Those over-the-counter decongestants you probably have in your medicine cabinet aren't going to help your cold or allergies, a U.S. Food and Drug Administration panel ruled Tuesday.
The panel unanimously agreed that oral formulations of phenylephrine, the most common active ingredient in many over-the-counter cold medicines, is ineffective, meaning drugs like Dayquil, Mucinex, Sudafed PE, Allegra and Benadryl cold and flu remedies are thereby ineffective at relieving congestion and could be taken off the market.
Phenylephrine has been thought to work by reducing swelling of blood vessels in the nose and ears, but after a two-day review, the FDA panel found neither the standard oral OTC dose or even a high dose were effective at actually reaching the nose to relieve congestion.
The drug became the main ingredient in OTC decongestants after medicines with pseudoephedrine were moved behind the pharmacy counter due to the Combat Methamphetamine Epidemic Act of 2005, which aimed to regulate OTC drugs that could be used in manufacturing illegal drugs. This prompted most companies to reformulate away from the older ingredient and use phenylephrine instead to keep their oral products on the shelves.
Last year, at least 242 million oral, phenylephrine-led cold and allergy drugs were sold, making up a nearly $1.8 billion industry. But the FDA's panel's conclusion could change the future of many of these oral decongestant products.
Though the panel's evidence isn't a final call, its ruling strongly suggests the FDA pull approval for oral drugs containing phenylephrine — more specifically, the FDA would decide whether to revoke their designation as "generally recognized as safe and effective," or GRASE.
Phenylephrine is still recognized as safe, but without efficacy, the drug can't fulfill the full GRASE designation, which allows drugmakers to include an ingredient in OTC products without filing an FDA application.
If the FDA does decide to pull the designation, which it usually does, drug companies like Johnson & Johnson and Bayer would be forced to reformulate their products or remove them from store shelves.
This would likely push those who need decongestants to use nasal sprays instead of pills, or they would have to switch to behind-the-counter pseudoephedrine drugs.
This isn't the first time the agency has evaluated phenylephrine's efficacy.
In 2007, multiple groups of experts concluded phenylephrine products weren't effective, and since then, there have also been three large clinical trials concluding the same. But none have prompted FDA action until the newest study, which reflected new insights into how quickly the drug was metabolized orally, leaving only trace amounts to actually travel to nasal passages.
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