(CNN) — Phenylephrine, a common ingredient in many over-the-counter cold and allergy medications, is not effective in tablet form, an independent advisory committee to the U.S. Food and Drug Administration agreed Tuesday. (FDA abbreviation and English)).
Phenylephrine is the main ingredient used in products such as Benadryl Allergy Plus Congestion, Sudafed PE and Vicks Sinex.
This ingredient is considered safe to use; this is not controversial. But for years many doctors have questioned the effectiveness of phenylephrine. The products generated nearly $1.8 billion in sales last year alone, according to data presented to the FDA Monday at a two-day meeting of the Over-the-Counter Drugs Advisory Committee.
On Tuesday, the committee voted against the following specific question: “Does current scientific data support the effectiveness of monograph doses of oral phenylephrine as a nasal decongestant?”
The vote was unanimous among 16 members, with the committee agreeing that the issue did not require further study.
“We really shouldn’t be putting products on the market that don’t work,” said committee member Dr. Diane Ginsburg of the University of Texas at Austin School of Pharmacy.
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In this 2006 photo, the nasal decongestant Sudafed PE is displayed on a shelf at a Walgreens store in Chicago, Illinois. (Photo credit: Tim Boyle/Getty Images/File)
The FDA told the committee it would consider their recommendations but gave no timetable. If the agency decides to reclassify phenylephrine from Generally Recognized as Safe and Effective (GRASE), interested parties will have an opportunity to comment on the proposed changes and provide any additional data. During this process, companies can still sell products containing phenylephrine. But if the FDA agrees with the committee’s opinion, the company may be required to remove phenylephrine products from store shelves or reformulate them.
The agency approved phenylephrine for over-the-counter use in the 1970s, but it became more common after 2005, when legislation restricted the use of over-the-counter medications using a similar decongestant ingredient (pseudoephedrine).
In 2007, an FDA committee reviewed the science available at the time and came to a different conclusion, agreeing that phenylephrine “may be effective” but also calling for more research.
Research conducted since then, including three large clinical trials, has shown that the oral ingredient is not effective as a decongestant at its typical doses.
The committee also reviewed other studies used to support its over-the-counter use. The FDA found the results of these studies to be inconsistent and many did not meet modern scientific standards.
The committee did not address the issue of nasal spray products that use phenylephrine, which studies appear to show are at least temporarily effective.
Phenylephrine is considered the most common ingredient in over-the-counter oral, nasal and sinus products, according to the American Academy of Allergy, Asthma and Immunology. Last year, the group supported a citizen petition calling for the OTC drug’s status to be eliminated.
Phenylephrine works by temporarily reducing inflammation of the blood vessels in the nasal passages. Respiratory infections or allergies cause the body to send white blood cells to the nose, throat, and sinuses, causing the nasal mucosa to swell and produce mucus. Decongestants constrict blood vessels in the sinuses and nose, thereby reducing swelling and helping fluid drain.
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Some scientists say phenylephrine in pill form is absorbed in the intestines and metabolized so well that only a small amount reaches the bloodstream, while it is needed to reach the nose, according to a citizen petition asking the FDA to remove the drug from store shelves. Citizen petitions are a way for industry, consumer groups, or individuals to ask the FDA to change regulations or take other administrative action.
In discussing Tuesday’s vote, the committee agreed that safety was not the reason they wanted the FDA to take action against the products. Instead, they recommended that the FDA take action because the pills are essentially a waste of money, while over-the-counter medications could help people with colds or allergies.
“It’s surprising that so many dollars are being spent on something that actually has no efficacy,” said committee member Dr. William Figg, a clinical pharmacologist and researcher at the National Cancer Institute.
Every year, many Americans seek relief from over-the-counter cold and allergy medications. According to the American Lung Association, approximately 60 million people in the United States suffer from allergies, and adults have two to four colds per year, for a total of 1 billion colds per year.
Research shows that colds and allergies can have a significant impact on quality of life. In addition to a runny nose and cough, allergies and colds can aggravate asthma and cause sleep problems.
Changing the name of phenylephrine can 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, opposed the change.
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The association said Tuesday it was disappointed with the committee’s decision and encouraged the FDA to “consider the full range of evidence supporting this long-standing over-the-counter ingredient” and “related to any potential changes in the regulatory status of oral PE” before making any regulatory changes. significant unintended negative consequences. “
He told the FDA committee that his surveys show people prefer decongestants in tablet form to nasal sprays. The association said if these drugs were no longer available, there could be a real burden on consumers.
An FDA committee said Tuesday that if the agency decides to reclassify phenylephrine and remove it from the market, the agency will need to educate the public about why some popular allergy and cold drugs are no longer available.
If phenylephrine is no longer available, other over-the-counter options include nasal spray antihistamines, nasal corticosteroids, nasal saline products, and pseudoephedrine tablets.
Pseudoephedrine products are considered over-the-counter drugs, but they are kept behind the counter because large amounts of pseudoephedrine can be used to make the illegal drug methamphetamine.
——CNN’s Meg Tirrell contributed to this report.
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