Phenylephrine replacing pseudoephedrine in new Sudafed product

Previous Sudafed formulation remaining available also, as Pfizer responds to meth-manufacturing challenges.

Sudafed PE, a new Pfizer product in which pseudoephedrine is replaced by phenylephrine, will be available on January 10, according to an article in the New York Times. While Pfizer will continue marketing the current Sudafed product, its action ensures broad availability of its line, even in states that have required that pseudoephedrine products be moved behind pharmacy counters because of problems with diversion for illicit manufacturing of methamphetamine.

Several states have restricted access to OTCs containing pseudoephedrine, and more are expected to do so during the upcoming legislative season. Oklahoma placed pseudoephedrine in Schedule V in April 2004. The formula in Sudafed PE has been sold in Europe for years and has been effective and safe, according to Pfizer.

Methamphetamine comes in a powder form that resembles granulated crystals and in a rock form known as "ice," which is the smokeable version of methamphetamine that came into use during the 1980s. Meth can be made using many common household products such as rubbing alcohol, drain cleaner, acetone, and iodine, but its principal ingredient is pseudoephedrine.

According to the U.S. Department of Health and Human Services' Results From the 2002 National Survey on Drug Use and Health: National Findings, more than 12 million people age 12 and older reported that they had used methamphetamine at least once in their lifetime. Although the problem of meth use is widespread, some believe that placing all products behind the pharmacy counter will not curb the production of methamphetamine because home labs can obtain the needed ingredients illegally. A spokesperson for the National Association of Chain Drug Stores (NACDS) recently testified before Congress on the matter. Vice President of Pharmacy Regulatory Affairs and President of the Pharmacy Care Alliance Mary Ann Wagner, BPharm, stated that meth labs buy pseudoephedrine products illegally by the caseload. Wagner urged Congress not to unduly penalize legitimate customers of OTCs without addressing the larger problem of addiction and criminal use of pseudoephedrine to make meth.