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The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditionsbut the absolute risk differences were similar for the epilepsy and psychiatric indications.
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ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF TEGRETOLDATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOMEHOWEVERTHE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.
Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac conduction disturbanceincluding second-and third-degree AV heart blockcardiachepaticor renal damageadverse hematologic or hypersensitivity reaction to other drugsincluding reactions to other anticonvulsantsor interrupted courses of therapy with Tegretol.
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