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RESEARCH REPORTS |
1 Co-Director, Drug Information and Pharmacy Resource Center, Shands at the University of Florida, Clinical Professor, University of Florida College of Pharmacy, PO Box 100316, 1600 SW Archer Road (G225), Gainesville, FL
2 Assistant Professor, Department of Pharmacy Healthcare Administration, College of Pharmacy, University of Florida
3 At time of writing Doctor of Pharmacy Student at the University of Florida, now Pharmacy Practice Resident, Sarasota Memorial Hospital
4 Division of Biostatistics, Department of Epidemiology and Health Policy, College of Medicine, University of Florida
5 Professor of Pharmacy and Pediatrics, Colleges of Pharmacy and Medicine, University of Florida
* To whom correspondence should be addressed. E-mail: hatton{at}ufl.edu.
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Abstract |
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DISCLAIMER: Due to public interest in the safety and efficacy of phenylephrine and the scheduled appearance of Dr. Hendeles on the television program Good Morning America on January 31, 2007 to discuss this topic, The Annals of Pharmacotherapy is providing free early access to this article. This is an unedited version of the authors' original draft and may differ from the final edited copy which will appear in the March 2007 issue of the journal.
BACKGROUND: Oral phenylephrine is used as a decongestant, yet there is no published systematic review supporting its efficacy and safety.
OBJECTIVE: To assess the efficacy and safety of oral phenylephrine as a nonprescription decongestant.
METHODS: English and non-English language studies through January 2007 in MEDLINE, CCTR, EMBASE, International Pharmaceutical Abstracts, Federal Register, personal files, hand search of references, and a Web of Science cited reference search were included. Randomized, placebo-controlled trials were included that measured the effects of oral phenylephrine on nasal airway resistance (NAR) in patients with nasal congestion. Studies of combination products were excluded. Two investigators independently extracted data on NAR, self-reported decongestant effects, and cardiovascular effects (i.e., heart rate and blood pressure) from each of the included studies. Meta-analyses were performed for NAR and cardiovascular effects. Subjective decongestant effects were summarized
RESULTS: Based on 8 unpublished studies that included 138 patients, phenylephrine 10 mg did not affect NAR more than placebo; the mean maximal difference in relative change from baseline between phenylephrine and placebo was 10.1%, [95% confidence interval, (95% CI) -3.8%, 23.9%]. Eight unpublished studies on phenylephrine 25 mg showed a significant reduction of maximal NAR compared to placebo of 27.6%, [95% CI, 17.5%, 37.7%]. There was significant heterogeneity among the studies included in this analysis, which was partially attributable to different laboratories and methods used. Patient-reported decongestion was not consistently better for any phenylephrine dose compared with placebo, and nasal airway resistance was a more sensitive measurement of efficacy. Phenylephrine showed no consistent effect on heart rate or blood pressure for doses 
25 mg.
CONCLUSIONS: There is insufficient evidence that oral phenylephrine is effective for nonprescription use as a decongestant. The FDA should reclassify oral phenylephrine from Category I (safe and effective) to Category III, which requires additional studies to show safety and efficacy.
Key Words: phenylephrine, nasal airway resistance, nasal decongestants, nonprescription, meta-analysis
Reprints: Dr. Hatton, University of Florida College of Pharmacy, PO Box 100316, 1600 SW Archer Road (G225), Gainesville, FL, 32610-0316, 352/265-0408, fax 352/265-1091, hatton@ufl.edu
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