Shortage of Epanutin® (phenytoin) 30mg/5ml oral suspension
We have been advised by the pharmaceutical company Pfizer that due a supply disruption, there will be a shortage of Epanutin® (phenytoin) 30mg/5ml oral suspension from 9 June 2019. This is expected to be ongoing until the end of July 2019.
Under guidance issued by the Medicines and Healthcare products Regulatory Agency, it is important that anyone who is taking Epanutin has a consistent supply of the medication and ideally should not be switched to a different version of the same drug.
Any switches to different preparations must be managed under medical supervision and may require monitoring of phenytoin serum levels.
To ensure that there is still a supply of phenytoin for those who take the medication, Pfizer is importing phenytoin oral suspension from Canada.
Phenytoin from Canada
The Canadian phenytoin oral suspension is labelled as Dilantin-30 and is supplied in 250ml bottles containing 30mg/5ml phenytoin.
Both suspensions are similar in colour, taste and concentration of the active ingredient (phenytoin), therefore no dosing adjustments should be necessary. However some of the non-active ingredients are different and dosing information on the Canadian Patient Information Leaflet (PIL) is different to the Epanutin PIL. People should remain on their prescribed dosage and should consult their doctor if they are unsure.
Safety is a priority
A spokesperson for Pfizer said: "Patient safety is of the utmost priority to Pfizer and we are keenly aware of the importance of the supply of Epanutin® (phenytoin) 30mg/5ml oral suspension to patients. We work very hard to avoid medicines shortages but, despite our best efforts, unexpected delays can occur for which we sincerely apologise."
Supplies for Epanutin Infatabs are also lower than usual and Pfizer is already importing unlicensed Canadian Dilantin (phenytoin) Infatabs to manage this issue.
The company has stressed that people should not be switched to Epanutin Infatabs or unlicensed Dilantin Infatabs as this may lead to further shortages of this presentation. Additionally, Pfizer does not hold bioequivalence data for switches between the two products.
Central alerting system
The MHRA has issued a notification to healthcare professionals about the shortage via its central alerting system.
Find out more about how to cope with current medication shortages by reading the advice from our medical director, Professor Ley Sander.
Call our Helpline
If you are taking Epanutin® (phenytoin) 30mg/5ml oral suspension and are feeling anxious about this change, please call our Helpline on 01494 601400 (Mon and Tues 9am-4pm and Wed 9am-7.30pm).
Or you can call Pfizer's Customer Contact Centre for queries about product availability, call 0845 608 8866.