Last fall, the Food and Drug Administration (FDA) recommended discontinuing the use of oral phenylephrine in over-the-counter (OTC) cold and cough products due to concerns over its effectiveness. This decision has raised questions about which phenylephrine products are affected and what alternatives are available for managing nasal congestion, particularly as cold and flu season approaches.
Sonali Kshatriya, a pharmacist and manager at Walgreens, shares insights into the FDA’s proposal and provides guidance on choosing effective products for congestion relief.
Q: How does the FDA review OTC medications?
A: The FDA regulates OTC medications through two pathways: the standard drug application process and the OTC Drug Review, commonly used for older drugs. The latter allows the FDA to designate ingredients as GRASE (Generally Recognized as Safe and Effective) for specific uses, enabling manufacturers to include these ingredients without separate approval. However, the FDA can amend the GRASE status of a drug based on new findings.
Q: How does this proposal affect the use of phenylephrine?
A: The FDA’s proposal pertains only to oral forms of phenylephrine, such as tablets and liquids. After reviewing studies, the FDA determined that oral phenylephrine might not provide meaningful congestion relief when used as directed. This proposal highlights the FDA’s role in updating health recommendations as new data becomes available.
Q: Does the FDA proposal impact all forms of phenylephrine?
A: No, this recommendation only affects OTC oral phenylephrine products. Phenylephrine nasal sprays, which were not part of this review, remain available and unaffected by this proposal.
Q: What is Walgreens’ stance on the FDA’s proposal?
A: Walgreens adheres to FDA guidance and is committed to offering safe and effective care options. Walgreens pharmacists are ready to discuss phenylephrine and suggest alternative products for symptom relief.
Q: What alternatives do you recommend for nasal congestion this cold and flu season?
A: For those seeking alternatives to oral phenylephrine, consider phenylephrine nasal sprays, pseudoephedrine products like Sudafed®, or Walgreens brand equivalents (note: Sudafed PE 10mg oral tablets contain phenylephrine). For congestion due to allergies, antihistamines like loratadine or fexofenadine, and fluticasone nasal spray, may help. Non-medication options such as humidifiers, saline sprays, or neti pots can also be effective. Always follow label instructions and consult a doctor or pharmacist as needed.
Q: Should people discard current phenylephrine products?
A: The FDA’s proposal is based on effectiveness, not safety concerns, so there’s no recommendation to stop selling or using these products. Walgreens is monitoring the FDA’s decision and will keep customers informed. Consumers can consult their healthcare provider for guidance and consider alternative options if desired.
