BusinessFDA votes on OTC meds Benadryl, Sinex

FDA votes on OTC meds Benadryl, Sinex

On Tuesday, a Food and Drug Administration (FDA) advisory panel concluded that one of the key ingredients in many over-the-counter (OTC) decongestant medications doesn’t work.

The ingredient, phenylephrine, is used in medications like Sudafed PE, Sinex, and Benadryl Allergy Plus, which are all OTC pills. The FDA brought forth enough evidence to prove that the ingredient does little to relieve sinus congestion when taken orally. Phenylephrine is also used in some liquid and spray decongestants. That form of medication wasn’t part of the examination.

Fast Company has reached out to Benadryl and Sudafed for comment on the FDA’s conclusion, and will update this post if we hear back.

A unanimous vote by the FDA advisory panel determined that oral formulations of phenylephrine are ineffective, and as cold and flu season looms, the findings are sure to disrupt the market in a major way. That’s especially true because phenylephrine is the most popular oral decongestant in the United States. According to data presented on Monday by FDA officials, products containing the ingredient generated almost $1.8 billion in sales last year.

Still, this isn’t the first time we’ve heard about the ineffectiveness of the ingredient. Many scientists, pharmacists, and other experts have been pushing for phenylephrine’s removal from shelves for years. In 2022, the American Academy of Allergy, Asthma, and Immunology supported a citizens’ petition to remove its over-the-counter status, citing its poor ability to restrict blood vessels of the nasal passages. And in 2007, the same FDA committee met to examine the drug’s effectiveness. At the time, the committee called for more studies.

During the trial, scientists proved that when taken orally, phenylephrine has the same effect as a placebo. That was true even at higher doses. The FDA’s vote suggests that companies that sell the drug could be forced to pull the products or reformulate them into more effective versions.

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