The U.S. government will ask a panel of outside experts whether new formulations of Sudafed and other over-the-counter cold medications actually relieve nasal congestion.
The meeting comes after researchers at the University of Florida petitioned the government to examine new ingredients used in the popular medicines, arguing that there is little evidence the reformulated products work in adults or are safe in children.
Manufacturers recently switched to the ingredient phenylephrine from pseudoephedrine after passage of a law requiring all pseudoephedrine products be kept behind pharmacy counters. The law is designed to discourage people from illegal processing cold medications into the stimulant methamphetamine.
Sudafed-maker Johnson & Johnson, Procter & Gamble Co. and Wyeth all launched versions of their medicines with phenylephrine to keep them on store shelves. Many of the old formulations are still available behind the counter, though their sales have declined.
Petitioners say the current 10 milligram dosage of phenylephrine isn't much better than a dummy pill at relieving congestion. They recommend raising the dose to 25 milligrams for adults and halting use of the drugs in children younger than 12, arguing there is little evidence they are safe or effective in youngsters.
The Consumer Healthcare Products Association, which represents over-the-counter drug makers, has sent FDA results from seven studies that it says prove phenylephrine medicines work.
"Phenylephrine has been relieving peoples congestion for decades, and we believe this meta-analysis reaffirms that," said spokeswoman Elizabeth Funderburk. "It refutes the contention that phenylephrine in its 10-milligram dose does not provide effective nasal decongestion."
Announcement of the Dec. 14 meeting comes days after Food and Drug Administration advisers dealt over-the-counter drug makers a harsh blow, recommending cold medicines not be used by children less than 6 years old. The panelists also said the medicines should be studied further, even after they have been used for decades of in millions of children. FDA is not required to follow the group's advice, though it usually does.
The American Academy of Pediatrics and other health advocates said the medicines should not be used in anyone younger than 12, though FDA's panel stopped short of supporting that recommendation.