Valproic acid (as semisodium valproate)
Indication
Manic episodes associated with bipolar disorder.
Amber level 0
Brand:
Depakote
Nice TA:
Commissioning responsibility:
CCG
PbR excluded:
No
BNF chapter:
Central nervous system
Background
LSCMMG is adopting the local decision made prior to April 2013
In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:
- Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
- At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued
The colour classification was determined as part of the collaborative work between LCFT and medicines Management leads. Local pathways and patient safety were taken into consideration.
Recommendation
LSCMMG Recommendation:
Amber level 0
Reason for decision:
Suitable for GP prescribing following recommendation/initiation by specialist
Supporting documents: