Bipolar disorder tablets to be discontinued
Priadel 200mg and 400mg modified release tablets are to be discontinued, with all remaining supplies expected to run out by April of next year.
The product is a first-line treatment for patients with bipolar disorder, and is also licensed for the treatment and prophylaxis of recurrent depression and aggressive or self-harming behaviour. It is also used off-licence in the treatment of cluster headaches.
Manufacturer Essential Pharma said that “restrictions on permitted pricing” meant it was “no longer viable” to produce the tablets.
The MHRA issued a supply disruption alert (SDA) on Friday explaining that while other brands of lithium carbonate are available, including Camcolit and Liskonum, switching patients from Priadel will “require individualised determination of dose, close monitoring of serum lithium levels and vigilance for relapse and tolerability in all cases”.
This is because clinical guidance states that patients should be maintained on the same brand of lithium to maintain consistent serum lithium levels.
The SDA states that all patients being switched from Priadel to another lithium formulation should have tailored management plans, and that prescribers should seek to involve patients or their carers in the decision making process.
The announcement does not affect supplies of Priadel 520/5ml liquid preparation, though pharmacy teams are reminded that this contains lithium citrate rather than lithium carbonate.
“If prescribers deem a switch to a liquid formulation appropriate, relevant guidance should be consulted to ensure safe switching,” according to the SDA.
The Royal College of Psychiatrists issued a statement on August 3 saying it was aware that Essential Pharma was planning to stop producing the tablets, an that it was working with the Department of Health and Social Care and NHS services to develop guidance for clinicians and patients.