FDA Approves Sabril for Infantile Spasms, Adult Epileptic Seizures

Sabril has become the first approved drug for the treatment of infantile spasms, a debilitating disorder that produces frequent and hard-to-control seizures in newborns and young babies, as well as adult seizures caused by epilepsy.

The drug, known chemically as vigabatrin, is approved for treating the spasm condition in children between the ages of one month to two years. Typically, the seizure disorder emerges during the first year of life, most often between four months and eight months, the Food and Drug Administration said.

Sabril Oral Solution is designed for use in newborns and infants. The drug also is approved, in tablet form, for treating complex partial seizures in adults who have not benefitted sufficiently from other, earlier treatments. It is made by Lundbeck Inc. of, Deerfield, Ill.

Epilepsy and infantile spasms cause seizures that can severely reduce nervous system functioning, the FDA said in approving Sabril.

“Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research.

Infantile Spasms, Epilepsy Treatment

Infantile spasms cause the body to suddenly bend forward and the arms and legs to stiffen. Some children suffering from the spasms arch their backs with their arms and legs extended and stiff, the FDA said. The spasms tend to happen just after the child wakes up or eats and may occur in a set of as many as 100 separate spasms.

The spasms may be caused by birth injuries, genetic disorders, or metabolic disorders, but in some cases, the cause of the spasms cannot be identified by doctors, the FDA said. The condition is relatively rare, affecting only one baby out of a few thousand.

Epilepsy is a neurological condition that causes disturbances in the normal electrical functions of the brain. People with the disorder often have recurring seizures, which are triggered when nerve cells, also called neurons, in the brain send out incorrect signals to the body.

Some epileptic seizures result in violent, repetitive movement of the body and sufferers may also experience strange sensations, emotions, and behavior, the FDA noted.

Warning of Vision Damage

Sabril will carry a boxed warning about the risks of damage to vision from taking the drug, the FDA said. There is a risk of progressive loss of peripheral vision and the possibility of reduced visual acuity, which may increase with higher doses or prolonged use of Sabril, the FDA warned. However, even short-term, lower doses of the drug have been found to cause vision damage.

Because of the risks of vision damage from use of Sabril, the drug will only be available through a restricted distribution program, the FDA said.

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