The drug will replace a vital ingredient in meth.

Sunday, August 20, 2006 The drug will replace a vital ingredient in meth. SCRIPPS HOWARD Pharmacists at the University of Florida are warning that a popular new ingredient in over-the-counter decongestants is likely to be ineffective at the dose approved by the federal Food and Drug Administration. The drug, phenylephrine, is rapidly making its way into many oral cold and allergy medicines to replace pseudoephedrine, a decongestant whose sale is being more tightly regulated because the drug can be used to manufacture methamphetamine. By the end of next month, all medicines containing pseudoephedrine are going to have to be moved behind drugstore counters to control sales. But in a recent peer-reviewed letter to the Journal of Allergy and Clinical Immunology, University of Florida pharmacists Leslie Hendeles and Randy Hatton, warn that phenylephrine is poorly absorbed into the bloodstream and will not work as well as medicines containing pseudoephedrine. "When it is ingested, it becomes inactivated somewhere between the gut and the liver," said Hendeles, an FDA consultant who served on the agency's pulmonary advisory committee for six years. "More research needs to be done to determine whether higher doses can be effective and safe." With products containing phenylephrine filling the shelves, Hendeles recommends that people seeking relief from congestion try nose sprays with the ingredient instead, especially for stuffiness from a cold lasting less than a week. But he cautioned that people trying to treat congestion from allergies that last longer than a week should avoid phenylephrine products, because a "rebound effect" from it can actually make congestion worse. "Consumers in that situation should go that extra step and get pseudoephedrine from behind the counter," Hendeles said. Increasing doses In 1976, FDA considered a 10-milligram dose of phenylephrine safe and effective for relieving congestion, allowing companies to use the ingredient without conducting clinical studies.