FDA to hold hearing on phenylephrine dosage efficacy
ROCKVILLE, Md. According to documents posted on the Food and Drug Administration Web site in preparation for a public meeting to be held next week, FDA medical reviewers intimated they aren’t clear how well the over-the-counter decongestant phenylephrine works.
The assessment seems to support a citizen’s petition filed earlier this year by three professors from the University of Florida in Gainesville, who are petitioning the FDA to increase the effective dose of phenylephrine on the basis that the current 10 mg dose isn’t effective. The Florida professors claim a 25 mg dose may work better pending additional study.
Industry representative Consumer Healthcare Products Association stands opposed to the petition, suggesting that PE in its current approved dosage is both adequately safe and efficacious.
Phenylephrine became the decongestant of choice for many cough/cold manufacturers following the migration of pseudoephedrine from OTC aisles to behind the pharmacy counter last year.