Rome, 29 October – New important information note from AIFA, which has updated the contraindications of use for thiocolchicoside-based medicines for systemic use (i.e. oral and intramuscular forms) and extended the contraceptive measures for female and male patients.
Medicines based on thiocolchicoside, he explains lhe information note released yesterday by the regulatory agencynationalare contraindicated, and therefore must not be used:
♦ in male patients who do not wish to use effective contraceptive measures during treatment with thiocolchicoside for systemic use and for three months after discontinuation of thiocolchicoside, and
♦ in female patients of childbearing age, who do not use effective contraceptive methods during treatment with thiocolchicoside for systemic use and for one month after discontinuation of thiocolchicoside.
Thiocolchicoside for systemic use, commonly used, alone or in association with anti-inflammatories or painkillers, in the treatment of muscle contractures, given the marked muscle relaxant action, remains contraindicated even in women of childbearing age who do not use effective contraceptive methods during treatment and in women during pregnancy and breastfeeding.
The active ingredient has long been a special observation of regulatory agencies: already in March 2019 Ema and Aifa had disclosed to the medical community the preclinical results which showed a risk of genotoxicity associated with the systemic use of thiocolchicoside, detailing the contraindications to use; prescription prohibited for pregnant or breastfeeding women, and women of childbearing potential, unless they adopt effective contraceptive methods. Already back then, again in an important information note, Aifa had also communicated to healthcare workers that “the use of systemic thiocolchicoside is limited to the short-term adjuvant treatment of painful muscle contractures in acute pathologies of the spine in adults and adolescents aged 16 years and older” and that “the recommended maximum daily doses and duration of treatment must be respected, i.e. 16 mg per day for up to 7 days for oral use and 8 mg per day for a maximum of 5 days intramuscularly”.
The updated information, the agency informs, is being implemented in the literature of the respective medicines.
