COLTRAMYL and thiocolchicoside generics, muscle relaxant
RHEUMATOLOGY - Update
Opinions on drugs - Posted on Nov 03 2016
Reason for request
Re-assessment of the actual benefit and the improvement in actual benefit
Insufficient actual benefit in the management of painful muscle contractures associated with acute low back pain
- COLTRAMYL has Marketing Authorisation in the adjuvant treatment for painful contractures in acute lumbar pain.
- Its efficacy is at best modest.
- A risk of aneuploidy, known to be a potential risk factor for cancer and for teratogenicity, embryotoxicity, spontaneous abortion and impaired male fertility, has been associated with its use.
- Considering that alternatives exist for which this risk has not been demonstrated, the clinical interest of thiocolchicoside is henceforth insufficient to justify its reimbursement.
Évaluation des médicaments