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FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
Date:1/29/2010

t utilizes a new technology called DiffCORE™, discovered and developed by GlaxoSmithKline. This allows a controlled release of the medicine in the acidic environment of the stomach, leading to a gradual release of lamotrigine into the bloodstream.

Safety Information

Prescription Lamictal XR Extended-Release Tablets are not for everyone.

Lamictal XR may cause a serious skin rash that may cause the patient to be hospitalized or to stop Lamictal XR; it may rarely cause death. There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when the patient begins taking Lamictal XR, within the first two to eight weeks of treatment. But it can happen in people who have taken Lamictal XR for any period of time. Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking lamotrigine. Lamictal XR is not approved for use in children less than 13 years old.

The risk of getting a rash is higher if the patient: takes Lamictal XR while taking valproate [Depakene* (valproic acid) or Depakote* (divalproex sodium)], takes a higher starting dose of Lamictal XR than a healthcare provider prescribed, or increases the dose of Lamictal XR faster than prescribed.

Lamictal XR can also cause other types of allergic reactions or serious problems which may affect organs and other parts of the body like the liver or blood cells. Patients may or may not have a rash with these types of reactions.

Patients should call their healthcare provider right away if they have any of the following: a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, yellowing of the skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscl
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SOURCE GlaxoSmithKline
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