Because of safety concerns related to aneuploidy, an abnormal number or arrangement of chromosomes, the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended that oral or injectable drugs containing the muscle relaxant thiocolchicoside be restricted across the European Union (EU).
Recommendations include restricting the maximum dose and number of days of treatment for thiocolchicoside-containing drugs, a press release from the EMA said.
Aneuploidy is an established risk factor for impaired male fertility and for teratogenicity, embryotoxicity, or spontaneous abortion.
Thiocolchicoside has been authorized in several EU Member States for use by mouth or injection in the treatment of painful muscular disorders, which could include low back and sciatic pain, cervicobrachial neuralgia, refractory torticollis, or post-traumatic and postoperative pain syndromes. Related medicines are now recommended for short-term use as an add-on treatment in adults and adolescents 16 years of age or older.
MEDSCAPE 2013
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