Associate Professor of Neurology
The Ohio State University College of Medicine Division
Director of Epilepsy and
Director of Neuromodulation for Epilepsy
The Ohio State University Wexner Medical Center
Columbus, OH
Danielle Becker, MD, MS, FAES, is an adult epileptologist and the Division Director of Epilepsy and an Associate Professor of Neurology at The Ohio State University Wexner Medical Center. She has managed a wide variety of patients with epilepsy, on both the inpatient and outpatient level. She is well versed in anti-seizure medication management, as well as surgical and neuromodulation management. She has an additional interest in epilepsy and women and has created specialty pregnancy clinics for patients who are pregnant with epilepsy. She also continues her research interest in the assessment and management of response to implanted neurostimulation devices in subjects with epilepsy and is the Director of Neuromodulation at The Ohio State University Wexner Medical Center.
Dr Becker completed 2 years of neurophysiology/epilepsy fellowship—first at the Hospital of the University of Pennsylvania, second at the NYU Medical Center. She then served as an Assistant Professor of Clinical Neurology at the Hospital of the University of Pennsylvania from 2014 to 2020. She was the Director of the Responsive Neurostimulation System Program for Surgical Management as well as Head of Epilepsy Education at the University of Pennsylvania. She was also the Associate Program Director of both the neurology residency and neurology medical student clerkship and Assistant Director of the Epilepsy Fellowship Program. She then moved to become the Medical Director of Epilepsy at MetroHealth in Cleveland, Ohio, where she started an epilepsy program for the underserved community from 2020 to 2023.
Dr Becker is board certified in both neurology and epilepsy by the American Board of Psychiatry and Neurology and is a member of the American Academy of Neurology and the American Epilepsy Society.
TERMS AND CONDITIONS
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VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.
IMPORTANT SAFETY INFORMATION
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
Contraindications: VALTOCO is contraindicated in patients with:
Central Nervous System (CNS) Depression
Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits.
The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner.
Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior.
Glaucoma
Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.
Neonatal Sedation and Withdrawal Syndrome
Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly.
Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative
VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including “gasping syndrome,” can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.
Adverse Reactions
The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.
Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.
To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
Please read full Prescribing Information, including Boxed Warning, for additional important safety information.
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