CNN –
Phenylephrine, a popular ingredient in many over-the-counter allergy and cold medications, is ineffective in tablet form, an independent advisory committee to the U.S. Food and Drug Administration found Tuesday.
Phenylephrine is the main ingredient in products such as Benadryl Allergy Plus Congestion, Sudafed PE, and Vicks Sinex.
The ingredient is considered safe to use; that wasn’t up for debate. But many doctors have doubted the effectiveness of phenylephrine for years. These products generated nearly $1.8 billion in sales last year alone, according to FDA data presented to the Non-Prescription Drug Advisory Committee on Monday during the committee’s two-day meeting.
On Tuesday, the committee voted “no” to the specific question: “Do the current scientific data presented support that monographic dosing of oral phenylephrine is effective as a nasal decongestant?”
The vote was unanimous among the 16 members, and the committee agreed that the issue did not need to be investigated further.
“We really shouldn’t put products on the market that aren’t effective,” said committee member Dr. Diane Ginsburg from the University of Texas at Austin College of Pharmacy.
The FDA told the committee it would consider their advice, but did not provide a timeline. If the agency decides to reclassify phenylephrine from GRASE (Generally Recognized as Safe and Effective), stakeholders would have the opportunity to comment on the proposed change and provide additional data. During this process, companies would still be allowed to market products containing phenylephrine. However, if the FDA agrees with the committee, companies may have to remove products containing phenylephrine from shelves or reformulate them.
The agency approved phenylephrine for over-the-counter use in the 1970s, but it became even more common after 2005 when legislation restricted access to over-the-counter drugs containing a similar decongestant called pseudoephedrine.
In 2007, the FDA committee examined the scientific evidence available at the time and came to a different conclusion: It agreed that phenylephrine “may be effective” but also called for more research.
Since then, studies, including three large clinical trials, have shown that the orally administered ingredient does not act as a decongestant at its typical dosage.
The committee also examined other research supporting its over-the-counter use. The FDA found that these study results were inconsistent and many did not meet modern scientific standards.
The committee did not address the issue of nasal sprays that use phenylephrine because studies appear to show effectiveness, at least temporarily.
According to the American Academy of Allergy, Asthma and Immunology, phenylephrine is considered the most common ingredient in over-the-counter oral nasal and sinus products. Last year, the group supported a citizen petition aimed at revoking the drug’s over-the-counter status.
Phenylephrine works by temporarily reducing the swelling of the blood vessels in the nasal passages. A respiratory infection or allergies cause the body to send white blood cells into the nose, throat, and sinuses, causing swelling of the nasal lining and the formation of mucus. Decongestants constrict the blood vessels in the sinuses and nose, reducing swelling and aiding fluid drainage.
Some scientists say that phenylephrine in pill form is absorbed by the gut and metabolized so well that only a tiny portion enters the bloodstream, where it is needed to reach the nose, according to the citizen petition asking the FDA , they withdraw the drug from the shelves. A citizen petition is an opportunity for industry, consumer groups, or individuals to petition the FDA to change regulations or take other administrative action.
In discussing Tuesday’s vote, the committee agreed that safety was not the reason the FDA was taking action on these products. Rather, they advised the FDA to take action because the pills were essentially a waste of money and over-the-counter medications can help people with colds or allergies.
“It’s amazing how much money is spent on something that really has no effectiveness,” said committee member Dr. William Fig, clinical pharmacologist and researcher at the National Cancer Institute.
Every year, many Americans seek relief with over-the-counter cold and allergy medications. According to the American Lung Association, about 60 million people in the United States suffer from allergies, and adults get two to four colds per year, totaling 1 billion colds per year.
Studies show that colds and allergies can significantly impact the quality of life. In addition to a runny nose and cough, allergies and colds can also worsen asthma and lead to sleep disorders.
Changing the name of phenylephrine could be costly for manufacturers. The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter drugs and dietary supplements as well as consumer medical devices, opposes the change.
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The association said Tuesday that it was disappointed with the committee’s decision and called on the FDA to “consider the totality of evidence regarding this long-standing OTC ingredient, as well as the significant negative unintended consequences, before making regulatory changes.” “. associated with a possible change in the regulatory status of oral PN.”
She told the FDA committee that her surveys show that people prefer their decongestants in tablet form to nasal spray. If these drugs were no longer available, this could pose a real burden to consumers, the association said.
On Tuesday, the FDA committee said that if the FDA decides to reclassify phenylephrine and it disappears from the market, the agency will need to educate the public about why some popular allergy and cold medicines will no longer be available.
If phenylephrine is no longer available, there are several other over-the-counter options, including nasal spray antihistamines, nasal corticosteroids and nasal saline products, and pseudoephedrine tablets.
Products containing pseudoephedrine are considered over-the-counter but remain behind the counter because pseudoephedrine can be used in large quantities to produce the illegal drug methamphetamine.
CNN’s Meg Tirrell contributed to this report.