The FDA is reevaluating the drug phenylephrine, which is an ingredient found in many common cold meds used for congestion.
Hendeles and Hatton aren't the only ones pushing back against oral phenylephrine., MD, an allergist and immunologist at Allergy & Asthma Associates of Murray Hill in New York City,"Sudafed does work for a few days, but not in the long run," Parikh said., a primary care physician at Massachusetts General Hospital, told CBS News that she does not advise its use for the same reason.
"When my patients ask for over-the-counter medications for cold symptoms, I tell them to avoid buying oral meds that have phenylephrine," she said. According to Armand, allowing people to use medications that contain oral phenylephrine is not only concerning because they don't work. These meds are also harmful because the drugs may cause side effects like headaches, insomnia, and nervousness.posted days before the meeting, the FDA acknowledged that it has already changed its position of the effectiveness of oral phenylephrine.
If the NDAC votes to agree that it is ineffective, the FDA may decide to revoke phenylephrine's GRASE status. The agency isto follow the advice of independent advisory committees but usually does, according to Axios. A lack of GRASE status would make it harder for manufacturers to include phenylephrine in OTC products, and could lead to medications like Sudafed PE, DayQuil Cold and Flu, and Tylenol Cold being pulled from store shelves altogether.
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