“Pharmacies Respond to FDA Findings on Oral Phenylephrine Cold Medicines”
As the fall season progresses, pharmacies are encountering a series of challenges, coinciding with the onset of cold and flu season. One significant challenge has been labor-related, with employees from major pharmacy chains like CVS and Walgreens staging protests against working conditions. Adding to these issues, a staple product of these pharmacies, oral phenylephrine cold medicines, has recently been deemed ineffective by the Food and Drug Administration (FDA). As a result, CVS has taken proactive measures to remove these products from their shelves. Here’s a breakdown of what you need to know about this situation.
The FDA’s Investigation: In September, the FDA revealed the outcomes of its inquiry into the effectiveness of oral phenylephrine. This medication is commonly used to address specific cold and flu symptoms, such as nasal congestion and ear and sinus blockage. However, the FDA’s investigation found that the oral form of phenylephrine is ineffective.
Not All Cold Medicines Affected: It’s important to note that not all cold medicines are based solely on oral phenylephrine. The FDA’s findings pertain specifically to cold medicines that rely solely on oral phenylephrine as their active ingredient and not those that contain additional ingredients to address various symptoms.
Nasal Sprays Unaffected: The FDA’s investigation focused solely on oral phenylephrine medications and does not impact phenylephrine-containing nasal sprays. According to the FDA, “Phenylephrine-containing nasal sprays will not be affected by any possible actions taken for phenylephrine in orally administered products.”
Oral Medicines with Multiple Active Ingredients: For products that combine oral phenylephrine with other medications to treat different symptoms, the FDA confirms that the other active ingredients remain effective. Some products contain phenylephrine along with other active ingredients like acetaminophen or ibuprofen, which are effective in treating symptoms beyond congestion.
Safety Concerns: While oral phenylephrine has been found to be ineffective in treating cold and flu symptoms, the FDA has not raised safety concerns when taken at the recommended dosage. The agency emphasizes that the recommended dosage of oral phenylephrine is safe for consumers.
Why CVS is Removing Oral Phenylephrine Meds: CVS has taken the proactive step of removing oral phenylephrine cold medications from its shelves. Although the FDA has not mandated the removal of these products, CVS’s decision reflects a commitment to providing effective remedies to consumers. It’s worth noting that CVS is specifically discontinuing cold medications where oral phenylephrine is the sole active ingredient.
Response from Other Pharmacy Chains: Walgreens, in response to inquiries, stated, “We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps.” Rite Aid was also contacted for comments, and this post will be updated if a response is received.
Potential Impact on Pharmacy Chains: If the FDA ultimately mandates the removal of oral phenylephrine products, it could impact the bottom lines of major pharmacy chains. Cold and flu season is a significant time for these businesses, and as CNBC highlights, the sale of drugs containing phenylephrine amounted to 242 million bottles last year, generating $1.8 billion in sales.
The FDA’s findings regarding oral phenylephrine cold medicines have brought about important considerations for both pharmacies and consumers during this critical time of year.