Date approved: January 2000
Status: Prescription only
Approved uses: Anticonvulsant used to control epilepsy and related seizures
Off-Label uses: Used in treatment of bipolar and schizoaffective disorders, neuropathic pain, and obsessive-compulsive disorder (OCD)
• Stevens-Johnson syndrome
• Suicidal Behavior or Ideation
• Birth Defects
Trileptal Lawsuit Information
Trileptal is a drug manufactured by Novartis. It is used to treat epilepsy in adults and children older than four. The drug has been linked to several rare but serious side effects. It can increase a patient�s risk of the serious skin disorder Stevens Johnson syndrome. Trileptal has also been linked to low-sodium levels in the blood. Patients may also experience mood swings, involuntary muscle movements, lack of coordination and a dulled sense of touch, among other more common side effects.
FDA Orders Trileptal Label Change Due to Potential Adverse Side Effects
Trileptal (generic name oxcarbazepine) has been on the market since 2000, and with more than 1 million patients, has been marketed as an effective anti-convulsant and mood stabilizer. But in summer 2005, the FDA ordered that Trileptal change its labeling to warn of potential serious adverse side effects of the popular drug. Why the changes? What are the real dangers of Trileptal use?
Serious Hypersensitivity in Some Patients
The drug, which is manufactured by Novartis Pharmaceuticals and distributed throughout the United States, was found by the FDA to carry with it the risk of severe hypersensitivity reactions for some patients. These reactions include Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), a reaction that affects skin as if it had been scalded. Some of these hypersensitivity reactions were life-threatening; some resulted in death. The risk of developing these symptoms while taking Trileptal is three to ten times larger than that of the non-Trileptal-taking population.
Patients who have had a hypersensitivity reaction while taking Carbamazepine should know that taking Trileptal means they are at a 25% risk of a similar reaction. However, as with other anti-convulsives and epilepsy medications, it is recommended that withdrawal occur under a doctor’s care, since weaning off of the drug may cause a recurrence of epileptic seizures in some patients.
Off-Label Uses for Trileptal
While the drug was created as an anti-convulsant to help patients with epilepsy who experience seizures, the drug has also been prescribed to treat bipolarity and depression, schizoaffective disorder, obsessive-compulsive disorder (OCD) and pain associated with neuropathy. Thus, patients with a wide range of underlying disorders have been exposed to the dangerous side effects of Trileptal. However, the drug still remains on the market to date. Off-label uses are not FDA-approved, but are common in the United States. However, off-label uses are often based on shaky medical evidence and are not backed by the extensive clinical trials that are part of the FDA approval process.
If You’ve Suffered Side Effects
If you or a loved one have suffered side effects from Trileptal use, you may be eligible for monetary compensation for your Trileptal-related disorders. Contact an experienced unsafe drugs lawyer to discuss whether you have a valid claim. Your Trileptal attorney can evaluate your potential claims, file your law suit, and get you compensation for your side effects. Be sure to seek medical attention if you are exhibiting symptoms associated with SJS and TEN, and consult with an experienced attorney who can get you the damages you deserve.
Hyponatremia and Trileptal
Hyponatremia, or “water poisoning”, is a side effect of anti-convulsant and commonly used bipolarity drug Trileptal. The condition, in which excess blood plasma dilutes the salt content of blood, can decrease organ function and endanger the lives of patients taking Trileptal.
Why Trileptal Causes Hyponatremia
Nearly three percent of all patients studied in the clinical trials related to Trileptal experienced hyponatremia during treatment compared to placebo patients. While most patients were asymptomatic, some experienced full-blown water poisoning which required hospitalization. This nearly always resolved once Trileptal was discontinued in these patients. Trileptal causes chemical reactions within the body that reduce serum sodium, diluting the salt content of the blood and causing a disruption in the electrochemical balance of the nervous system. Symptoms of hyponatremia include confusion, fatigue, nausea, malaise, and the potential for increased seizures – exactly the symptoms that Trileptal claims to help conquer.
Treatment of Hyponatremia
If you are taking Trileptal and experience symptoms of hyponatremia, get medical assistance immediately. Failure to seek immediate medical care may cause further worsening of the hyponatremia symptoms and could lead to shock, coma or death. You should go to a doctor’s office or emergency room. You will probably be placed on an intravenous (IV) drip to help restore the electrolyte and salt balance in your bloodstream. Tell your doctor that you are taking Trileptal in order to help him or her determine the best course of action. This could vary depending on your dosage of and dependence on Trileptal; your doctor may need to wean you off of the drug gradually in order to prevent a worsening or recurrence of seizures.
If You’ve Experienced Trileptal Side Effects
Other dangerous Trileptal side effects, including extreme skin hypersensitivity reactions such as Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), have been noted in some Trileptal patients. If you think your health has suffered or is suffering because of your use of this popular anti-convulsant, contact a doctor immediately. You may wish to consult with an experienced unsafe drugs attorney who can evaluate your case and tell you whether you have a valid claim. Your Trileptal lawyer will walk you through the litigation process and help you receive the monetary compensation you deserve for your Trileptal-related injuries and conditions.