Epilim and Epanutin drug shortages
This article was last updated on the 29/10/2018
There is currently a supply issue with Epilim Chronosphere (sodium valproate) 250mg Modified Release Granules which is likely to last until the end of November and there is likely to be a shortage of Epanutin (phenytoin) oral suspension from the end of October through to December.
Epanutin (phenytoin) shortage
We have been advised by the pharmaceutical company Pfizer that there is likely to be a shortage of Epanutin (phenytoin) oral suspension from the end of October through to December. The chewable and injectable versions of the medication are not affected.
The Department of Health and Social Care (DHSC) has informed us that they are doing everything they can to ensure that people who rely on the oral suspension will still be able to access appropriate medication. DHSC has issued guidance with input from neurology and patient safety experts via the MHRA’s Central Alerting System (CAS). The guidance advises all GPs to contact patients who have been prescribed the Epanutin oral suspension, so that they can assess whether they have an adequate supply to see them through until new stock arrives in December. If the patient does not have an adequate supply, it will be essential to ensure that they are prescribed an alternative phenytoin product.
To help mitigate the shortage, Pfizer has obtained approval from the Medicines and Healthcare Regulatory Agency (MHRA) to import stock of phenytoin oral suspension from Canada. This stock is considered an unlicensed preparation in the UK. It is important to note that supplies of this product are very limited and therefore it may not be possible to access for all patients. Other unlicensed phenytoin suspensions are also available and your doctor will be able to advise you further on the most appropriate phenytoin product for you.
It is important that anyone who is taking Epanutin has a consistent supply of the medication. However, all product switches should be closely monitored by your doctor to check that the concentration of the drug in your blood is at the correct level.
A spokesperson for DHSC said, ‘We are aware of the impending shortage of Epanutin 30mg/5ml oral suspension and have issued comprehensive guidance to Health Care Professionals about how to manage patients who may be affected by this shortage’
What you should do if you are taking Epanutin oral suspension
If you are currently taking Epanutin oral suspension, your GP should contact you. However, rather than wait you should check whether you have enough supplies to last until early December. If you don’t, you should discuss changes in your treatment with your GP or specialist doctor (such as a neurologist) as soon possible. Any changes in your treatment due to the shortage should be managed by a specialist.
If you need to switch to a different version of the drug, your serum levels should be properly monitored on a regular basis to make sure you have the correct amount of the drug in your blood.
Around 6,000 bottles of Epanutin oral suspension are dispensed every month in the UK and it is estimated that the numbers of people prescribed the medication is between 4,000 and 6,000. The shortage of supply is due to a delay by third party manufacturers in France.
If you are taking Epanutin oral suspension and would like to talk to someone about this, please call our Helpline on 01494 601400 (Mon and Tues 9am-4pm and Wed 9am-7.30pm).
Epilim Chronosphere (sodium valproate) shortage
We have been informed by the pharmaceutical company Sanofi that they are experiencing a supply issue with Epilim Chronosphere (sodium valproate) 250mg Modified Release Granules, which is likely to last until the end of November. All other forms of Epilim, remain available, and sodium valproate is also available from other manufacturers.
What you should do if you are taking Epilim Chronosphere 250mg Modified Release Granules
If you are currently taking Epilim Chronosphere 250mg and are likely to run out of your medication before the end of November, you should make an appointment with your GP or specialist doctor (such as neurologist) as soon as possible.
Your GP or specialist may suggest you take Epilim liquid or syrup in the meantime and discuss the correct dose for you. Your pharmacist can also discuss alternatives, or they can contact Sanofi’s customer service team to help resolve any issues. It is important that any changes in your treatment due to the shortage are managed by a specialist.
The shortage of supply is due to temporary disruption of valproate at Sanofi’s manufacturing site in France.
If you are taking Epilim and would like to talk to someone about this, please call our Helpline on 01494 601400 (Mon and Tues 9am-4pm and Wed 9am-7.30pm).
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