FDA panel to mull decongestant changes

The cold-drug controversy is widening. Now, the FDA has asked an advisory panel to investigate phenylephrine, a new decongestant ingredient in many over-the-counter remedies. Phenylephrine, or PE, replaced pseudoephedrine in those products when new laws required meds containing the latter to be kept behind the counter. (Pseudoephedrine can be used to make methamphetamine.)

Drug makers using PE in their products include Wyeth, Johnson & Johnson, and Proctor & Gamble. Researchers at the University of Florida asked the government to intervene, arguing that PE at the commonly used dose of 10 mg doesn't work much better than placebo. The researchers recommend raising that dose to 25 mg--and removing the drug entirely from products for kids under 12. The FDA panel will mull the evidence December 14.

- read the article from BusinessWeek

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