Substitution of phenylephrine for pseudoephedrine as a nasal decongeststant. An illogical way to control methamphetamine abuse

Abstract

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.

The diagnosis and management of rhinitis: An updated practice parameter

“…346,347 In fact, the efficacy of phenylephrine as an oral decongestant has not been well established. 345,348,349 Elevation of blood pressure after taking an oral decongestant is very rarely noted in normotensive patients and only occasionally in patients with controlled hypertension. However, because of variation in patient response, patients receiving oral decongestants should be followed for changes in blood pressure.…”

“…In an effort to reduce illicit production of methamphetamine, restrictions have been placed on the sale of pseudoephedrine in the United States. 345 This has promoted substitution of phenylephrine for pseudoephedrine in many OTC cold and cough remedies. However, phenylephrine, which appears to be less effective than pseudoephedrine, is extensively metabolized in the gut.…”

Aspirin plus Pseudoephedrine (Aspirin Complex) for the Treatment of Symptoms of Upper Respiratory Tract Infection

“…Pseudoephedrine (PSE) is an α-sympathomimetic vasoconstrictor given orally for the relief of nasal congestion. The efficacy and safety of PSE is proven and well established [18]. Aspirin  Complex is provided as a granule formulation in sachets.…”

Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study

“…However, the efficacy of PE HCl 10-mg tablets-the recommended oral dose for adults and children (!12 years) for relief from nasal congestion-has been questioned. 16,18,19 A systematic review and meta-analysis of many of the studies that supported the original 1976 FDA labeling for nonprescription use of PE did not find that PE HCl 10 mg is effective in the treatment of nasal congestion. 20 A study showed that patients with seasonal allergic rhinitis (SAR) who were exposed to grass pollen in an environmental exposure unit and treated with a single dose of 12-mg PE HCl did not show a significant change from baseline in nasal congestion during a 6-hour evaluation period compared with patients treated with placebo in contrast to PDE 60 mg. 21 There was no statistically significant difference between PE HCl 10 mg and placebo in relieving nasal congestion in a second environmental exposure unit study in contrast to a combination of loratadine-montelukast.…”

“…14,15 Accessibility to PDE has been limited in the United States since 2006 with the adoption of legislation calling for a comprehensive system of controls regarding the distribution and sale of drug products potentially used in the illicit production of methamphetamine. [16][17][18] Phenylephrine hydrochloride (PE HCl 10 mg) tablets, another oral decongestant, are marketed for OTC use in the United States for temporary relief from nasal congestion due to the common cold, hay fever, or other upper respiratory tract allergies, and for temporary relief from sinus congestion and pressure. However, the efficacy of PE HCl 10-mg tablets-the recommended oral dose for adults and children (!12 years) for relief from nasal congestion-has been questioned.…”