Mebeverine (Colofac) Availability in the United States
No, mebeverine is NOT commercially available in the United States for the treatment of irritable bowel syndrome or gastrointestinal conditions.
Clear Statement from Guidelines
The 2022 AGA Clinical Practice Guidelines explicitly state that "Of the antispasmodics studied, only hyoscine, dicyclomine, and peppermint oil are available in the United States" 1. Mebeverine is notably absent from this list of available antispasmodic agents.
Important Caveat About FDA Database Listing
The FDA database entries 2 listing "Colofac" refer to a completely different product - a topical cold sore/fever blister treatment for external use only. This is NOT the mebeverine antispasmodic medication used for IBS. This represents a common source of confusion when searching drug databases, as the same brand name may be used for entirely different products in different countries.
Alternative Options Available in the US
For patients seeking antispasmodic therapy for IBS in the United States, the following options ARE available 1:
- Hyoscine (scopolamine)
- Dicyclomine
- Peppermint oil
These agents have demonstrated efficacy for global IBS symptom relief (RR 0.67,95% CI 0.55-0.80) and abdominal pain improvement (RR 0.74,95% CI 0.59-0.93), though the certainty of evidence is low to very low 1.
Why This Matters Clinically
While research demonstrates mebeverine's efficacy for IBS symptoms 3, 4, and it remains widely used internationally, US practitioners cannot prescribe it and should instead utilize the FDA-approved antispasmodic alternatives listed above when antispasmodic therapy is indicated.