FDA committee recommends additional studies on decongestant

WASHINGTON The Food and Drug Administration’s nonprescription drug advisory committee on Friday recommended the FDA commission additional studies on the decongestant phenylephrine, though in discussions the committee did affirm the safety and efficacy of 10 mg phenylephrine.

“Today, the FDA’s expert panel voted almost unanimously [11-1] that the existing evidence supports the effectiveness of phenylephrine at the 10 mg dose and reaffirms the results of numerous scientific studies and decades of consumer experience,” stated Linda Suydam, president of the Consumer Healthcare Products Association following the meeting. “CHPA and the leading makers of OTC cough, cold, and allergy medicines containing phenylephrine are committed to adding to the existing body of evidence currently supporting the safety and efficacy of phenylephrine. Our goal is to continue to provide consumers with safe and effective therapies, and we are committed to working with FDA to ensure that the scientific data further supports this goal,” she said.

Following the migration of pseudoephedrine from cough/cold aisles to behind the counter, many manufacturers reformulated their cough/cold medicines with PE.