Due to production problems of Sabril 500 mg, a medicinal product used for epilepsy, there has been a critical shortage in Belgium since February 21, 2023. A task force is making recommendations.
Due to a delay in production, Sabril has been temporarily unavailable since February 21, 2023. The expected end date of the unavailability is July 1, 2023. The FAMHP created a task force to work with experts in order to find solutions. The task force makes recommendations to (hospital) pharmacists, physicians(-specialists) and patients.
Recommendations for (hospital) pharmacists and physicians(-specialists)
- In new pediatric patients with West syndrome, first-line adrenocorticotropic hormone (ACTH) or corticosteroids may be used. Patients whose symptoms are not controlled with this treatment, may be treated second-line with Sabril 500 mg.
- In pediatric patients with refractory epilepsy without West syndrome or without a diagnosis of tuberous sclerosis (TSC), Sabril is not indicated because of the possible side effects on the retina.
- Given the critical shortage, an already initiated treatment with Sabril should be phased out earlier and faster whenever possible.
- In adult patients with focal epilepsy, Sabril is a medicinal product of last choice, due in part to its potential side effects on the retina.
- Treatment with Sabril cannot currently be initiated in patients with refractory focal epilepsy. They are best treated with other, newer antiepileptic medicinal products such as those based on lacosamide, brivaracetam and cenobamate.
- Given the critical shortage, an already initiated treatment with Sabril should be phased out earlier and faster whenever possible. The usual tapering schedule of 500 mg per week can be accelerated to 1000 mg per week if necessary.
Absolute priority must be given to :
- pediatric patients with West syndrome and tuberous sclerosis (TSC) in whom a previous tapering schedule of Sabril led to relapse;
- pediatric patients with West syndrome in whom ACTH or corticosteroids are ineffective.
Due to the very limited remaining stock of Sabril, an accelerated tapering schedule is possible in a subset of patients. Tapering can be started with the amount still available in the patient's supply. It is important to reach these patients before their supply of Sabril is depleted. Patients are urged to contact the treating (pediatric) neurologist to find out if and how to gradually reduce the Sabril dosage.
We ask pharmacists, when a patient presents himself at the pharmacy with a medical prescription for Sabril, to inform and raise awareness of that patient to contact the treating (pediatric) neurologist as soon as possible in order to determine if and how the Sabril dosage can be gradually reduced. At the patient's request, the pharmacist himself may contact the (pediatric) neurologist to determine if and how the Sabril dosage can be gradually reduced.
Recommendations for patients
For pediatric and adult patients currently being treated with Sabril, tapering should be considered given the critical shortage of Sabril, unless Sabril is indispensable for epilepsy control. It is essential that you contact the treating (pediatric) neurologist for this purpose. He knows the medical background and is best placed to inform the patient whether a tapering schedule is necessary. The (pediatric) neurologist will also brief the patient on how to gradually reduce the medication. Treatment with Sabril should never be discontinued on one's own initiative.
It is very important that you contact your treating (pediatric) neurologist as soon as possible, preferably before your home supply of Sabril is completely depleted. Consultation will then be held to see if a phase-out is possible with the stock of Sabril available at home.
If the patient runs out of Sabril, the treating (pediatric) neurologist should be contacted immediately. The pharmacist will also remind you of this when you go to the pharmacy with a medical prescription. If you wish, the pharmacist can contact the (pediatric) neurologist to determine if and how the Sabril dosage can be gradually reduced.
The list of unavailable medicines is available on PharmaStatus, the FAMHP's application that collects information about the availability of medicines in Belgium. Here you can look up information about unavailabilities (reason, duration, impact). You can be notified of any changes in the availability of Sabril 500 mg, by using the "keep me informed" button in PharmaStatus.
The very limited remaining stock at the company is being prioritised for hospitals, where new patients with infantile spasms in West syndrome present themselves. The FAMHP and physicians-specialists are in contact for this purpose.
The FAMHP is closely monitoring the situation.