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Pharmacists Rap New Version of Decongestants

They say the active ingredient doesn't work

FRIDAY, July 28, 2006 (HealthDay News) -- Starting in late September, Sudafed and similar cold medications will only be available from behind pharmacy counters because their active ingredient can be used to make the street drug methamphetamine.

So, consumers may be tempted to try a new type of drug that will be easier to buy. But two pharmaceutical researchers contend there's a big problem with the new nasal decongestants: They don't work.

In a peer-reviewed letter released this week to the editor of the Journal of Allergy and Clinical Immunology, University of Florida researchers argued that there's little evidence to suggest that the active ingredient in the new Sudafed PE or similar medications will do anything to relieve a stuffy nose.

But Pfizer, the maker of Sudafed PE, stands by its product and says it's effective. "We've seen some positive results with how consumers are responding to it," said company spokeswoman Erica Johnson.

Under the USA Patriot Act, any drug containing pseudoephedrine must be kept under lock and key starting Sept. 30. That means consumers won't be able to find the drugs on store shelves; instead, they'll have to ask a store employee for the drug, show identification, and sign a sales log. Some states, such as Oregon, are adopting even tougher laws, requiring prescriptions for drugs containing pseudoephedrine.

The law is designed to make it more difficult for people to get their hands on pseudoephedrine to make methamphetamine.

But according to University of Florida pharmacist Dr. Leslie Hendeles, what the law really does "is perhaps provide the prosecutor with a trail if you're caught, but it doesn't prevent anyone from getting a large quantity and making meth out of it."

If consumers want to avoid the hassle of speaking to a pharmacist and signing a logbook to buy a nasal decongestant like Sudafed or Claritin-D, they have other options. One of those options is Sudafed PE, whose active ingredient -- phenylephrine -- can't be used to make methamphetamine. Sudafed PE has been on the market since February 2005.

In their letter, Hendeles and colleague Dr. Randy Hatton contended that when the U.S. Food and Drug Administration approved the use of phenylephrine in 1976, the agency was only able to find four studies that suggested it worked at a dose of 10 milligrams, the size of Sudafed PE pills. Two of those studies were sponsored by drug companies, and all were unpublished and not reviewed by peers, Hendeles said.

Seven other studies, according to the authors, found that phenylephrine didn't work better than a placebo.

"It does nothing," Hendeles said. "Clearly the 10 milligram (dose) does not work."

According to Hendeles, it seems that phenylephrine is simply not absorbed well by the body when taken in pill form. In a nasal spray, by contrast, phenylephrine works fine, he said.

Hendeles and Hatton wrote that it's unclear if larger oral doses of phenylephrine would work better.

Johnson, the Pfizer spokeswoman, said five studies showed that phenylephrine works in pill form. "We're pleased that people are recognizing there are alternatives, they have a choice," she said.

So, what should you do if you have a cold and need to unstuff your nose?

There aren't many good answers, since there's actually little research suggesting that any cold remedies are effective, including the ingredient in the original Sudafed, said Dr. Bruce Barrett, associate professor of family medicine, at the University of Wisconsin Medical School at Madison.

To make matters worse, "none of the approved cold treatments is clearly beneficial with benefits outweighing risks," he said.

Nasal steroids do work in people with allergies, Barrett said. Hendeles recommended decongestant nasal sprays for people with colds.

More information

Learn more about cold and flu from the American Lung Association.

SOURCES: Erica Johnson, spokeswoman, Pfizer Inc., Morris Plains, N.J.; Leslie Hendeles, Pharm.D., professor of pharmacy and pediatrics, University of Florida, Gainesville; Bruce Barrett, M.D., Ph.D., associate professor of family medicine, University of Wisconsin, Madison; July 2006, Journal of Allergy and Clinical Immunology
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