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Wockhardt UK discontinues Diazepam RecTubes 2.5mg 'due to manufacturing issues'

Pharmaceutical company Wockhardt UK has decided to discontinue Diazepam RecTubes 2.5mg Rectal “due to manufacturing issues”, the Department of Health and Social Care (DH) has announced. 

Supplies of Diazepam RecTubes 2.5mg – which is “licensed in acute severe anxiety and agitation, epileptic and febrile convulsions and tetanus” – are expected to be exhausted by March 2022, the DH said in a supply disruption alert issued yesterday (October 11). 

The medication is also used as a sedative in minor surgical and dental procedures and in circumstances where rapid effect is required and where intravenous injection is not appropriate.

Diazepam RecTubes 2.5mg are used off-label in children under one year old, “mainly...in the management of status epilepticus and convulsions in neonates”.

 

Advice for healthcare professionals

 

The DH has advised healthcare professionals not to initiate new patients on Diazepam RecTubes 2.5mg; and update the patient’s epilepsy passport or child’s emergency care plans immediately if any changes to treatment are required.

They should also review all patients prescribed Diazepam RecTubes 2.5mg and relevant local guidelines and protocols that recommend the use of Diazepam RecTubes 2.5mg, to consider alternative preparations where appropriate.

“Diazepam 5mg/ 2.5mL rectal solution remains available and can support an uplift in demand,” the DH said.

Alternative parenteral and non-parenteral preparations also remain available, it added.

Read the full alert here

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