Martina Freiarticle published on Infosperber April 30, 2025, translated and adapted by good for the head
It is a market that weighs several billion: around 70 products contain phenylephrine in the United States. These are mainly cough drugs, colds or allergies. In 2022 alone, it is estimated that 242 million boxes, for a value of around 1.8 billion dollars, were sold in American stores. Pharmacies have sold more than $ 3 billion in products containing phenylephrine. The American authority responsible for medicines, the FDA, now wants to end this practice.
In Switzerland, Neocitran influenza and neotylenol drugs, among others, contain phenylephrine in addition to other active ingredients. This substance is supposed to have a decongestant effect, for example in case of colds.
But in November 2023, after examining numerous studies, an FDA advisory committee concluded unanimously that phenylephrine had no effect when it was taken orally. The FDA therefore proposed last November to withdraw phenylephrine from over -the -counter products intended to be ingested (and not for local use, for example in nasal spray). She opened a public consultation.
A new era?
Since then, the FDA has received hundreds of comments. Some consumers insisted that only phenylephrine relieved them. Others have argued that it had to be removed from the market to prevent buyers from believing that it was effective. Still others have considered that oral phenylephrine could continue to be sold freely, because it was ultimately not dangerous in the recommended doses.
Prohibiting a substance already marketed and authorized for an unlimited period due to its ineffectiveness would constitute a reversal in relation to the usual practice of the pharmaceutical authorities. Indeed, until then, the authorities withdrew from the Maché drugs to the active ingredients judged at risk or when commercial reasons opposed it, say two scientists in the American medical newspaper Jama.
Only a few treatments have proven effectiveness
If the FDA actually removed phenylephrine for oral use of the market due to its ineffectiveness, it would open a significant breach. Because what would be the next step?
-The choice is vast. It ranges from extremely expensive anticancer drugs to various “soft” remedies that are no more effective than a placebo. According to the two scientists of Jamamany products would probably be failed if their effectiveness was again tested in practice. Indeed, only a few treatments have “solid evidence regarding their quality and efficiency”.
New drugs often have no notable advantage compared to existing treatments, also confirmed Jonathan Darrow, American lawyer and expert on the marketing of medicines, in the Journal of Managed Care et Specialty Pharmacy In 2021.
He cites in particular a study by the German Institute for quality and efficiency in the field of health care. According to this study, out of 216 newly authorized drugs, only 32 offered considerable additional benefit and 22 a significant benefit. There were therefore 125 newly authorized drugs which had an advantage only from the point of view of manufacturers, but not that of the people who examined them critically. The latter found no evidence of additional profit for patients.
The situation was particularly serious in psychiatry and neurology: the evaluators certified added value only for 6 % of newly authorized drugs. The alleged “pierced” in cancerology were hardly better.
Ineffective products manufacturers will have to fear for their activity
Another systematic verification of newly authorized anticancer drugs in the EU between 2009 and 2013 for different types of cancer showed that in more than half of the cases, nothing proved that these drugs allowed patients to live significantly longer or better. These drugs were nevertheless put on the European market and remained there, although, three years later, in 33 cases out of 68, manufacturers have still not provided proof of their effectiveness for patients.
Martin Makary, the new FDA director, recently came into office. Makary has been one of the most virulent detractors of unnecessary treatments for years. If he actually implements what he has advocated so far, many manufacturers of ineffective products, over the counter or on a prescription, will have to fear for their activity.
No withdrawal of the market in Switzerland for the moment
In our country, the withdrawal of the market ordered by the authorities from an authorized substance for an unlimited but ineffective period would be a first. In any case, the experts interviewed know no similar example in the past. The Swiss Swissmedic drug control authority said that the result of the FDA review procedure would be taken into account in its evaluation.
