Limited Data to Support OTC Cold Products' Efficacy, FDA Says

New formulations of OTC cold medications containing phenylephrine may not relieve nasal congestion, FDA reviewers said before an upcoming advisory committee review of the products.

Several studies used to support the products’ efficacy have serious limitations, including lack of a placebo arm, a small number of subjects and varying endpoints, reviewers from the Office of Nonprescription Products said. The agency’s Nonprescription Drugs Advisory Committee will be discussing the products’ safety and effectiveness Dec. 14.

The meeting is being held in response to a citizen petition that said available data do not support the doses of phenylephrine HCl (PEH) and phenylephrine bitartrate (PEB) that the FDA qualifies as generally recognized as safe and effective (GRASE) for OTC use. The petition 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 FDA should require additional studies to demonstrate the safety and efficacy of the higher doses, the petition added.

In reviewing the studies used for the GRASE determination, the agency found that many studies had different designs, populations and outcomes, and many are 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, the FDA reviewers said.

The FDA’s briefing documents can be seen at www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4335b1-04-FDA-vol1.pdf and www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4335b1-05-FDA-vol2.pdf.