With the Decongestant SNAFU, the FDA Tries Something New

It’s easy to understand how a medicine like phenylephrine got onto pharmacy shelves in the first place. The common decongestant, used most often as an ingredient in multidrug cold medications like DayQuil and Sudafed PE, was initially designated as “safe and effective” by the Food and Drug Administration (FDA) in 1976, when the agency was newly—and less stringently than today—greenlighting drugs that had been on the market for years before the agency had established any efficacy standards. After a full review of 14 studies (12 unpublished and two published) from pharmaceutical companies—a fair body of evidence for the time—the panel of experts assigned to evaluate over-the-counter allergy medications ruled that phenylephrine was effective. [time-brightcove not-tgx=”true”] Except phenylephrine has never worked. What’s puzzling, then, is how it stayed on those shelves for 50 years without a challenge. That changed on Sep. 12, when a different FDA advisory committee looking in part at that same early research voted 16-0 that the common oral form of phenylephrine is ineffective, opening the door for products claiming it works as a decongestant to be pulled from stores altogether. Though a final decision by agency authorities could take months and face legal challenges, the panel vote alone could be a death blow to the medication, which appears in products that together account for nearly $1.8 billion in U.S. spending...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized healthscienceclimate Source Type: news