![]() But it raises questions how something like this could happen, when you look back at the history of drug approvals and how long it takes to change things that have been approved. I don’t think I’ve recommended this product over the past 15 years in practice. If you go back and look at guidelines from decades ago, there was no evidence that it worked, so this decision isn’t a surprise. Platt: This medication, phenylephrine, is lumped into the category of a decongestant. ![]() Q &A with Michael Platt The Brink: Was this news of phenylephrine being ineffective surprising to you? So, why has this decongestant been available for so many decades, despite experts questioning its effectiveness? And what should people searching for ways to relieve a stuffy nose do? Nasal and sinus researcher and physician Michael Platt, a Boston University Chobanian & Avedisian School of Medicine associate professor of otolaryngology–head and neck surgery, spoke with The Brink about what this news means for doctors and consumers. But modern studies have found that taking the medication orally is no more effective than a placebo. When the FDA toughened its approach in the 1970s, the ingredient was basically grandfathered into the agency’s new drug approval list. Phenylephrine has been available for over 60 years, which means it didn’t undergo the rigorous scrutiny applied to newer medicines. Now that the panel has voted, the FDA has to decide whether or not to ban the ingredient, which would involve pulling products from store shelves. ![]() Phenylephrine is in at least 250 products that were collectively worth about $1.8 billion in sales last year, including cold, flu, and allergy products from brands like Tylenol, Mucinex, Benadryl, Sudafed, NyQuil, and others. The news could have a big impact on your medicine cabinet. The panel said that the popular medicine is ineffective when taken orally-no better than a sugar pill. An advisory panel to the US Food and Drug Administration (FDA) has unanimously agreed that a common ingredient found in nasal decongestants, called phenylephrine, is a dud.
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