Already in the spotlight in 2023 with the publication of the book “Pink Pills: Ignorance in Medicine” by Juliette Ferry-Danini, teacher-researcher at the University of Namur, in Belgium, Spasfon is this time highlighted on Tuesday in the medical journal Prescribe.
Doliprane: could the State prevent the sale?
Could the sale of Doliprane manufacturer be avoided? Was it necessary? If France and the European Union have sovereignty tools, nothing says that it was wise to mobilize them on this issue
Spasfon belongs to a class of medicines called antispasmodics which work against spasms (contractions). This medication is indicated in the treatment of spasmodic pain of the intestine, bile ducts, bladder and uterus. It is best known in the form of a smooth and shiny tablet, recognizable by its pink color, but it also exists in rectal and injectable forms.
“Nothing to wait for”
If phloroglucinol does not enter the list of 88 drugs marketed in France which should be excluded, according to the 2024 report published by Prescrire, the independent review has nonetheless “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 stage.
It is only this doubt that saves him to the extent that Prescrire’s assessment lists drugs that are more dangerous than useful in all the situations in which they are authorized. However, “in other clinical situations, whether urinary, gynecological, biliary or digestive, there is nothing to expect from phloroglucinol beyond the effectiveness of a placebo”, concludes the review considered as a reference on pharmaceutical subjects.
After having gone through clinical trial reports and systematic reviews which have evaluated phloroglucinol in the indications for which it is authorized, Prescrire points to “an indigent evaluation”, and even no evaluation in pain linked to periods even though it is reimbursed at 15% in this indication.
Allergic reactions
However, taking Spasfon, like most medications, is not innocent. It can cause allergic reactions (skin rash, rarely urticaria, itching) and in exceptional cases, angioedema and anaphylactic shock, lists the bible of medications, Vidal.
According to Prescrire, you should particularly avoid taking Spasfon when you are pregnant, or planning to become pregnant. When questioned, the Teva laboratory assures that “knowledge on the effectiveness of these drugs on spasms of various origins is based on use in clinical research for several decades”. He highlights the wide use of these treatments.
The fact remains that for Juliette Ferry-Danini, a philosopher specializing in health, this remains “a Franco-French affair” since the main Western countries, apart from Italy, have not put Spasfon on their market.
14 million euros
The philosopher, who dug into the history of the drug – designed in the early 1960s by the Lafon laboratory as a choleretic before being marketed as an antispasmodic – argues that the authorities hardly look into its ineffectiveness because its risks remain limited .
But “it’s still crazy that we continue to give what would perhaps be akin to a placebo to patients,” exasperates the researcher who sees this as “a large-scale medical ethics problem,” “ a waste of money, most certainly.” In 2023, in France, Health Insurance has, in fact, reimbursed around 26.5 million boxes of phloroglucinol tablets, for a total amount of around 14 million euros, according to figures from Prescrire.
