Multiple systematic reviews and health authorities, including the FDA advisory committees, have concluded that oral phenylephrine lacks scientific evidence of efficacy as a nasal decongestant.
The aim of this review was to investigate the rationale for replacing the nasal decongestant pseudoephedrine (PDE) with phenylephrine (PE) as a means of controlling the illicit production of methamphetamine. A literature search was conducted in electronic databases and use of textbooks. Restrictions have been placed on the sale of PDE in the USA in an attempt to control the illicit production of methamphetamine. This has caused a switch from PDE to PE in many common cold and cough medicines. PE is a poor substitute for PDE as an orally administered decongestant as it is extensively metabolized in the gut and its efficacy as a decongestant is unproven. Both PDE and PE have a good safety record, but the efficacy of PDE as a nasal decongestant is supported by clinical trials. Studies in the USA indicate that restricting the sale of PDE to the public as a medicine has had little impact on the morbidity and number of arrests associated with methamphetamine abuse. Restricting the sale of PDE in order to control the illicit production of methamphetamine will deprive the public of a safe and effective nasal decongestant and force the pharmaceutical industry to replace PDE with PE, which may be an ineffective decongestant. Restrictions on sales of PDE to the public may not reduce the problems associated with methamphetamine abuse.
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.
Background: Phenylephrine (PE) is a non-prescription decongestant listed on the Australian Register of Therapeutic Goods (ARTG). However, there are no published systematic reviews supporting the efficacy and safety of this product for this use. Objective: This review examine the efficacy of oral PE as a nasal decongestant for patients aged over 12 years with symptoms of nasal congestion (i.e., allergic rhinitis, influenza-like illness). Methods: PubMed, EMBASE and the Cochrane Central Registry of Controlled Trials were searched for English and non-English studies published through December 2020 that measured the efficacy of phenylephrine in patients with nasal congestion. Studies included in the analysis were randomised, placebo-controlled trials measuring the effects of phenylephrine. Combination products with phenylephrine and other active decongestants were excluded. Two investigators independently extracted data on nasal airway resistance (NAR), self-reported decongestant scores and adverse reactions from each of the included studies. Continuous outcomes including nasal airway resistance and symptom reduction were analysed using weighted mean differences; or standardised mean differences if different measurement scales were used. Results: Three randomised placebo trials evaluating the efficacy and safety of phenylephrine were included for analysis. All three studies demonstrated no statistically significant improvement with PE compared with a placebo in their self-reported symptom scores and in or rhinomanometry results. There was significant heterogeneity among the studies included in this analysis, which was attributed due to different methodologies and scoring systems used. Because of this summarising primary endpoint results was not possible. Conclusions: There is no evidence that phenylephrine is effective for non-prescription use as a nasal decongestant. This is in congruence with previous reviews like Hatton et al. Based on this review, we recommend that the Therapeutic Goods Administration (TGA) review the efficacy and safety of this common ingredient in decongestant products.
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