April 2007;22(7)-PharmaNote.pub

Volume 22, Issue 7 April 2007 1 During the peak of cough and cold season millions, of Americans find themselves searching through the cold medicine section of the neighborhood store in an attempt to relieve nasal stuffiness and sinus pressure. Until recently, the choice included with the ingredient pseudoephedrine found in over 700 cough and cold remedies. Pseudoephedrine (Sudafed ® ) , phenylpropanolamine , and phenylephrine were three of the oral decongestants deemed safe and effective by the US Food and Drug Administration in 1976 for the relief of nasal congestion caused by the common cold, allergic rhinitis, and sinusitis. After a large, multi-centered trial in 2000 confirming the link between phenylpropanolamine use and hemorrhagic stroke in women, all pharmaceutical manufacturers voluntarily removed it from their products. The FDA estimates that phenylpropanolamine caused between 200 and 500 strokes a year among 18 to 49 year-old users. More recently, after passing the USA Patriot Act (HR 3889, Title VII) in September of 2006, all stores are required to keep pseudoephedrine containing products behind the counter requiring purchasers to show photo identification and sign a log book prior to purchase. These changes are part of a nation-wide effort to reduce home-based “meth labs” that create methamphetamine, a highly addictive street drug derived from pseudoephedrine. Fearing customers would shy away from pharmacists to ask for these products, Pfizer introduced a replacement product containing 10 mg phenylephrine (SudafedPE) that cannot be converted to methamphetamine and has no restrictions. This conversion has left the consumer with a package that looks indistinguishable from the previous product, but with unproven efficacy.