FDA panel to re-evaluate common over-the-counter decongestant criticized as 'useless'

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FDA panel to re-evaluate common over-the-counter decongestant criticized as 'useless'
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For years, doctors and pharmacists have said the oral decongestant phenylephrine, found in drugs including Sudafed PE, isn't actually effective.

to re-evaluate the effectiveness of the ingredient, phenylephrine, which is found in many decongestants.

Phenylephrine was approved by the FDA for over-the-counter use in the 1970s. It comes in several forms, including liquids, pills and nasal sprays and is found in drugs including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion. The stakes are high, experts say, because a committee vote declaring phenylephrine ineffective as an oral decongestant could push the FDA to revoke the drug’s over-the-counter designation as “Generally Recognized as Safe and Effective,” and potentially lead to it being pulled from stores shelves. The, typically used for older drugs, allows drugmakers to include an ingredient in over-the-counter products without the need to file an FDA application.

Feeling out of the loop? We'll catch you up on the Chicago news you need to know. Sign up for the weeklyQuestions about the drug’s effectiveness go as far back as 2007, when a group of pharmacists filed a Citizen Petition to pull the drug from store shelves because of evidence that it was no better than a placebo.

The pharmacists cited studies that found when taken orally, a large portion of phenylephrine is metabolized in the gut and liver before it reaches the bloodstream. This means that a very small amount of the drug actually reaches the nose to

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