Lamotrigine ' s chemical structure
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Lamotrigine

Lamotrigine (marketed as Lamictal by GlaxoSmithKline) is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder. For epilepsy it is used to treat partial seizures, primary and secondary tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Lamotrigine also acts as a mood stabilizer. It is the only anticonvulsant mood stabilizer that treats the depressive as well as the manic phases of bipolar disorders, and it is the first medication since Lithium granted FDA-approval for the maintenance treatment of bipolar I. more...

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Chemically unrelated to other anticonvulsants, lamotrigine has relatively few side-effects and does not require blood monitoring. It is a Na+ channel blocker, and is inactivated by hepatic glucuronidation.

U.S. FDA approval history

  • December 1994 - for use as adjunctive treatment for partial seizures with or without secondary generalization in adult patients (16 years of age and older).
  • August 1998 - for use as adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients, new dosage form: chewable dispersible tablets.
  • December 1998 - for use as monotherapy for treatment of partial seizures in adult patients when converting from a single enzyme-inducing anti-epileptic drug (EIAED).
  • January 2003 - for use as adjunctive therapy for partial seizures in pediatric patients as young as 2 years of age.
  • June 2003 - for the maintenance treatment of adults with Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. Additionally, the FDA has noted that findings for Lamictal maintenance treatment were more robust in bipolar depression.
  • January 2004 - for use as monotherapy for treatment of partial seizures in adult patients when converting from the anti-epileptic drug valproate (including valproic acid (Depakene) and divalproex sodium (Depakote)).

Indications & Usage

The FDA approved lamotrigine (Lamictal) for the treatment of epilepsy in 1994, and bipolar I disorder in 2003 (

Lennox-Gastaut syndrome (LGS) is a severe form of epilepsy. Typically developing before 4 years of age, LGS is associated with developmental delays. There is no cure, treatment is often complicated, and complete recovery is rare. Symptoms include the atonic seizure (also known as a "drop attack"), during which brief loss of muscle tone and consciousness cause abrupt falls. Lamotrigine significantly reduces the frequency of LGS seizures, and is one of two medications known to decrease the severity of drop attacks (French et al., 2004). Combination with valproate is common, but this increases the risk of lamotrigine-induced rash, and necessitates reduced dosing due to the interaction of these drugs (Pellock, 1999).

Lamotrigine (Lamictal) is the first FDA-approved therapy since Lithium for maintenance treatment of bipolar I disorder (GlaxoSmithKline, 2003). These are the only true "mood stabilizers" in that they possess antidepressant as well as antimanic properties, and research has shown that of the two, lamotrigine is the more effective treatment for bipolar depression. Traditional anticonvulsant drugs are primarily antimanics. Lamotrigine treats depression without triggering mania, hypomania, mixed states, or rapid-cycling, and the 2002 American Psychiatric Association guidelines recommended lamotrigine as a first-line treatment for acute depression in bipolar disorder as well as a maintenance therapy, however lamotrigine is not indicated "on label" for treatment of acute symptoms.

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No rise in major birth defects with lamotrigine - 10-Year Registry Data
From OB/GYN News, 7/1/03 by Robert Finn

HONOLULU -- A prospective analysis of 10 years of pregnancy registry data has found no evidence that use of the anticonvulsant lamotrigine in the first trimester is associated with an increase in major birth defects, Dr. Mark S. Yerby reported.

Lamotrigine (Lamictal) is classified as Pregnancy Category C as a result of animal studies indicating teratogenic effects and is contraindicated in pregnancy But women with epilepsy often cannot easily be removed from lamotrigine when they become pregnant, he said at the annual meeting of the American Academy of Neurology.

He and his colleagues analyzed data from the GlaxoSmithKline International Lamotrigine Pregnancy Registry They included only women who were enrolled in the registry before the results of their pregnancies became known. The investigators used the Centers for Disease Control and Prevention definition of major birth defects.

Of the 248 qualifying pregnancies involving lamotrigine monotherapy in the registry as of September 2002, six infants had major birth defects. The risk of major birth defects was 2.4%. This compares favorably with general population rates of major birth defects, which range between 2% and 3%, said Dr. Yerby of North Pacific Epilepsy Research, Portland, Ore.

He added that the study was sufficiently powered to be able to detect a 2.05-fold increase in the proportion of major birth defects. Of the six major birth defects seen in this study, no two were alike, and the investigators noticed no pattern. The defects were esophageal malformation, cleft palate, cleft foot, hydronephrosis, anencephaly and atresia of the anus.

The investigators also identified 201 women taking lamotrigine polytherapy during the first trimester of pregnancy Of the 65 women taking lamotrigine polytherapy including valproic acid, 7 had infants (10.8%) with major birth defects. Of the 136 women taking lamotrigine polytherapy but not including valproic acid, 5 had infants (3.7%) with major birth defects.

Dr. Yerby urged physicians with patients who have been exposed to lamotrigine during pregnancy to register these pregnancies either with the GlaxoSmithKline registry (800-336-2176) or with the North American Antiepileptic Drug Pregnancy Registry (888-233-2334), but not both.

COPYRIGHT 2003 International Medical News Group
COPYRIGHT 2003 Gale Group

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