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Migraine: sumatriptan remains available only on prescription in France

Oral sumatriptan for the treatment of migraine in adults remains available only on prescription.

In France, sumatriptan is marketed as a treatment for migraine in adults. Sumatriptan-based products are available solely on prescription.

The first-line treatment for migraine should be non-drug based (bed rest, relaxation, acupuncture) and nonspecific analgesics. It is only after two or three migraine attacks that are resistant to nonspecific analgesics that a drug treatment should be envisaged, preferably sumatriptan. It is rapidly effective in around 75% of patients.

The adverse effects profile of sumatriptan and of triptans in general is extensive (cardiovascular disorders, convulsions, self-sustaining headaches, etc.). Sumatriptan should not be prescribed to patients presenting a hypersensitivity to sulphonamides, those with cardiovascular disorders or to pregnant or breastfeeding women. Furthermore triptans expose patients to numerous drug interactions.

The French drug regulatory agency refused GlaxoSmithKline’s application for sumatriptan to be available over the counter. There were several reasons for this refusal: the need for a medical diagnosis to identify a migraine requiring triptan treatment; the cardiovascular risks, self-sustaining headaches in the case of frequent use, and drug interactions. In 2010, the agency concluded that: “this product is considered to have a negative harm-benefit balance when used for self-medication”.

The French agency is moving in the right direction by upholding the need for a prescription for these drugs, which are not risk-free.

©Prescrire 1 January 2012

"Sumatriptan without a prescription. Application rejected in France" Prescrire Int 2012; 21 (123): 9. (pdf, subscribers only)
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