FDA logoIf you have a baby at home then this news could relieve you of a few worries. The U.S food and Drug Administration have permitted the use of Sabril (vigabatrin) which apparently treats infantile spasms in children aged 1 month to 2 years. It is claimed that infants between ages 4 and 8 months are the ones who contract this severe type of seizure that generally appears in the first year of life.

Sabril is claimed to be the first US approved drug to treat this disorder. There disorder includes a frequency of difficult-to-control everyday seizures which can be quite unbearable and weakening for the infant. For adults, to treat complex partial seizures that have not yet responded properly to previous drug therapies, sabril (vigabatrin) tablets are the ones to have been approved in combination with other medications.

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

Infantile spasms are mainly an unexpected bending forward of the body with stiffening of the arms and legs. Some children curve their backs as they expand their arms and legs. Spasms are likely to happen during feeding or awakening and it often occurs in clusters of up to 100 spasms. Every day, infants may have several hundred spasms and dozens of clusters. It is extremely vital that the cause for spasms are identified as several primary disorders such as birth injury, metabolic disorders and genetic disorders can give rise to spasms. Sometimes no cause can be found in some children.

If people have recurring seizures then chances are that they are suffering from epilepsy which is a neurological condition that produces disturbances in the normal electrical functions of the brain. When nerve cells or neurons in the brain send out wrong signals, seizure takes place. People may behave peculiarly or have bizarre sensations or emotions.

With the application of Sabril, damage to vision is an essential safety concern. Apparently the drug has a boxed warning to prepare health care professionals of a progressive danger of loss of marginal vision with a possible reduction in visual acuteness. The peril of vision damage may rise based on the duration of use and dosage, but even the lowest doses of Sabril may cause vision damage. For those taking Sabril, periodic vision testing is necessary. The drug is apparently obtained only through a restricted distribution program as there is always the danger of permanent vision damage.

The FDA selected Sabril as an orphan drug in treating infantile spasms. If a drug is intended to treat a disease or condition that affects less than 200,000 people in U.S, then that drug is suitable for the designation. To encourage the development of a drug to treat a rare disease or condition, the orphan drug status grants the company with financial incentives.

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