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, phloroglucinol was not singled out today on Tuesday in the medical journal Prescrire.
Better known under the name Spasfon, this medication belongs to the class of antispasmodics. It is used in the treatment of painful spasms (contractions) of digestive (spasmodic colitis), biliary (hepatic colic), urological (renal colic) and gynecological (painful periods) origins according to Vidal. It exists in the form of coated tablets to swallow or orodispersible but also in suppositories or injectables.
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 nevertheless considered it. Spasfon, marketed by the Teva laboratory, escapes because “its effectiveness is modest at best in recurrent benign intestinal disorders“, but without certainty at this stage.
After reviewing clinical trial reports and systematic reviews that have evaluated phloroglucinol in the indications for which it is authorized, Prescrire points out:a poor assessment“, and even no evaluation in period-related pain even though it is reimbursed at 15% in this indication.
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, whereas Vidal indicates that “the scientific data currently available have not revealed any particular problem when using this medication during pregnancy at the recommended dose.“.
A drug little used in other European countries
Questioned by AFP, the Teva laboratory ensures that “knowledge of the effectiveness of these drugs on spasms of various origins is based on use in clinical research for several decades“. It underlines the wide use of these treatments. It remains that for Ms. Ferry-Danini, philosopher specializing in health, it remains “a fanco-French affair” since the main Western countries, apart from Italy, have not put Spasfon on their market.
The philosopher, who delved 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 do not pay enough attention to its ineffectiveness.
More “It’s still crazy that we continue to give what could perhaps be akin to a placebo to patients.“, reacted the researcher to AFP. 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.
To this financial problem is added a “gender bias“since Spasfon is first given to women, notes Ms. Ferry-Danini, who sent around ten questions to the French health authorities in the spring, which have remained unanswered to this day.”It’s not the Mediator (Editor’s note: the health and legal scandal surrounding an antidiabetic used as an appetite suppressant) but it’s still worth stopping at“, concludes Ms. Ferry-Danini.
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