In the journal Prescrire, the famous antispasmodic drug Spasfon is once again suspected of not being very effective against most of the disorders it is supposed to treat, or even of not being more active than a placebo.
- The Prescrire magazine believes that Spasfon provides nothing more than a placebo, except for certain benign intestinal disorders where its effectiveness remains modest. Despite this, it is still reimbursed, representing a cost of 14 million euros in 2023.
- Critics point to insufficient scientific evaluation and rare but serious risks of side effects.
- The drug, prescribed mainly to women, also raises ethical questions and possible “gender bias”, according to the researchers.
Prescribed to relieve digestive, urinary, biliary or gynecological spasms, Spasfon is omnipresent in French pharmacies. 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 (Belgium), this phloroglucinol-based drug was once again highlighted, this Tuesday, November 26, by the medical journal Prescribe, relayed by AFP.
Spasfon, no more effective than a placebo?
If the drug, marketed by the Teva laboratory, is not among the 88 marketed treatments to be prohibited, it is because “its effectiveness is modest at best in recurrent benign intestinal disorders”but without certainty at this stage. It is only this doubt that saves him, to the extent that the 2025 assessment of Prescribe lists drugs that are more dangerous than useful in all situations in which they are authorized.
Gold, “in other clinical situations, whether urinary, gynecological, biliary or digestive, there is nothing to expect from phloroglucinol beyond the effectiveness of a placebo”according to the medical journal. The heart of the problem lies in the scientific evaluation of Spasfon: the authors criticize a “indiscriminate assessment” clinical studies, with limited or absent data for several of its disorders.
Despite these uncertainties, the drug continues to be reimbursed, up to 15% in certain cases, notably pain related to periods. In 2023, nearly 26.5 million boxes have been reimbursed by Health Insurance, at a cost of around 14 million euros.
Potentially serious side effects of Spasfon
The review, citing Vidal’s medical reference, also warns of potentially serious side effects of Spasfon, although rare: allergic reactions, angioedema, even anaphylactic shock. She says you should especially avoid taking Spasfon when you are pregnant, or planning to become pregnant.
The Teva laboratory, for its part, ensures that “knowledge about the effectiveness of these drugs on spasms of various origins is based on use in clinical research for several decades.”
For researcher Juliette Ferry-Danini, Spasfon poses a medical ethics problem. She describes its use as “waste of money” and underlines a “gender bias”because this medication is mainly prescribed to women, particularly for menstrual pain, without tangible proof of effectiveness. “It’s still crazy that we continue to give what could perhaps be akin to a placebo to patients.”
