Cold and flu season is in full swing. But will a common ingredient in many cough and cold medicines soon be a thing of the past? In November 2024, the U.S. Food and Drug Administration (FDA) issued a proposal to have oral phenylephrine removed as an active ingredient in certain medicines. This includes many nasal decongestants and cold and allergy medications sold over the counter. Why? Clinical trials show the ingredient could be largely ineffective. Read the latest on the FDA’s actions regarding phenylephrine in this news update.
What is phenylephrine?
Oral phenylephrine (PE) is a common ingredient used in over-the-counter (OTC) drug products. It’s intended to temporarily relieve symptoms of nasal congestion from a cold or allergies. However, several clinical trials have questioned whether it really works or is merely a placebo.
When will the FDA make its final decision?
The FDA is still working toward its final decision regarding phenylephrine. Their proposal is out for public comment until May 7, 2025. The FDA will review public comments before finalizing a decision. As of now, a final order is expected to come sometime in 2026. Until that time, drug products containing oral phenylephrine may still be marketed. However, some pharmacies may elect to voluntarily remove products from their shelves before then.
What should consumers do?
Consumers are advised to read drug labels on OTC medicines to be aware of all ingredients. Drugs containing phenylephrine along with other active ingredients are generally fine to continue with. However, other alternatives may also be available. For questions, it’s recommended consumers talk with their doctor or pharmacist. We’ve also compiled answers to some frequently asked questions on our blog.
Find more information about the FDA’s actions regarding phenylephrine at fda.gov.
