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Lamictal 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 ...

Bipolar Disorder Drug May Need Adjusting in Pregnancy, Study Finds

Posted 6 Nov 2013 by Drugs.com

WEDNESDAY, Nov. 6 – A drug used to treat bipolar disorder becomes less effective during pregnancy, meaning that expectant mothers may require higher doses of the medication, a small new study suggests. Bipolar disorder is a serious mental illness that causes extreme mood swings. Northwestern University researchers looked at eight mothers before and after childbirth. They discovered that blood ...

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, ...

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 ...

FDA Approves Once-A-Day Lamictal XR as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures

Posted 9 Feb 2010 by Drugs.com

RESEARCH TRIANGLE PARK, N.C., Jan. 29 /PRNewswire-FirstCall/ – GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Lamictal XR (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures. This is an expanded label, as Lamictal XR is approved for partial ...

FDA Medwatch Alert: Lamictal (lamotrigine)

Posted 29 Sep 2006 by Drugs.com

[Posted 09/29/2006] The FDA notified healthcare professionals and patients of new preliminary information from the North American Antiepileptic Drug Pregnancy Registry that suggests that babies exposed to Lamictal, indicated to treat seizures and bipolar disorder, during the first three months of pregnancy may have a higher chance of being born with a cleft lip or cleft palate. More research is ...

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 ...

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Related Condition Support Groups

Bipolar Disorder, Epilepsy, Seizure Prevention, Seizure Prophylaxis, Schizoaffective Disorder

Lamictal Patient Information at Drugs.com