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Lamictal XR News

FDA Medwatch Alert: Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

Posted 26 Apr 2018 by Drugs.com

ISSUE: The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are r ...

FDA Medwatch Alert: Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards

Posted 31 Aug 2016 by Drugs.com

ISSUE: Impax Laboratories, Inc. issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg, NDC 0115-1529-08, Lot # 502240. The affected lot was distributed between June 13, 2016 and August 10, 2016 to wholesale distributors and retail pharmacies nationwide.  Unit-of-use blister packs (a 10 count blister card contained ...

Study Sees No Link Between Common Epilepsy Drug, Certain Birth Defects

Posted 6 Apr 2016 by Drugs.com

WEDNESDAY, April 6, 2016 – Despite initial concern from early studies, taking the epilepsy drug lamotrigine (Lamictal) during pregnancy may not raise the risk for certain birth defects, a large new study finds. "An initial study of this drug showed an increased risk for cleft lip or cleft palate, but a number of other studies since have not, and our previous study showed an increased risk of ...

FDA Approves Lamictal XR (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients

Posted 28 Apr 2011 by Drugs.com

RESEARCH TRIANGLE PARK, N.C., April 25, 2011 /PRNewswire/ – GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Lamictal XR (lamotrigine) Extended-Release Tablets for conversion to monotherapy in patients 13 years and older with partial seizures taking one anti-epileptic drug. This is a new indication for Lamictal XR which is already approved as ...

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Related Condition Support Groups

Seizure Prevention, Seizure Prophylaxis, Epilepsy

Lamictal XR Patient Information at Drugs.com