Over-the-Counter Oral Phenylephrine: A Placebo for Nasal Congestion

Abstract

The category of over-the counter (OTC) [nonprescription] drugs was established in the United States in 1951 by the Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act. The Kefauver-Harris Amendments to the Act required proof of efficacy for all drugs (prescription and nonprescription) approved after 1938. OTC drugs are marketed under regulations that established a monograph approval process, as well as the New Drug Application process. During the 1970s, the US Food and Drug Administration (FDA) convened panels of experts to review the efficacy and safety of OTC products on the market. The panel on Cough, Cold and Allergy Products determined that phenylephrine (PE) and pseudoephedrine were safe and effective for treating nasal congestion. A final OTC Nasal Decongestant Drugs Products monograph was published in 1994. Manufacturers can market the drugs listed in the monograph, alone or in combination, as long as the ingredients, dosage, and instructions for use list exactly what is required in the monograph. Even though phenylpropanolamine was effective, it was not included in the final monograph because of safety concerns about hemorrhagic strokes primarily when used as an OTC appetite suppressant. Because of the widespread use of pseudoephedrine to illegally make methamphetamine, Congress attached an amendment to the Patriot Act, the Combat Methamphetamine Epidemic Act, placing it “behind the counter” and requiring a photo identification and log of the transaction. This removed pseudoephedrine-containing products (Sudafed and others) from grocery and convenience stores, as well as from “in front of the counter” in pharmacies. The use of PE increased dramatically after 2004, presumably because it was the only “in front of the counter” OTC option. In 2005, we reviewed the existing evidence and questioned whether PE was effective at the FDA-approved dose of 10 mg. Subsequently, we undertook a meta-analysis