Trileptal – An Overview

Trileptal is used for the treatment of epilepsy in children above four years of age and adults. Novartis manufactures it. Trileptal has been associated with many rare but severe side effects. Use of this drug increases the patient’s risk of developing a skin disorder called Stevens Johnson syndrome. This drug also lowers the level of sodium in the blood. Common side effects associated with the use of Trileptal includes lack of coordination, mood swings, dulled sense of touch and involuntary movement of muscles.

Trileptal, an Anti Epileptic Medication

The U.S. Food and Drug Administration approved Trileptal for the partial seizures among the adults and children suffering from Epilepsy. Novartis Pharma Corporation manufactures Trileptal. It has been approved for adjunctive therapy and immunotherapy. Additionally it is prescribed as off the label drug for the treatment of mood disorders.

Trileptal was approved by FDA in 2000 and since than it has been prescribed to more than a million patients. Since 1990, Trileptal was available in the International market. In October 1995, FDA reviewed the warning on all Trileptal labels and approved it for prescribing it to children above the age of two. Trileptal was the first Epilepsy drug approved for immunotherapy among children.

Epilepsy is a brain disorder. It is a condition occurring on the disruption of electrical signals in the brain. This disturbance in the brain causes seizures. Seizures cause changes in a person’s awareness, senses (like vision, taste, hearing or smell), body movements and emotions. In most of the cases, seizures occur unpredictably and randomly. At times, “triggers” are responsible for seizures. Individuals should be aware of triggers and methods to avoid them. Triggers can be general as well as person specific in nature.

Novartis, manufacturers of Trileptal claims that the drugs do not cause severe side effects like other antiepileptic medications such as changes in facial features, weight gain and unusual hair growth.

Common side effects occurring in the patients using Trileptal includes the following:

• Sleepiness
• Fatigue
• Vomiting
• Abnormal vision
• Tremors
• Abnormal gait
• Dizziness
• Double vision
• Nausea
• Discoordination
• Abnormal pain
• Indigestion

Moreover, Trileptal causes low level of serum sodium in the blood. Symptoms of low levels of sodium include discomfort and drowsiness, confusion, nausea, headache or dullness.

Trileptal increased the risk of skin reaction called Stevens Johnson Syndrome (SJS). It is a serious and fatal inflammatory disease. A patient develops ulcerated lesions on the mucus membrane and skin in this condition. In April 2005, FDA asked the manufacturers of Trileptal to change the warning label of the drug. The new warning label should highlight side effects of Stevens Johnson Syndrome and another rare skin disease, Toxic Epidermal Necrolysis (TEN).

Novartis Pharmaceuticals issued a “Dear Health Care Professional” letter to the doctors informing them about the side effects associated with Trileptal. Doctors should use this new updated information while writing prescriptions. They are further expected to share important information with the patients.