A phenylephrine a popular ingredient in many over-the-counter medicines for allergies and colds, is ineffective in tablet form, an independent advisory committee to the U.S. Food and Drug Administration (FDA) agreed Tuesday.
Phenylephrine is the main ingredient used in products such as Benadryl Allergy Plus Congestion, Sudafed PE, and Vicks Sinex. The ingredient is considered safe for use; that was not up for debate. But many doctors have questioned phenylephrine’s effectiveness for years.
These products generated nearly $1.8 billion in sales last year alone, according to FDA data that was presented to the Nonprescription Drug Advisory Committee on Monday during its two-day meeting. of the committee.
On Tuesday (12), the committee voted “no” on the specific question: “Does the current scientific data presented support that monographic dosage of phenylephrine administered orally is effective as a nasal decongestant?”
The vote was unanimous among its 16 members, and the commission agreed that the matter does not need to be studied further.
“We really shouldn’t have products on the market that aren’t effective,” said committee member Dr. Diane Ginsburg of the University of Texas at Austin College of Pharmacy.
The FDA told the committee it would take its advice into consideration, although it did not provide a timeline. If the agency decides to reclassify phenylephrine from Generally Recognized as Safe and Effective (GRASE), interested parties will have the opportunity to comment on the proposed change and provide any additional data.
During this process, companies could still market products with phenylephrine. But if the FDA agrees with the committee, companies could be forced 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 even more common after 2005, when legislation restricted access to medications that use a similar decongestant ingredient called pseudoephedrine.
In 2007, the FDA committee looked at the science available at the time and came to a different conclusion, agreeing that phenylephrine “may be effective” but also calling for more research. Since then, studies, including three large clinical trials, have shown that the orally administered ingredient is not effective as a decongestant at its typical dosage.
The committee also reviewed other research used to support its over-the-counter use. The FDA found that the results of these studies were inconsistent and many did not meet modern scientific standards.
The committee did not address the issue of nasal sprays using phenylephrine, which studies appear to show are effective, at least temporarily.
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 citizens’ petition to remove the drug’s over-the-counter status.
Phenylephrine works by temporarily reducing the swelling of blood vessels in the nasal passages. A respiratory infection or allergy causes the body to send white blood cells to the nose, throat, and sinuses, causing the nasal membranes to swell and create mucus. Decongestants constrict blood vessels in the sinuses and nose, reducing swelling and helping fluids drain.
In pill form, some scientists say, phenylephrine is absorbed from the intestine and metabolized so well that only a small amount reaches the bloodstream, where it is needed to reach the nose, according to the citizens’ petition asking the FDA to withdraw it. the medicine from store shelves.
This type of petition is a way for industry, consumer groups, or individuals to ask the FDA to change regulations or take other administrative action.
When discussing Tuesday’s vote, the committee agreed that safety was not why they wanted the FDA to take action on these products. Instead, they were advising the FDA to take action because the pills were essentially a waste of money and other over-the-counter medications can help people who have colds or allergies.
“It’s incredible the amount of dollars spent on something that really has no efficacy,” said committee member Dr. William Fig, a clinical pharmacologist and investigator at the National Cancer Institute.
Every year, many Americans seek relief from over-the-counter cold and allergy remedies. About 60 million people in the United States have allergies, and adults get two to four colds a year, according to the American Lung Association, for a total of 1 billion colds a year.
Colds and allergies can have a significant effect on quality of life, studies show. In addition to a runny nose and cough, allergies and colds can aggravate asthma and cause trouble sleeping.
A change in the name of phenylephrine could cost manufacturers dearly. The Consumer Healthcare Products Association, which represents manufacturers of over-the-counter drugs and dietary supplements as well as consumer medical devices, opposes a change.
The association said Tuesday it was disappointed with the committee’s decision and encouraged the FDA, before making any regulatory changes, to “be mindful of the totality of evidence supporting this long-standing over-the-counter ingredient, as well as the consequences significantly negative unwanted effects associated with any potential change in oral regulatory status.”
The agency told the FDA committee that its research shows that people prefer their decongestants in pill form to nasal sprays. If these medicines were no longer available, it could be a real burden on consumers, the association said.
On Tuesday, the FDA committee said that if the FDA decides to reclassify phenylephrine and it goes off the market, the agency will need to educate the public about why some of the popular allergy and cold medications were no longer 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, as well as pseudoephedrine tablets.
Pseudoephedrine products are considered over-the-counter, but are kept over the counter because, in large quantities, pseudoephedrine can be used to produce the illegal drug methamphetamine.
*With information from Meg Tirrell, from CNN.
Source: CNN Brasil
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