HC Deb 05 August 1976 vol 916 c1028W
Mr. Pavitt

asked the Secretary of State for Social Services if he is satisfied that doctors prescribing Dantrolene are fully aware of the risks and the need for regular monitoring of the liver functions of patients on long-term use; and if he will issue advice to doctors that other drugs such as Diazepam or Baclofen should be prescribed until more experience of this drug has been acquired.

Dr. Owen

A product licence authorising the monitored release of Dantrolene sodium was granted on the advice of the Committee of Safety of Medicines in December 1974. It was a condition that the company arranged to ask every doctor using the product to furnish a follow-up report in order that the incidence of complications, particularly of liver disorders, could be assessed. It was also required that all promotional material for the product should be submitted to the licensing authority for approval. Following a report on the results of the follow-up exercise, the requirement for reports on new patients ended in June this year. Promotional material remains subject to pre-publication approval. It includes a warning of the risk of liver damage and advises doctors that regular liver function tests should be performed on all patients on long-term therapy. On the evidence currently available I am advised that additional action at this stage is not justified.