Pharmacy Notice: Co-amoxiclav and valproate
October 26, 2018
Co Amoxiclav Safety Notice:
We have received an anecdotal report from one ward that vials of co-amoxiclav 1.2g injection, once reconstituted, are a yellow/orange colour, unlike the usual clear liquid.
The affected product is a Sandoz brand:
- Batch Number: HK5799
- Expiry: 07/19
This batch and brand is currently in stock across SWBH and pharmacy has not received any other reports from other clinical areas.
Please see drugs safety notice regarding co-amoxiclav 1.2g injection below:
Valproate Safety Notice:
The MHRA have issued an alert in April 2018 about new prescribing and dispensing requirements for all Valproate medicines, commonly used for epilepsy and bipolar disorder, as well as other off label indications. The most commonly dispensed are Epilim and Depakote brands, other brands are available.
Valproate is highly teratogenic and evidence supports that use in pregnancy leads to birth defects in 10 in every 100 babies, (compared to a background rate of 2 to 3 in 100) and neurodevelopmental disorders in approximately 30 to 40 in every 100 children born to mothers taking valproate.
Valproate medicines should therefore no longer be used in women or girls of childbearing age unless a Pregnancy Prevention Programme ‘Prevent’ is in place, irrespective of indication.
This programme will ensure that female patients taking valproate medicines:
- Have been told and understand the risks of use in pregnancy and have signed a Risk acknowledgement Form
- Are on highly effective contraception if necessary
- See their specialist at least every year
This requirement is applicable to all premenopausal female patients, unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Further guidance for healthcare professionals can be found at the following link:
Please see memo regarding valproate below for further details:
If you have any further questions please contact your ward pharmacist, or the Medicines Information Department on ext. 5259.