Sabril to treat spasms in infants and epileptic seizures approved in US

by Anil Kumar



Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years.

Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months.

The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.

Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies.

"Seizures can cause impaired nervous system function and reduced quality of life," said Russell Katz, M.D., director of the Division of Neurology Products at the FDA's Center for Drug Evaluation and Research. "Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option."

Infantile spasms consist primarily of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. Spasms tend to occur upon awakening or after feeding, and often occur in clusters of up to 100 spasms. Infants may have dozens of clusters and several hundred spasms per day. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In some children, no cause can be found.

Epilepsy is a neurological condition that produces disturbances in the normal electrical functions of the brain, causing people to have recurring seizures. Seizures happen when nerve cells, or neurons, in the brain send out the wrong signals. People may have strange sensations and emotions or behave strangely. They may have violent muscle jerking, which may be repetitive, or lose consciousness.

Damage to vision is an important safety concern with the use of Sabril. The drug will have a boxed warning to alert health care professionals to this risk of a progressive loss of peripheral vision with potential decrease in visual acuity. The risk of vision damage may increase based on the dosage and duration of use, but even the lowest doses of Sabril can cause vision damage. Periodic vision testing is required for those taking Sabril. Because of the risk of permanent vision damage, the drug will be available only through a restricted distribution program.

Sabril was designated as an orphan drug by the FDA for use in treating infantile spasms. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. Orphan drug status provides the company with financial incentives to promote the development of a drug to treat a rare disease or condition.

Sabril is made by Lundbeck Inc. of, Deerfield, Ill.


(Anil Kumar -- sub-editor compiled and published Sabril to treat spasms in infants and epileptic seizures approved in US at HealthNewsTrack on August 23, 2009 sourced from U.S. Food and Drug Administration - http://www.fda.gov/)

Epilepsy - recent articles and current news stories:

- Premature birth increases epilepsy risk later in life
- Patterns of medication nonadherence in epilepsy children linked to socioeconomic status
- Drugs for epilepsy increases fracture risk in older
- Pay more attention to epilepsy, affects millions of people
- MMRV vaccine linked to double risk of seizures

Epilepsy article/news source:

Read more health articles from U.S. Food and Drug Administration and health articles from USA.

Epilepsy - search related terms:

Convulsive seizure, Epilepsy, Epileptic seizure, Infant, Infantile spasm, Neurological disorder, Seizure, Spasm,
Epilepsy books,

Subscribe to Health News by Email

List health news, Health organizations, Health news world, Glossary, Best health articles, Featured     Go to top

The information provided on Health Newstrack is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician. We comply with the HONcode principles for trustworthy health information, and Health News Track is hon code accredited, verify here.
About us, Site map Privacy policy, Disclaimer
© 2007, 2008, 2009, 2010, 2011 HealthNewsTrack.com
1.89