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Popular OTC Cold Medicine Doesn’t Work, Study Finds

The oral decongestant phenylephrine is not effective at the FDA-approved amount

Nonprescription decongestants are among the most popular over-the-counter drugs, but according to University of Florida researchers, the oral decongestant phenylephrine simply does not work at the FDA-approved amount found in many nonprescription brands. It may not even work at much higher doses, they said.

According to Forbes, the study of 539 adults lasted one week and failed to find a dose of phenylephrine within the 10-mg to 40-mg range that was more effective than a placebo in relieving nasal congestion. The approved FDA dose is 10 mg every four hours for “temporary relief of nasal congestion.” Consequently, the Florida researchers are asking the FDA to remove oral phenylephrine from the market.

“We think the evidence supports that phenylephrine’s status as a safe and effective over-the-counter product should be changed,” said Randy Hatton, PharmD, a clinical professor of pharmacotherapy and translational research. “We are looking out for the consumer, and he or she needs to know that science says that oral phenylephrine does not work for the majority of people.”

Back before methamphetamine cooks started buying up nonprescription decongestants to brew crank, all of us were able to buy effective decongestants right off the store shelf without a problem. The active ingredient in those medications, coveted by meth smurfers and cold sufferers alike, was pseudoephedrine. But then federal legislation was enacted to restrict the sale of pseudoephedrine-containing products (the Combat Methamphetamine Epidemic Act of 2005) and they were moved behind the pharmacy counter. You can still buy them, assuming you know they’re available, by presenting identification and signing a statement saying you’re not buying the drugs for nefarious purposes.

To fill the store-shelf void, drug companies substituted the already-FDA approved ingredient phenylephrine for pseudoephedrine. Several studies testing phenylephrine against a placebo produced results that question its effectiveness, and eventually the FDA started to listen to critics in the research community asking for greater scrutiny. The latest research adds a boldface exclamation point to the criticism. Whether the FDA will act on the findings is another matter.

The number of brands containing phenylephrine is too large to list, but the majority of on-the-shelf oral decongestants list it as an active ingredient, including many multisymptom products. Instead of buying products containing phenylephrine, the researchers suggest cold and allergy sufferers choose a pseudoephedrine product from behind the counter or nasal steroids for allergic rhinitis.

Source: Forbes, October 27, 2015.

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