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Injured by Trileptal?

Trileptal (Generic: Oxcarbazepine) is an antiepileptic drug that has been approved by the U.S. Food and Drug Administration and is indicated for use as monotherapy (by itself) or adjunctive therapy (taken with other medications) in the treatment of partial seizures in adults and children 4 years of age and older with epilepsy.

Novartis Pharmaceuticals and the FDA notified healthcare professionals about revisions to the warnings and precautions sections of the prescribing information for Trileptal tablets and oral suspension. The updated warnings section describes serious dermatological reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), that have been reported in both children and adults in association with Trileptal use. The PRECAUTIONS section has been updated to include language regarding multi-organ hypersensitivity reactions that have been reported in association with Trileptal use.  Trileptal has been available in the United States since February 2000, and has been prescribed for over 250,000 patients. In 2004, sales of Trileptal totaled $391 million.

If you or a loved one took Trileptal and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
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Epilepsy Drugs Targeted for Black Box Suicide Warning

Jul 8, 2008 | Parker Waichman Alonso LLP
Federal regulators want the makers of epilepsy drugs to add a black box warning to their labels about their association with suicidal thoughts and behavior. The Food & Drug Administration (FDA) is set to ask an outside advisory panel for its recommendations on the proposed black box at a meeting this Thursday.   In total, 11 epilepsy drugs could get the new black box warning - the FDA's strongest safety notice. They include:Carbamazepine (marketed as Carbatrol, Equetro, Tegretol,...

Epilepsy Drugs to Get Suicide Warnings, FDA Confirms

Jun 6, 2008 | Parker Waichman Alonso LLP
US regulators are very close to finalizing new suicide warnings for 11 epilepsy drugs, The Wall Street Journal reported today.  This past January, the Food & Drug Administration (FDA) issued an Early Communication announcing a safety review of the epilepsy drugs after a study showed they increased patients' risk of suicidal thoughts and behavior. The 11 epilepsy drugs slated for a new suicide warning are: Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)...

Epilepsy Drug No Help Against Migraines

Feb 12, 2008 | Parker Waichman Alonso LLP
The epilepsy drug oxcarbazepine was strongly believed to have prevented migraine headaches; however, a new study suggests that this is not so.  Epilepsy drugs such as oxcarbazepine have long been used for migraine prevention, according to Dr. Stephen Silberstein of the Jefferson Headache Center in Philadelphia and associates.  Oxcarbazepine—marketed as Trileptal by Novartis or Trexapin by Taro—is used alone or in combination with other medications to treat certain types of...

Epilepsy Drugs Double Suicide Risks, FDA Warns

Feb 2, 2008 | Parker Waichman Alonso LLP
Epilepsy drugs have been linked to a increased risk of suicidal thoughts and behavior, the Food & Drug Administration (FDA) warned this week.  According  to an FDA analysis, people taking antiepileptic drugs are twice as likely to experience suicidal thoughts or behavior than those taking placebo.The FDA began investigating if epilepsy drugs pose any suicide risk in 2005.  In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the...

FDA panel to review safety of 16 drugs in children

Nov 15, 2006 | www.cbsmarketwatch.com
A Food and Drug Administration panel is set to meet Thursday to discuss the safety review of 16 drugs, including flu drug Tamiflu, in pediatric patients. The pediatric advisory committee will evaluate new and updated reports by the FDA staff that include information on the drugs' safety compiled over a year. The panel will then make recommendations that could include label changes or further investigation of adverse events. The FDA isn't required to follow the panel's suggestions, but it...

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