As cash strapped consumers head to the pharmacy this cold and flu season, a stunning revelation had been disclosed, a long time popular over the counter decongestant doesn't actually work and will be recalled.
A panel of experts reviewed several recent, large studies indicating that phenylephrine, used in popular versions of Sudafed, Dayquil and other medications, was no better than a placebo at clearing nasal congestion. They also revisited studies from the 1960s and 1970s that supported the drug’s initial use, finding numerous flaws and questionable data. The panel of federal advisers voted unanimously that oral phenylephrine medications were ineffective.
The panel’s opinion only applied to phenylephrine in oral medications, which account for roughly $1.8 billion in annual U.S. sales. The drug is still considered effective in nasal sprays, though those are much less popular. Phenylephrine-based nasal sprays will remain on pharmacy shelves.
It’s a win for skeptical academics, including researchers at the University of Florida who petitioned the Food and Drug Administration to revisit the drug's use in 2007 and again in 2015. “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 phenylephrine. “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 the drug, they suggested a higher dose might be effective. However subsequent studies showed that even doses 400% higher than those currently recommended still don’t treat congestion.
The FDA has now formally proposed revoking the use of phenylephrine in pills and liquid solutions, initiating a process that's likely to force pharmaceutical manufacturers to remove or reformulate their products. For consumers it will mean switching to alternatives, including an older decongestant that was moved behind the pharmacy counter nearly 20 years ago.
Phenylephrine wasn’t always the top choice for over the counter cold and allergy products. Many were originally formulated with a different drug that actually works, pseudoephedrine.
Then, in 2006, a law required pharmacies to move pseudoephedrine products behind the counter, citing their potential to be processed into methamphetamine. Companies such as Johnson & Johnson and Bayer reformulated their products to keep them readily available on store shelves, labelingl many of them as “PE” versions of the familiar brand names.
At the same time, the federal government also banned the sale of the herb ma huang, a highly effective natural decongestant. This caused a popular herbal tea Sold as “Breathe Right” to change their product.
Doctors say Americans will be better off without phenylephrine, which is often combined with other medicines to treat cold, flu, fever and allergies.“People walk into the drugstore today and see 55,000 medicines on the shelf and they pick one that is definitely not going to work,” said Dr. Brian Schroer of the Cleveland Clinic. “You take away that option and it will be easier for them to self-direct toward products that really will help them.”
So what will help them? Well, consumers who still want to take pills or syrups for congestion relief will probably need to head to the pharmacy counter. That's where the versions of Sudafed, Claritin D and other products that contain pseudoephedrine remain available without a prescription. Purchasers will need to provide a photo ID.
Other short term options are over-the-counter nasal sprays or solutions. For long term relief from seasonal stuffiness, itching and sneezing, many doctors recommend nasal steroids, sold as Flonase, Nasacort and Rhinocort.
Oral phenylephrine medicines will still be on the shelf for a while, because government regulators must follow a public, multi-step process to remove the ingredient from the 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.