FDA Committee to Tackle Adult OTC Cold Medication Next

December 13, 2007
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Tomorrow, Dec. 14, the US Food and Drug Administration?s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine.

Silver Spring, MD (Dec. 13)-Tomorrow, Dec. 14, the US Food and Drug Administration’s Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of over-the-counter (OTC) cold medications containing phenylephrine. The meeting is in response to a citizen position that claimed new formulations of OTC cold medications containing phenylephrine HCl (PEH) and phenylephrine bitartrate (PEB) may not actually relieve nasal congestion.

According to a Dec. 7 announcement from FDA’s Office of Nonprescription Products, a number of studies used to support these OTC medications’ efficacy had problems, such as lack of a placebo arm, small number of subjects, and varying endpoints. Many studies had different designs, populations and outcomes, and several were decades old. Seven of the 14 studies involving 10-mg doses of PEH did not demonstrate a significant effect on nasal decongestion, and the scores were similar for 25-mg doses, said FDA reviewers.
 
The citizen petition, led by University of Florida pharmacists and submitted to FDA in February 2007, proposed that the PEH dose increase from 10 mg to 25 mg and the PEB dose increase from 15.6 mg to 40 mg. The petition also called for FDA to require additional studies to demonstrate the drugs’ safety and efficacy in these higher doses.

Earlier this year, FDA advisory committees recommended that OTC cough and cold medications, including those with phenylephrine, not be used in children under age 6. (See full story)
   
For the full FDA advisory committee briefings, see volume 1 and volume 2.