LONDON (Reuters) - European drugs regulators on Friday recommended restricting the use of tolperisone and trimetazidine-containing medicines due to worries about the risk-benefit balance.
The European Medicines Agency (EMA) said doctors should no longer prescribe trimetazidine, a generic drug, for the treatment of patients with tinnitus, vertigo or disturbances in vision, and in patients with angina pectoris they should restrict its use to only a second-line or add-on therapy.
Patients taking trimetazidine should discuss alternatives with their doctor, it said.
EMA said its call for restriction on use of tolperisone, a generic muscle relaxant drug used to treat spasticity and muscle spasms, was due to concerns over hypersensitivity reactions.
"Taking into account that the risk of hypersensitivity reactions... the committee concluded that the benefits of tolperisone outweighed its risks only in the treatment of adults with post-stroke spasticity and only when used as an oral formulation," it said in a statement.
(Reporting by Kate Kelland)