FDA says nasal decongestant in best-selling flu medicines is not effective

2023-09-15 14:39:26

The fenilefrina oral It is used in over-the-counter cold medicines that are indicated for temporary relief of congestion. In fact it is located in the formula of many anti-flu. But now a review of the scientific evidence on this active ingredient carried out by the US Food and Drug Administration (FDA) has concluded that is no more effective than a placebo in its oral format.

The FDA held a meeting of the Nonprescription Drug Advisory Committee on September 11 and 12 to discuss new data on the effectiveness of phenylephrine and concluded that the scientific evidence currently available does not support that the recommended dose of phenylephrine administered orally is effective as a nasal decongestant. However, neither the FDA nor the committee expressed concerns about safety issues with the use of oral phenylephrine at the recommended dose.

The vote was unanimous among its 16 members and the committee agreed that the issue does not need to be studied further. “We really shouldn’t have products on the market that are not effective,” says committee member Dr. Diane Ginsburg of the University of Texas at Austin School of Pharmacy, CNN reports.

Leslie Hendeles, PhD in Pharmacy from the University of Florida, points out that There are other over-the-counter products. available to relieve congestion, including decongestants in aerosol nasal de fenilefrina y oxymetazolineas well as pseudoefedrina oral. “It is only the oral route of phenylephrine that is not effective, because 99% of the original drug is inactivated in the intestine and during the first passage through the liver,” explains Hendeles in a statement from the American Pharmacists Association.

Hendeles helped lead a University of Florida citizen petition filed in 2015 requesting the removal of oral phenylephrine from the final monograph for over-the-counter nasal decongestant products.

The FDA advisory committee focused on whether “the pharmacological effect of the drug, when used in accordance with proper instructions for use and warnings against unsafe use, will provide clinically significant relief of the type claimed.” Using that standard, “we have now initially concluded that orally administered phenylephrine (PE) is not effective as a nasal decongestant at the monographed dose (10 mg PE hydrochloride every 4 hours), as well as at doses up to 40 mg (dosed every 4 hours). hours),” FDA documents noted before the meeting.

FDA scientists presented the results of five studies conducted over the last two decades on the effectiveness of oral phenylephrine. All studies found that is no more effective than a placebo. FDA members also heard testimony from industry, doctors, pharmacists and other experts during the two-day meeting.

Advisory committees provide independent advice and recommendations to the FDA, which makes the final decision. The agency will consider input from this advisory committee and the evidence before taking any action on the status of oral phenylephrine.

Many over-the-counter medications, including phenylephrine, are sold because they have an ingredient that the FDA generally recognizes as safe and effective (GRASE) when used as recommended on the product label, which is documented in an ‘over-the-counter monograph. ‘.

If the FDA determines that oral phenylephrine is not effective, the agency would first issue a proposed order to remove phenylephrine from this monograph. The public would then have the opportunity to comment on the proposed order. If, after considering the comments, the FDA continued to conclude that phenylephrine is not effective, the agency would issue a final order removing this ingredient from the monograph and phenylephrine would no longer be considered safe and effective. The agency would then work closely with manufacturers to reformulate the drugs as needed to help ensure the availability of safe and effective products to treat cold or allergy symptoms.

There are a range of products available for the temporary relief of symptoms of congestion due to allergies or the common cold. Some of them only contain phenylephrine, while others also contain another active ingredient, such as paracetamol or ibuprofen, which treats symptoms other than congestion, such as headaches or muscle aches.

Phenylephrine is also an ingredient in nasal sprays to treat congestion. But the advisory committee’s discussion and recommendations only related to orally administered phenylephrine, so the Nasal sprays containing phenylephrine will not be affected for any possible action taken on orally administered products such as tablets or capsules.