The European Medicines Agency (EMA) has launched a review of the effectiveness of combined methocarbamol and paracetamol for the treatment of painful muscle spasms.
The review is being carried out at the request of the German medicines agency (BfArM), which has been asked to evaluate a marketing application for a generic medicine based on Robaxisal compuesto, which is authorised in Spain for painful muscle spasms associated with various short-term muscle disorders. Robaxisal compuesto combines 380 mg of methocarbamol and 300 mg of paracetamol.
New scientific evidence deriving from a Cochrane Review has raised concerns with regard to the efficacy of paracetamol in low back pain.
The EMA has asked the drug manufacturers to provide a full benefit-risk assessment of methocarbamol/paracetamol-containing medicinal product(s) for oral use in the short-term, symptomatic management of painful muscle spasms associated with acute musculoskeletal disorders.
Additionally, it has requested scientific evidence related to the safety of methocarbamol/paracetamol-containing products. “The risk of interactions, especially an increase of the toxic metabolite of paracetamol N-Acetyl-p-benzoquinoneimine should be discussed taking into account that both substances are metabolised in the liver and conjugated to glucuronic and sulfuric acid,” the agency said.
The deadline for receipt of this information is 29 August 2019.