FDA Panel Says Cold Drug Is Effective
Phenylephedrine Appears to Work, Experts Conclude
By
Todd Zwillich
WebMD Health News
Reviewed By
Louise Chang, MD
Dec. 14, 2007 -- A widely-sold cold drug appears to be effective in
relieving runny nose and other cold symptoms in adults and
children over 12, a federal advisory panel concluded Friday.
The drug, called phenylephedrine hydrochloride, is a common decongestant
ingredient in cold medicines. Most products use the drug in combination with
other active ingredients, such as pseudoephedrine.
Phenylephedrine has been on the U.S. market for 40 years. But it has come
into new focus because of a 2006 law restricting sales of pseudoephedrine, a
related decongestant. Congress passed a law forcing pharmacies to sell
pseudoephedrine from behind the counter because it can be used as an ingredient
in manufacturing methamphetamine. Meanwhile phenylephedrine remains out on
grocery store and pharmacy shelves.
Americans have bought at least 5 billion doses of the drug since 1996,
according to a consumer products industry lobbying group. But a group of
scientists asked the FDA to review the drug after an analysis suggested the
common 10-milligram dose may be ineffective.
Industry groups showed 14 studies to regulators. Half concluded
phenylephedrine is effective in reducing nasal congestion, but the other half
showed no effect. Each of the studies had different designs; some measured
congestion by machine in a lab, others asked patients about their symptoms.
Yet the scientists who petitioned the FDA said their analysis of available
research shows no benefit to the widely-available 10-milligram oral dose.
"I was really convinced that if you have a stuffy nose and you take
10-milligrams, you're going to still have a stuffy nose," said Leslie
Hendeles, a University of Florida professor of pharmacy and pediatrics and one
of the scientists who filed the petition.
Hendeles and other scientists had asked the agency to revoke clearance for
the 10-milligram dose and instead force companies to study a higher,
25-milligram dose.
In an 11-1 vote, the FDA's advisory panel concluded that available studies
suggest 10 milligrams of phenylephedrine is effective. But experts also said
that existing studies are small and inconclusive, and that companies should
conduct more trials.
"The individual studies show some suggestion of a benefit to the
10-milligram [dose]," said Mary E. Tinetti, MD, a professor of medicine at
Yale University and the panel's chair.
"Overall what we know from studies to date, is that it's murky," she
said.
SOURCES: Consumer Healthcare Products Association. Leslie Hendeles,
professor of pharmacology and pediatrics, University of Florida. Mary E.
Tinetti, MD, professor of medicine, Yale University; chair, FDA advisory
panel.
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