With cold and flu season on the rise, the FDA announced on November 7 a proposal to remove oral phenylephrine, a decongestant found in products like Sudafed PE, DayQuil, and Theraflu, after concluding it is ineffective. This decision stems from a recommendation by an FDA advisory committee in September 2023, which determined that oral phenylephrine does not relieve congestion any better than a placebo.

 

 

You might also be interested in the Spanish version: FDA propone retirar un medicamentos para la congestión nasal

 

 

Although some products containing phenylephrine are still available, the FDA’s decision to remove them is final. Pharmacies such as CVS have already begun removing these products, while Walgreens continues to follow FDA regulations.

 

The FDA’s proposal is now open for public comment for six months. If approved, manufacturers will be required to reformulate or remove oral phenylephrine products. As an alternative, experts recommend other decongestants like pseudoephedrine, which is available over the counter with pharmacy assistance.