FDA scrutinizes cold drug ingredients.FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. will ask a panel of outside experts whether new formulations of Sudafed and other OTC OTC
See over-the-counter market (OTC). cold medications actually relieve nasal congestion.
The meeting comes after researchers at the University of Florida University of Florida is the third-largest university in the United States, with 50,912 students (as of Fall 2006) and has the eighth-largest budget (nearly $1.9 billion per year). UF is home to 16 colleges and more than 150 research centers and institutes. 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 phenylephrine /phen·yl·eph·rine/ (-ef´rin) an adrenergic used as the hydrochloride salt for its potent vasoconstrictor properties.
n. from pseudoephedrine pseudoephedrine /pseu·do·ephed·rine/ (-e-fed´rin) one of the optical isomers of ephedrine; used as the hydrochloride or sulfate salt as a nasal decongestant.
n. 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's maker Johnson & Johnson, Procter & Gamble 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 placebo at relieving congestion The condition of a network when there is not enough bandwidth to support the current traffic load.
congestion - When the offered load of a data communication path exceeds the capacity. . 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 Assn, which represents OTC 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 CHPA 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 FDA advisers dealt OTC 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 The American Academy of Pediatrics ("AAP") is an organization of pediatricians, physicians trained to deal with the medical care of infants, children, and adolescents. Its motto is: "Dedicated to the Health of All Children. 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.