The U.S. Food and Drug Administration said on Thursday it would seek public opinion before finalizing its decision to remove a decongestant widely used in cough syrups from the agency’s list of ingredients for over-the-counter (OTC) use.
The FDA’s clarification follows a unanimous vote by its panel of outside experts on Tuesday against the effectiveness of oral OTC medicines made with phenylephrine, an ingredient widely used in cold and cough syrups.
If the FDA concurs with the panel’s view, it will first issue a proposed order removing phenylephrine from the list of ingredients that are allowed in OTC drugs, and seek public comment on it.
After considering the comments, if the FDA continues to conclude phenylephrine is not effective, the agency would issue a final order on it and work with manufacturers to reformulate products to effectively treat symptoms of cold or allergies.
Phenylephrine is also linked to birth defects in pregnant women, while pseudoephedrine is not. My wife’s OB recommended sudafed when she had a cold. The pharmacy tech pointed her to the aisle with SudafedPE when she asked for Sudafed. So it’s ineffective and dangerous.
Why am I not surprised.
The FDA is exactly the opposite of what it was mandated for.