As frustrating as colds and allergies may be to those who suffer from them, it is even more concerning to learn that popular remedies we rely on may not actually be effective in relieving our stuffy noses. The U.S. Food and Drug Administration (FDA) is currently discussing the possibility of removing the designation “generally recognized as safe and effective” (GRASE) for the common ingredient known as phenylephrine in popular nasal decongestants. An advisory panel to the agency found that the drug is ineffective when taken orally. The GRASE designation allows manufacturers to market phenylephrine without filing an FDA application.
This impending decision could disrupt the market for the cold and allergy industry, which generated nearly $1.8 billion in sales last year. Companies may be required to remove oral decongestants containing phenylephrine from shelves or reformulate them without the ingredient. It turns out that the popular remedies we buy at the drugstore, thinking they are treating our cold and allergy symptoms, may actually be ineffective at relieving our stuffy noses. According to the FDA’s recent announcement, there is new data available on the effectiveness of oral phenylephrine as a nasal decongestant, which prompted them to seek input from an advisory committee.
Phenylephrine is a common ingredient in over-the-counter (OTC) cold and allergy medications such as Dayquil, Mucinex, Benadryl Allergy Plus Congestion, and Sudafed PE. After reviewing the scientific data presented, the 16-member committee unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant.
Interestingly, the FDA previously reviewed this topic in 2007 and decided to keep the drug on the market despite a review that year finding insufficient evidence of its effectiveness as a decongestant. However, since then, several large placebo-controlled trials have provided more definitive research showing that there is no evidence that standard and higher doses of oral phenylephrine relieve nasal congestion.
So how does phenylephrine work? When we have a cold, our immune system sends white blood cells to fight the infection in our nasal passages, which can lead to a stuffy nose and mucus production. Phenylephrine works by constricting the blood vessels in our nose and sinuses, thereby reducing swelling and congestion. It is essential to note that one adverse side effect of phenylephrine is an increase in blood pressure at higher doses. However, when swallowed, phenylephrine is ineffective since most of the dose is inactivated and doesn’t enter the bloodstream.
According to Leslie Hendeles, a professor emeritus in the College of Pharmacy at the University of Florida, phenylephrine is effective when administered through alternative routes such as a topical nasal spray, eye drops to dilate pupils, or intravenous administration during surgeries to reverse low blood pressure. By spraying phenylephrine directly into the nose, it produces about a million times more drug in the nasal mucosa compared to swallowing it.
In 2015, Hendeles and another colleague petitioned the FDA to reevaluate the decision on allowing oral phenylephrine in nasal decongestants, which ultimately led to the current advisory meeting. Following the committee’s recommendation, the FDA will now review various cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter use. If the FDA determines that oral phenylephrine is no longer considered GRASE under the conditions of use, they will issue a proposed order to remove it as an active ingredient. However, during this process, the marketing status of oral phenylephrine will not change, and people will have the opportunity to comment on the proposed order.
Although the Consumer Healthcare Products Association (CHPA) expressed its disappointment with the advisory committee’s non-binding recommendation, caution should be exercised before the FDA makes a final decision. They emphasize the numerous clinical trials and previous regulatory determinations that have affirmed oral phenylephrine as a safe and effective decongestant. According to Scott Melville, CHPA president and CEO, there could be significantly negative unintended consequences associated with any potential change in oral phenylephrine’s regulatory status.
At this time, the FDA has no further information regarding the timing of any decision following the advisory committee meeting.
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