Is Spasfon ineffective? This very popular medication in France, since it is widely prescribed or used for self-medication, aims to combat spasmodic pain in the intestine, bile ducts, bladder and uterus.
But its effectiveness is questioned. A book published in 2023, “Pink pills: Ignorance in medicine” by Juliette Ferry-Danini, teacher-researcher at the University of Namur, in Belgium, had already scratched the usefulness of this drug. Today, it is the independent medical journal Prescrire, a reference in terms of drug evaluation, which points out its potential ineffectiveness.
At the end of 2024, the evaluation of phloroglucinol (Spasfon) remains poor. Its symptomatic effectiveness on recurrent benign intestinal disorders is uncertain. In other clinical situations, there is nothing to expect from phloroglucinol beyond the effectiveness of a placebo. It is prudent to advise against taking it as self-medication, which is commonplace in France.
Not dangerous, but useless?
According to the review’s report, Spasfon is not one of the 88 marketed drugs to be ruled out as dangerous, but its effectiveness “is modest at best” in recurrent benign intestinal disorders.
Spasfon is composed of phloroglucinol: a compound which would not be effective in urinary, biliary, digestive or gynecological clinical situations.
In an opinion from the Transparency Commission dating from 2017, summarized by the public drug database, it was already written as follows:
“The medical benefit provided by SPASFON specialties remains low in:
• symptomatic treatment of pain linked to functional disorders of the digestive tract,
• the treatment of acute spasmodic and painful manifestations of the urinary tract: renal colic,
• symptomatic treatment of painful spasmodic manifestations in gynecology,
• adjuvant treatment of contractions during pregnancy in combination with rest.”
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14 million euros from Spasfon repaid in 2023
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.
In 2023, in France, Health Insurance reimbursed around 26.5 million boxes of phloroglucinol tablets, for a total amount of around 14 million euros, according to figures from Prescrire. Without forgetting that, like any medication, it can also have side effects: allergic reactions (skin rash, rarely hives, itching) and in exceptional cases, angioedema and anaphylactic shock, according to Vidal.
A gender bias
This massive use of Spasfon is also aimed at women and pain linked to menstrual cycles, even if the effectiveness is very uncertain. As reported by an article in the Voix du Nord, the philosopher specializing in health Juliette Ferry-Danini points out this problem and claims to have sent questions on the subject to the health authorities, which remained unanswered: “It is not the Mediator (the health and legal scandal surrounding an antidiabetic drug which caused the death of thousands of people) but it deserves that we stop at it all the same,” she declares.
Especially since this drug remains widely and almost exclusively used in France, since the main Western countries, apart from Italy, have not put Spasfon on their market.
The Teva laboratory, which produces Spasfon, assured AFP that “knowledge on the effectiveness of these drugs on spasms of various origins is based on use in clinical research for several decades”, and underlines the wide use of these treatments.
