Does this over-the-counter decongestant really work? FDA panel to re-evaluate phenylephrine

Does a common ingredient used in many over-the-counter cold and allergy medicines actually work to get rid of nasal congestion?

That’s the question the Food and Drug Administration will pose to a panel of outside advisers during a two-day meeting next week to re-evaluate the effectiveness of the ingredient, phenylephrine, which is found in many decongestants.

Phenylephrine was approved by the FDA for over-the-counter use in the 1970s. It comes in several forms, including liquids, pills and nasal sprays.

The committee will focus specifically on the oral formulations of the ingredient, which can be found in drugs including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion.

The stakes are high, experts say, because a committee vote declaring phenylephrine ineffective as an oral decongestant could push the FDA to revoke the drug’s over-the-counter designation as “Generally Recognized as Safe and Effective,” and potentially lead to it being pulled from stores shelves. The designation, typically used for older drugs, allows drugmakers to include an ingredient in over-the-counter products without the need to file an FDA application.