Sabril® (Vigabatrin) – On 1/24/2020 the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application from Lundbeck Pharmaceuticals, to provide for expanded use of Sabril to patients 2 years of age and older with refractory complex partial seizures. Details are in the updated Prescribing Information for Sabril.
Epidiolex (Cannabidiol) – In 2/3/2020, GW Pharma and Greenwich Biosciences submitted a supplemental new drug application to FDA to add tuberous sclerosis complex to the list of rare epilepsies that are indications for use. The addition of more rare epilepsies approved for use is expected to increase.
Valtoco® (Diazepam nasal spray) – On 1/10/2020, FDA approved an application from Neuralis Inc. for a new dosage form (nasal spray) of diazepam. Approved dosage levels are 5 mg, 7.5 mg, and 10 mg. The Prescribing Information provides additional details. When new drugs or dosage forms are approved by FDA, it generally takes several months before those drugs are available in the pharmacies for dispensing. Visit the Valtoco website here for more information on when the drug will be available.
Nayzilam® (midazolam) – On 5/17/19, the FDA approved Nayzilam (midazolam) intranasal spray for the acute treatment of seizure clusters and repetitive seizures that are distinct from the patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. The prescribing information may be found here. Nayzilam became available in pharmacies in late 2019/early 2020. Visit the Nayziliam website here for more information about the drug and savings plans for patients, including co-pay support for those with commercial insurance and support for those insured through federal assistance programs such as Medicaid and Medicare.
SenTiva Vagal Nerve Stimulator (VNS) – On 12/20/19, the FDA announced a recall of the LivaNova VNS Therapy SenTiva Generator due to an unintended reset error that causes the system to stop delivering VNS therapy. This is the model that auto-stimulates based on an increase in heart rate. LivaNova has received 14 reports of unexpected reset errors. 4 patients have required early revision surgery for failed devices. On July 31, 2019, LivaNova implemented additional mitigations and at this time, no reset errors have been observed since the implementation of these mitigations. Please contact your child’s physician if you have any questions as to whether you are affected by this recall.
The FDA has identified this as a Class I recall, the most serious type of recall.
Recalled Product
- Recalled Product: VNS Therapy SenTiva Generator System
- Model Number: 1000
- Distribution Dates:
- Pre-screen Distribution Dates: April 19, 2019 – Sept 30, 2019
- Post-screen Distribution Dates: July 31, 2019 – Current
- Devices Recalled in the US: 2,909
- Date Initiated by Firm: August 22, 2019