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FDA committee to review OTC decongestants


ROCKVILLE, Md. The Nonprescription Drugs Advisory Committee will consider the possibility of a revision to the final monograph for over-the-counter decongestants following a review of the safety and efficacy of phenylephrine in a Dec. 14 meeting, FDA said in a notice prepared for the Oct. 24 Federal Register, according to the Tan Sheet.

The meeting is one day after the FDA considers the potential switch of Merck’s Mevacor for the third time.

At the Dec. 14 meeting, the committee will discuss questions on the safety and effectiveness of PE hydrochloride and PE bitartrate in nonprescription decongestants raised in a Feb. 1 citizen petition.

The petitioners—University of Florida pharmacy professors Leslie Hendeles and Randy Hatton—assert that available data does not support the adult and pediatric dosing levels recognized as safe and effective in the monograph for OTC cough, cold, allergy, bronchodilator and antiasthmatic drug products. They requested FDA revise the monograph to increase the adult dose of PE hydrochloride from 10 mg to 25 mg and PE bitartrate from 15.6 mg to 40 mg.

Last week a pair of FDA advisory committees voted to discontinue the recommendation of children’s cough-and-cold remedies for children under the age of six. 

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