Major drugstore voluntarily removes cold medicine containing phenylephrine from shelves, which was argued to be ineffective


by

jtrummer

Phenylephrine , one of the ingredients in cold medicine, was said to have a nasal congestion effect. However, many clinical trials and studies have shown that oral administration of phenylephrine is not effective, and in 2023, an advisory committee of the U.S. Food and Drug Administration (FDA) concluded that oral administration of phenylephrine is not effective. I concluded. In response to this, CVS, a major American drug store, is reportedly removing oral cold medicines containing phenylephrine from its shelves.

CVS to pull some cold, cough products with phenylephrine off shelves | Reuters
https://www.reuters.com/business/healthcare-pharmaceuticals/cvs-health-remove-cold-medicine-with-phenylephrine-shelves-wsj-2023-10-19/



CVS ditches common cold meds after FDA advisers say they're useless | Ars Technica
https://arstechnica.com/health/2023/10/cvs-ditches-useless-cold-meds-but-not-bogus-homeopathic-products/



Phenylephrine is a type of adrenergic agonist and is used as a vasoconstrictor. Some drugs are inactivated by enzymes in the body when administered orally, but phenylephrine was thought to work without being affected by this. However, in September 2023, an FDA advisory committee unanimously concluded that ``oral administration of phenylephrine has no therapeutic effect on nasal congestion.''

An advisory committee of the U.S. Food and Drug Administration has determined that anti-rhinitis ingredients used in commercially available cold medicines and anti-allergy medicines are ``ineffective when ingested orally'' - GIGAZINE



At the time of writing, the FDA has not yet removed phenylephrine from its list of active ingredients, but the FDA's advisory committee's denial of the therapeutic efficacy of orally administered phenylephrine may lead to future approval of cold medicines containing phenylephrine. It is highly likely that it will be cancelled.

In response to these developments, CVS, a major American drug store, has announced that it will voluntarily remove some cold and flu medicines from its shelves in October 2023.


by Mike Mozart

CVS is 'retiring a small number of oral decongestants with phenylephrine as the only active ingredient from CVS stores, but will continue to offer other decongestants and cold medicines to meet consumer needs.' says. A CVS spokesperson commented to the IT news site Ars Technica, ``The decision by the FDA's advisory committee prompted the change. We will follow the FDA's instructions.''

Walgreens, a pharmacy chain that competes with CVS, said in a statement: 'We are following FDA regulations and are monitoring the situation.'

The research that led to phenylephrine's approval by the FDA in 1976 has been found to be seriously flawed, and clinical trial results published in 2015 also showed it would be ineffective. Ta. Further, subsequent pharmacological studies have shown that phenylephrine is metabolized in the intestine, leaving less than 1% of the active drug bioavailable. Therefore, Ars Technica says, ``The removal of phenylephrine-containing products from pharmacy shelves is a long-awaited victory for both researchers and consumers.''


by Mike Mozart

in Note,   Science, Posted by log1i_yk