Big changes are coming to the cold and cough medicine aisle at pharmacies across USA. Regulators in that country have decided to act after determining that the main decongestant present in hundreds of medicines over-the-counter does not fulfill its function of relieving nasal congestion, so now they are seeking to eliminate it gradually, which would give a very important turn in the offer of over-the-counter treatments.
Phenylephrine is used in popular versions of Sudafed, Dayquil and other medications, but experts have long questioned its effectiveness. Last month, the Food and Drug Administration (FDA) formally proposed revoking its use in pills and liquid solutions, beginning a process that will likely force drugmakers to recall or reformulate products.
For consumers, it will likely mean looking for alternatives.
Doctors say people will be better off without phenylephrine, which is often combined with other medications to treat colds, flu, fever and allergies.
“Today, people walk into the pharmacy and see 55,000 medications on the shelf and choose one that is definitely not going to work,” said Dr. Brian Schroer of the Cleveland Clinic.
Federal advisers to the FDA noted last year that oral medications with phenylephrine have not been shown to relieve congestion.
Experts reviewed several recent, large studies that indicate phenylephrine is no better than a placebo for clearing nasal passages. They also reviewed studies from the 1960s and 1970s that supported the drug’s initial use, finding numerous flaws and questionable data.
The panel’s opinion only applied to phenylephrine in oral medications, which account for approximately $1.8 billion in annual sales in the United States. The medication is still considered effective in nasal sprays, although these are much less popular.
What are some alternatives for congestion?
Consumers who still want to take relief pills or syrups will probably need to head to the pharmacy counter, where versions that contain pseudoephedrine from Sudafed, Claritin D and other products are still available without a prescription.
Saline drops and rinses are a quick way to clear mucus from your nose. For long-term relief from seasonal congestion, itching and sneezing, many doctors recommend nasal steroids.
“These medications are by far the most effective daily treatment for nasal congestion and congestion,” Schroer said. “The biggest problem is that they are not great because of the frequency of use.”
Nasal steroids must be used daily to be highly effective. For short-term relief, patients can try antihistamine sprays, such as Astepro, which work faster.
Oral medications with phenylephrine will be with us for a while.
Regulators must follow a public, multi-step process to remove the ingredient from the FDA’s approved drug list for over-the-counter decongestants.
For six months, the FDA must receive comments on its proposal, including from consumers and businesses. The agency must then review the comments before writing a final order. Even after that decision is finalized, companies will likely have a year or more to eliminate or reformulate products.
Drugmakers could further delay the process by requesting additional FDA hearings.
For now, the Consumer Healthcare Products Association, which represents drug makers, wants the products to remain available, arguing that Americans deserve “the choice to choose the products they prefer for self-care.”
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