A U.S. Food and Drug Administration panel ruled Tuesday that those over-the-counter decongestants in your medicine cabinet won’t help your cold or allergies.
Panel There was unanimous agreement that oral formulations of phenylephrine, the most common active ingredient in many over-the-counter cold medications, are ineffective, meaning medications such as Dayquil, Mucinex, Sudafed PE, Allegra, and Benadryl cold and flu treatments. Are ineffective in relieving congestion and may be removed from the market.
Phenylephrine is thought to work by reducing the swelling of blood vessels in the nose and ears, but after a two-day review, an FDA panel found that neither standard oral OTC doses or even higher doses Was really effective in reaching the nose for relief. Crowd.
The drug became the main ingredient in OTC decongestants after drugs containing pseudoephedrine were moved to the back of pharmacy counters due to the Combat Methamphetamine Epidemic Act of 2005, which aimed to regulate OTC drugs that could be used in the manufacture of illegal drugs. This led most companies to put their oral products on the shelves to move away from the older ingredient and use phenylephrine instead.
Last year, at least 242 million oral, phenylephrine-based cold and allergy medications were sold, creating a roughly $1.8 billion industry. But the FDA panel’s findings could change the future of many of these oral decongestant products.
Although the panel’s evidence is not a final decision, its decision strongly suggests that the FDA withdraw approval for oral medications containing phenylephrine – more specifically, the FDA will decide whether their designation is “generally safe and effective.” Whether recognized as” or canceled as GRASE.
Phenylephrine is still considered safe, but without efficacy, the drug cannot meet full GRASE designation, which allows drug manufacturers to include an ingredient in OTC products without filing an FDA application.
If the FDA decides to remove the designation, as it usually does, drug companies like Johnson & Johnson and Bayer will be forced to reformulate their products or remove them from store shelves.
This would likely lead people who need decongestants to use nasal sprays instead of pills, or to switch to over-the-counter pseudoephedrine medications.
This is not the first time the agency has evaluated the efficacy of phenylephrine.
In 2007, several groups of experts concluded that phenylephrine products were not effective, and since then, there have been three large clinical trials that also concluded the same. But none prompted FDA action until the latest study, which reflected new insights into how rapidly the drug was metabolized orally, allowing only trace amounts to actually get into the nasal passages. Only this was left.