, as reported by CNBC.

As the situation unfolds, patients and pharmacy-goers will be closely watching to see if other major pharmacy chains follow CVS’s lead in responding to the FDA’s findings regarding oral phenylephrine-based cold medications.

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