At the maximum 10 milligram dose, phenylephrine is no more effective than a placebo.
FYI for those of you who have colds. The new drug in nasal decongestants doesn't work so hot.
Here is a link.
Many cold meds aren't what they used to be
Robert Cohen, Newhouse News Service
Last update: November 24, 2006 - 8:46 PM
WASHINGTON - Nose stuffed up? Grabbing a decongestant from the drugstore or supermarket shelf may not provide the relief it did just weeks ago.
Makers of dozens of nonprescription oral nasal decongestants sold under familiar brand names such as Dimetapp, Sudafed, Tylenol, Vicks, Benadryl and Triaminic recently changed an active ingredient in some of their products to avoid a new federal mandate that the meds be sold behind the counter.
Now a number of pharmaceutical experts and one influential member of Congress are questioning whether replacing pseudoephedrine -- which is subject to sales restrictions -- with the ingredient phenylephrine has made many of the over-the-counter remedies largely useless in clearing up nasal congestion.
"At the maximum 10 milligram dose, phenylephrine is no more effective than a placebo. It's like shooting blanks," said Leslie Hendeles, a research pharmacist at the University of Florida.
John Colazzi, dean of Rutgers University's Ernest Mario School of Pharmacy, said phenylephrine had not been widely used for years because of its "limited effectiveness."The impression I have is that phenylephrine isn't that good of a nasal decongestant, and not as effective as pseudoephedrine," Colazzi said.
Drugmakers began switching to phenylephrine as an active ingredient for some of their nonprescription decongestants and allergy medicines because of the Combat Methamphetamine Act, which was signed into law in March by President Bush and went into effect on Sept. 30.
Under that law, any medicines that can be used in the illegal production of methamphetamine, including pseudoephedrine, have to be kept behind store counters, with customers showing an ID, signing a log book and facing a limit on how much they can purchase.
Phenylephrine was the only alternative for drugmakers wanting to keep their products on open store shelves; a third ingredient, phenylpropanolamine, or PPA, was voluntarily withdrawn in 2000 because strokes were associated with its use.
Rep. Henry Waxman, D-Calif., a longtime pharmaceutical industry watchdog, has twice asked the FDA to convene an expert advisory committee to review all the available data on phenylephrine because of the concerns about its effectiveness, but his pleas have been rejected.
Waxman recently renewed his request to the FDA, citing a newly completed small clinical trial conducted by drugmaker Schering-Plough.
That study of 38 subjects compared phenylephrine with a placebo and pseudoephedrine. It found phenylephrine was "not significantly different from placebo in decreasing nasal congestion" while pseudoephedrine was "significantly more effective."
Schering spokeswoman Julie Lux said the company decided not to reformulate its popular Claritin-D allergy product after reviewing its clinical study and because of "the strong clinical data on the proven long-lasting effectiveness of our key ingredient pseudoephedrine."
Waxman said Schering-Plough's decision not to switch ingredients and to keep Claritin-D behind the counter could mean a loss of market share.
Many drugmakers have chosen a dual route -- keeping their established name-brand products with pseudoephedrine on the market and available behind the counter, while offering a second reformulated version containing phenylephrine that can be displayed on open store shelves.
Suman Wason of the Wyeth consumer health medical affairs group said his company has chosen the two-track approach with its Dimetapp and Robitussin cold remedies.
Michael Beckerich of McNeil Consumer Health Care, a subsidiary of Johnson & Johnson, said his company will take the same approach with its Tylenol brand decongestant and allergy medicines.
Here is a link.
Many cold meds aren't what they used to be
Robert Cohen, Newhouse News Service
Last update: November 24, 2006 - 8:46 PM
WASHINGTON - Nose stuffed up? Grabbing a decongestant from the drugstore or supermarket shelf may not provide the relief it did just weeks ago.
Makers of dozens of nonprescription oral nasal decongestants sold under familiar brand names such as Dimetapp, Sudafed, Tylenol, Vicks, Benadryl and Triaminic recently changed an active ingredient in some of their products to avoid a new federal mandate that the meds be sold behind the counter.
Now a number of pharmaceutical experts and one influential member of Congress are questioning whether replacing pseudoephedrine -- which is subject to sales restrictions -- with the ingredient phenylephrine has made many of the over-the-counter remedies largely useless in clearing up nasal congestion.
"At the maximum 10 milligram dose, phenylephrine is no more effective than a placebo. It's like shooting blanks," said Leslie Hendeles, a research pharmacist at the University of Florida.
John Colazzi, dean of Rutgers University's Ernest Mario School of Pharmacy, said phenylephrine had not been widely used for years because of its "limited effectiveness."The impression I have is that phenylephrine isn't that good of a nasal decongestant, and not as effective as pseudoephedrine," Colazzi said.
Drugmakers began switching to phenylephrine as an active ingredient for some of their nonprescription decongestants and allergy medicines because of the Combat Methamphetamine Act, which was signed into law in March by President Bush and went into effect on Sept. 30.
Under that law, any medicines that can be used in the illegal production of methamphetamine, including pseudoephedrine, have to be kept behind store counters, with customers showing an ID, signing a log book and facing a limit on how much they can purchase.
Phenylephrine was the only alternative for drugmakers wanting to keep their products on open store shelves; a third ingredient, phenylpropanolamine, or PPA, was voluntarily withdrawn in 2000 because strokes were associated with its use.
Rep. Henry Waxman, D-Calif., a longtime pharmaceutical industry watchdog, has twice asked the FDA to convene an expert advisory committee to review all the available data on phenylephrine because of the concerns about its effectiveness, but his pleas have been rejected.
Waxman recently renewed his request to the FDA, citing a newly completed small clinical trial conducted by drugmaker Schering-Plough.
That study of 38 subjects compared phenylephrine with a placebo and pseudoephedrine. It found phenylephrine was "not significantly different from placebo in decreasing nasal congestion" while pseudoephedrine was "significantly more effective."
Schering spokeswoman Julie Lux said the company decided not to reformulate its popular Claritin-D allergy product after reviewing its clinical study and because of "the strong clinical data on the proven long-lasting effectiveness of our key ingredient pseudoephedrine."
Waxman said Schering-Plough's decision not to switch ingredients and to keep Claritin-D behind the counter could mean a loss of market share.
Many drugmakers have chosen a dual route -- keeping their established name-brand products with pseudoephedrine on the market and available behind the counter, while offering a second reformulated version containing phenylephrine that can be displayed on open store shelves.
Suman Wason of the Wyeth consumer health medical affairs group said his company has chosen the two-track approach with its Dimetapp and Robitussin cold remedies.
Michael Beckerich of McNeil Consumer Health Care, a subsidiary of Johnson & Johnson, said his company will take the same approach with its Tylenol brand decongestant and allergy medicines.