What to take for a cold after FDA says common decongestant doesn’t work
The most popular nasal decongestant on U.S. pharmacy shelves may not be there much longer
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Your support makes all the difference.The Food and Drug Administration (FDA) has proposed that a common decongestant, Phenylephrine, isn’t actually effective, leaving consumers wondering about the best methods to treat their colds.
In November, the FDA announced that it was proposing to remove oral phenylephrine as an ingredient in over-the-counter medicine for nasal congestion.
Phenylephrine is used in popular versions of Sudafed, Dayquil, and other medications. It has been sold for more than 75 years, predating the agency’s own regulations on drug effectiveness.
“It is the FDA’s role to ensure that drugs are safe and effective,” Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”
The FDA notes the proposed order is not based on safety concerns, and that the presence of oral phenylephrine in these medicines does not affect how other active ingredients treat symptoms. In addition, its action is only related to orally administered phenylephrine and not the nasal spray form.
So, what are some alternatives to help congestion? Consumers who still want to take pills or syrups for relief will probably need to head to the pharmacy counter — where the pseudoephedrine-containing versions of Sudafed, Claritin D, and other products remain available without a prescription. Purchasers need to provide a photo ID.
Beyond those products, most of the other options are over-the-counter nasal sprays or solutions. Saline drops and rinses are a quick way to clear mucus from the nose.
For long-term relief from seasonal stuffiness, itching, and sneezing, many doctors recommend nasal steroids, sold as Flonase, Nasacort, and Rhinocort.
“These medicines are by far the most effective daily treatment for nasal congestion and stuffiness,” Dr. Brian Schroer of the Cleveland Clinic said. “The biggest issue is they’re not great when used on an as-needed basis.”
Nasal steroids generally have to be used daily to be highly effective. For short-term relief, patients can try antihistamine sprays, such as Astepro, which are faster-acting.
FDA’s request to remove phenylephrine from cold medicines is a win for skeptics, including researchers at the University of Florida who petitioned the FDA to revisit the drug’s use in 2007 and again in 2015. Doctors say Americans will be better off without phenylephrine, which is often combined with other medicines to treat cold, flu, fever and allergies.
The experts who challenged the drug’s effectiveness say it's quickly broken down and rendered ineffective when it hits the stomach.
“This is a good drug, but not when it’s swallowed,” said Leslie Hendeles, professor emeritus at the University of Florida's College of Pharmacy, where he co-authored several papers on the ingredient. “It’s inactivated in the gut and doesn’t get into the bloodstream, so it can’t get to the nose.”
When Hendeles and his colleagues first petitioned the FDA on phenylephrine, they suggested a higher dose might be effective. Subsequent studies showed that even doses 400 percent higher than those currently recommended don’t treat stuffiness.
However, oral phenylephrine medicines will still be with us for a while. Government regulators must follow a public, multistep process to remove the ingredient from FDA’s list of drugs approved for over-the-counter decongestants.
For six months, the FDA must take comments on its proposal, including from consumers and companies. Then, the FDA must review the feedback before writing a final order. Even after that decision is finalized, companies will likely have a year or more to remove or reformulate products.
Additional reporting by the AP