Health. Spasfon, Dolirhume, Humex… Why these drugs are not banned

Health.  Spasfon, Dolirhume, Humex… Why these drugs are not banned

Cold medications exposing you to cardiovascular risks, or treatment to soothe painful periods having no more effectiveness than a placebo… Recently the National Medicines Safety Agency (ANSM) warned of the risks associated with vasoconstrictors, these medicines used to relieve cold symptoms. The cause is an increased risk of cardiovascular events, pushing the authority to advise against the use of these products.

A few days ago, Juliette Ferry-Danini’s work “Pink pills, ignorance in medicine” clearly called into question the effectiveness of Spasfon, particularly in the treatment of pain linked to painful periods.

An opinion not so new since, in 2014, the High Authority of Health (HAS) explained that the actual benefit of Spasfon in the management of gynecological pain was low. Opinion that the health authority has since reiterated. So why are such drugs still on sale?

Is Europe’s fault?

For Professor Milou-Daniel Drici, the main reason is historical. “Until recently, it was the French medicines agency which decided on national marketing authorization. But since then, this competence has been at European level under the aegis of the European Medicines Agency. Thus, many drugs have been on the French market for more than 60 years (the authorization of Spasfon dates from 1976, editor’s note). And many have rendered medical service considered low or insufficient to justify reimbursement. »

We are talking here about “11,000 specialties which must be re-evaluated at regular intervals. Which takes time, but it is on this occasion that some are no longer renewed. »

Furthermore, for a drug to be withdrawn from the market, “it must meet certain regulatory conditions. Namely that adverse events have occurred since the last evaluation.” The ANSM therefore presented the “vasoconstrictors” file to Europe in February 2023 in order to reassess their benefit/risk balance. Which might be long. The authorities are therefore counting on patients not to use these products.

As for Spasfon, despite “modest effectiveness, its safety is acceptable”. In short, Spasfon, not very effective but not dangerous. “Which justifies keeping it on the market,” concludes Professor Milou-Daniel Drici.

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