An independent advisory council to the US Food and Drug Administration decided on Tuesday that phenylephrine, a common ingredient in many over-the-counter allergy and cold medications, is ineffective in tablet form.
The primary component of medications like Vicks Sinex, Sudafed PE, and Benadryl Allergy Plus Congestion is phenylephrine.
There was no disagreement that the component is regarded as safe for usage. But for years, many medical professionals have questioned the efficacy of phenylephrine.
Data from the FDA was provided to the Nonprescription Drug Advisory Committee on Monday at the committee’s two-day meeting, showing that these items produced close to $1.8 billion in sales just last year.
Although it did not provide a timeframe, the FDA assured the committee that it would take its recommendations into account. Stakeholders would have the chance to comment on the proposed modification and to offer any further data if the FDA chooses to reclassify phenylephrine from Generally Recognized as Safe and Effective (GRASE).
Businesses would still be able to promote items containing phenylephrine throughout that time. But, if the FDA concurs with the committee, businesses may be ordered to either reformulate or remove phenylephrine-containing items from shop shelves.
Several studies that supported its over-the-counter use were also examined by the committee. The FDA discovered that several of the study’s findings did not adhere to current scientific standards and were inconsistent.
Impact on Allergy and Cold Remedies
The subject of phenylephrine-based nasal spray products, which studies seem to indicate are useful, at least temporarily, was not discussed by the committee.
The American Academy of Allergy, Asthma and Immunology states that phenylephrine is the most frequently found ingredient in over-the-counter oral nose and sinus products.
The organization sponsored a public petition to end the drug’s classification as an over-the-counter medication last year.
The way phenylephrine works is by momentarily lessening the nasal blood vessel enlargement.
Inflammation of the nasal membranes and the production of mucus are caused by the body sending white blood cells to the nose, throat, and sinuses in response to an infection or allergy. Decongestants reduce edema and aid in fluid drainage by constricting the blood arteries in the sinuses and nose.
Manufacturers can incur expenses if the designation of phenylephrine is changed. The Consumer Healthcare Products Association, which represents manufacturers of consumer medical devices, over-the-counter medications, and nutritional supplements, is opposed to a change.
The FDA committee stated on Tuesday that in the event that the agency decides to reclassify phenylephrine and the drug is taken off the market, the FDA will be required to inform the public of the reasons why some of the most well-liked allergy and cold medications were no longer available.
There are a number of different over-the-counter (OTC) options if phenylephrine is no longer accessible, including antihistamine nasal sprays, nasal corticosteroids, and nasal saline solutions, as well as tablets with pseudoephedrine.