Ineffective over-the-counter (OTC) drugs should be removed from the US market. Despite solid research showing that oral phenylephrine is ineffective as a decongestant, the US Food and Drug Administration has failed to respond to a 2015 citizen’s petition to remove it from the OTC nasal decongestant monograph. Other examples of scientifically proven ineffective OTC medications include guaifenesin as an expectorant, dextromethorphan as a cough suppressant, and chlorpheniramine for cold symptoms.
WeinbergerMHendelesL.Nonprescription medications for respiratory symptoms: facts and marketing fictions. Allergy Asthma Proc. 2018;39:169-176. doi:10.2500/aap.2018.39.4117.
EcclesR.Substitution of phenylephrine for pseudoephedrine as a nasal decongestant. An illogical way to control methamphetamine abuse. Br J Clin Pharmacol. 2006;63(1):10-14. doi:10.1111/j.1365-2125.2006.02833.x.
7.
McCoulED.Assessment of pharmacologic ingredients in common over-the-counter sinonasal medications. Otolaryngol Head Neck Surg. 2020;146(9):810-815. doi:10.1177/0194599820969177.
8.
HendelesLHattonRC.Oral phenylephrine: an ineffective replacement for pseudoephedrine? [Letter]. J Allergy Clin Immunol. 2006;118:279-280. doi:10.1016/j.jaci.2006.03.002.
9.
HattonRCWintersteinAGMcKelveyRMShusterJHendelesL.Efficacy and safety of oral phenylephrine: a systematic review and meta-analysis. Ann Pharmacother. 2007;41:381-390. doi:10.1345/aph.1H679.
10.
ShusterJJHattonRCHendelesLWintersteinA. Reply to discussion of empirical vs. natural weighting in random-effects meta-analysis. Stat Med. 2010;29(12):1272-1281. doi:10.1002/sim.3842.
11.
KollarCSchneiderHWaksmanJKrusinskaE.Meta-analysis of the efficacy of a single dose of phenylephrine 10 mg compared with placebo in adults with acute nasal congestion due to the common cold. Clin Ther. 2007;29(6):1057-1070. doi:10.1016/j.clinthera.2007.05.021.
12.
HendelesLHattonRCWintersteinAG. Citizen’s Petition 2007-P-0047: Amend the Dosage of Oral Phenylephrine Listed in the Final Monograph on Oral Decongestants.
13.
DoorenJC.Update: FDA panel: sees some evidence decongestants work. Dow Jones Newswires. December14, 2007.
14.
HorakFZieglmayerPZieglmayerR, et al. A placebo-controlled study of the nasal decongestant effect of phenylephrine and pseudoephedrine in the Vienna challenge chamber. Ann Allergy Asthma Immunol. 2009;102(2):116-120. doi:10.1016/S1081-1206(10)60240-2.
15.
DayJHBriscoeMPRatzJDDanzigMYaoR.Efficacy of loratadine-montelukast on nasal congestion in patients with seasonal allergic rhinitis in an environmental exposure unit. Ann Allergy Asthma Immunol. 2009;102(4):328-338. doi:10.1016/S1081-1206(10)60339-0.
16.
MeltzerEORatnerPHMcGrawT.Oral phenylephrine HCI for nasal congestion in seasonal allergic rhinitis: a randomized, open-label, placebo-controlled study. J Allergy Clin Immunol Pract. 2015;3:702-708. doi:10.1016/j.jaip.2015.05.007.
17.
MeltzerEORatnerPHMcGrawT.Phenylephrine hydrochloride modified-release tablets for nasal congestion: a randomized, placebo-controlled trial in allergic rhinitis patients. Ann Allergy Asthma Immunol. 2016;116(1):66-71. doi:10.1016/j.anai.2015.10.022.
18.
HendelesLHattonRC. Citizen’s Petition 2015-P-4131-0001: Requesting a Final Rule Removing Oral Phenylephrine from the Final Monograph for OTC Nasal Decongestant Products. Accessed February 23, 2022. https://www.regulations.gov/document/FDA-2015-P-4131-0001.
19.
GelotteCKZimmermanBA.Pharmacokinetics, safety, and cardiovascular tolerability of phenylephrine HCI 10, 20, and 30 mg after a single oral administration in healthy volunteers. Clin Drug Investig. 2015;35:547-558. doi:10.1007/s40261-015-0311-9.
20.
KeysAViolanteA.Cardio-circulatory effects in man of neosynephrine. J Clin Invest. 1942;21:1-12.
21.
DeSutterAISaraswatAvan DrielML. Antihistamines for the common cold. Cochrane Database Syst Rev. 2015(11):CD009345.
22.
SmithSMSchroederKFaheyT. Over-the-counter (OTC) medications for acute cough in children and adults in community settings. Cochrane Database Syst Rev. 2014(11):CD001831.
