FDA proposes removing oral decongestant phenylephrine from OTC meds
by
Contributor since / Followers
Contributor since / Followers
4 weeks ago
Joe Raedle/Getty Images News
- The U.S. FDA is proposing issuing an order that would remove the oral decongestant phenylephrine from many over-the-counter cough and cold medicines as a review has found the drug ineffective.
- The agency said that a comprehensive evaluation examined data from decades ago used to support oral phenylephrine’s initial approval as well as newer data. Other formulations of phenylephrine are not impacted.
- Oral phenylephrine is found in many popular OTC cough and cold remedies including Kenvue’s (NYSE:KVUE) Sudafed, Procter & Gamble’s (PG) DayQuil and NyQuil, and Haleon’s (NYSE:HLN) Robitussin and Triaminic.
- The FDA’s proposed order is not a surprise considering an advisory committee in September 2023 voted that oral phenylephrine lacks effectiveness.
- The following month, CVS Health (CVS) pulled products containing oral phenylephrine from its shelves.