FDA official announcements or updates on their website

FDA to Phase Out Phenylephrine from Cold Medicines Like Sudafed, Dayquil Due to Ineffectiveness

Dec 23, 2024, 04:53 PM

The U.S. Food and Drug Administration (FDA) has announced plans to phase out phenylephrine, a key ingredient found in many over-the-counter cold and allergy medications like Sudafed and Dayquil, due to its ineffectiveness in relieving nasal congestion. Phenylephrine, which accounts for approximately $1.8 billion in annual U.S. sales, has been questioned by experts for its efficacy. The FDA's decision follows a unanimous vote by federal advisers last year, who determined that oral phenylephrine does not outperform a placebo in clearing nasal passageways. The move is expected to lead to the reformulation or removal of products containing phenylephrine. Consumers may need to turn to alternatives such as pseudoephedrine, which is available behind pharmacy counters, or use nasal sprays and solutions like saline drops and nasal steroids for relief.