MHRA advice for all AEDs

Question 1

risk of suicidal thoughts and behaviour

Answer 1

all antiepileptic drugs may be associated with a small increased risk of suicidal thoughts and behaviour; symptoms may occur as early as 1 week after starting treatment.
seek medical advice if any mood changes, distressing thoughts, or feelings about suicide or self-harming develop, and that the patient should be referred for appropriate treatment if necessary.
Patients should also be advised not to stop or switch antiepileptic treatment and to seek advice from a healthcare professional if concerned.

Question 2

a patient has suicidal thoughts. you look at their PMR and they take pregabalin, not for epilepsy. what do you do

Answer 2

All AEDs have the potential to cause suicidal thoughts and behaviour
Refer to GP
Do not stop treatment

Question 3

Switching between different manufacture products

Answer 3

3P and 1C must be maintained on specific brand
Carbamazepine, phenobarbital, phenytoin, primidone.

Question 4

valproate - full pack dispensing - is it for females only?

Answer 4

Pharmacists are advised that all patients (male and female) must receive their valproate medicines in the manufacturer’s original full pack (i.e. original pack dispensing) and the amount dispensed must be as close as possible to the amount stated on the prescription (NHS or private)

Question 5

latest data on valproate - who can it be started in & is it just for epilepsy indications

Answer 5

• do not start in new pt aged under 55 unless 2 specialists independently agree that there is no other effective or tolerated treatment, or there are compelling aeons why the reproductive risks do not apply
• at next annual specialist review, females of CBP to be reviewed using new risk acknowledgement form which will include the need for a 2nd specialist signature if pt is to continue
• subsequent annual reviews with ONE specialist should be carried out
• FOR ALL INDICATIONS not just epilepsy

Question 6

MHRA - valproate and vitamin D

Answer 6

The MHRA advises consider vitamin D supplementation in patients that are immobilised for long periods or who have inadequate sun exposure or dietary intake of calcium.