A French exception: Phloroglucinol, better known under the trademark Spasfon, continues to be used widely and almost exclusively in France, despite widespread doubts about its effectiveness.
Already in the spotlight in 2023 with the publication of the book Pink pills: ignorance in medicine By Juliette Ferry-Danini, professor and researcher at the University of Namur, in Belgium, Spasfon was highlighted this time on Tuesday in the medical journal Prescrire.
Spasfon belongs to a class of medicines called antispasmodics that work against spasms (contractions). This medication is indicated for the treatment of spasmodic pain in the intestine, bile ducts, bladder and uterus. It is best known in the form of a smooth, shiny tablet, recognizable by its pink color, but it also exists in rectal and injectable form.
Although phloroglucinol is not on the list of 88 drugs marketed in France that should be excluded, according to the 2024 report published by Prescrire, the independent review has “considered” it.
Spasfon, marketed by the Teva laboratory, escapes because “its effectiveness is, at best, modest in recurrent benign intestinal disorders”, but without certainty at this point.
Inconsistent recommendations
Only this doubt saves you insofar as Prescrire’s evaluation lists medications that are more dangerous than useful in all situations in which they are authorized.
However, “in other clinical situations, whether urinary, gynecological, biliary or digestive, one cannot expect from phloroglucinol beyond the effectiveness of a placebo,” concludes the review considered a reference in pharmaceutical matters.
Having reviewed clinical trial reports and systematic reviews that have evaluated phloroglucinol in the indications for which it is authorized, Prescrire notes “a poor evaluation,” and even no evaluation in period-related pain, although it is reimbursed at 15 % in this indication.
Requested several times by BFMTV.com, the Ministry of Health never wanted to comment on the hypothetical need to remove this very popular product in France from the list.
“A waste of money”
However, taking Spasfon, like most medications, is not innocent. It can cause allergic reactions (skin rash, rarely hives, itching) and in exceptional cases, angioedema and anaphylactic shock, lists the bible of medicines, Vidal.
According to Prescrire, you should especially avoid taking Spasfon if you are pregnant or planning to become pregnant.
Questioned by AFP, the Teva laboratory assures that “knowledge about the effectiveness of these drugs on spasms of various origins is based on their use in clinical research for several decades.” The wide use of these treatments stands out.
The truth is that for Juliette Ferry-Danini, a health philosopher, this remains “a Franco-French issue”, since the main Western countries, apart from Italy, have not put Spasfon on their market.
The philosopher, who investigates the history of the drug – conceived in the early 1960s by the Lafon laboratory as a choleretic before being marketed as an antispasmodic – maintains that the authorities hardly examine its ineffectiveness because its risks remain limited.
But “it is still crazy that we continue giving patients what would perhaps be a placebo,” exasperates the researcher to AFP, who sees this as “a large-scale medical ethics problem,” “a waste of money, without doubt”. “.
In fact, in 2023, in France, health insurance reimbursed around 26.5 million boxes of phloroglucinol tablets, for a total amount of around €14 million, according to Prescrire figures.
Adding to this economic problem is a “gender bias”, since Spasfon is administered to women for the first time, says Juliette Ferry-Danini, who in spring sent a dozen questions to the French health authorities, which to this day they still have no response.
“It is not the Mediator (Editor’s note: the health and legal scandal surrounding an antidiabetic drug used as an appetite suppressant) but it nevertheless deserves a closer look,” concludes Juliette Ferry-Danini.
Source: BFM TV
