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FDA Medwatch Alert: Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging

Posted 21 Jul 2014 by Drugs.com

ISSUE: American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This recall is the ...

Epilepsy Drugs in Pregnancy May Affect Infants' Fine Motor Skills

Posted 25 Sep 2013 by Drugs.com

WEDNESDAY, Sept. 25 – Young children exposed to epilepsy drugs in the womb are at increased risk of having impaired fine motor skills, according to a new study. Exposure to the drugs in breast milk, however, does not appear to pose a threat. Researchers looked at data collected from Norwegian mothers about their children's language, behavior, and motor and social skills at the ages of 6 months, ...

Newer Epilepsy Meds Less Likely to Cause Birth Defects: Study

Posted 17 May 2011 by Drugs.com

TUESDAY, May 17 – Newer epilepsy medications don't increase the risk of major birth defects in women taking these drugs during the first trimester of pregnancy, according to new research. But because the drugs are relatively new, further studies are needed to get a clearer picture of their safety profile, experts said. In a large study of children born in Denmark, including those exposed to ...

Epilepsy Drugs Don't Raise Suicide Risk, Study Shows

Posted 5 Aug 2010 by Drugs.com

WEDNESDAY, Aug. 4 – In 2008, the U.S. Food and Drug Administration required epilepsy medications to bear a warning label about an increased risk of suicidal behaviors. The move came after an agency review of 199 studies that found patients taking the drugs showed about twice the risk of suicidal behavior. But now a study of more than 5 million patients contradicts the FDA's findings. It suggests ...

FDA Medwatch Alert: Antiepileptic Drugs

Posted 5 May 2009 by Drugs.com

[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and ...

FDA Medwatch Alert: Trileptal (oxcarbazepine) Tablets and Oral Solution

Posted 19 Apr 2005 by Drugs.com

Novartis Pharmaceuticals and FDA notified healthcare professionals about revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for TRILEPTAL (oxcarbazepine) tablets and oral suspension, indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ages 4-16 years with epilepsy. The updated WARNINGS section describes ...

FDA Adds Suicide Warning to Epilepsy Drugs

Posted 16 Dec 2008 by Drugs.com

TUESDAY, Dec. 16 – The U.S. Food and Drug Administration announced Tuesday that it was adding a label warning on heightened suicide risk for users of antiepileptic drugs. The move, which follows the advice last summer of an FDA advisory panel, stops short of slapping the strongest "black box" warning on this class of drugs, which includes widely used medications such as clonazepam (Klonopin), ...

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Epilepsy, Seizures

Trileptal Patient Information at Drugs.com