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If TAPAZOLE is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be warned of the potential hazard to the fetus.

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Medication: Hyperthyroidism can be treated with the oral drug Tapazol (methimazole).

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Although there have been reports of hepatotoxicity (including acute liver failure) associated with Tapazole, the risk of hepatotoxicity appears to be less with methimazole than with propylthiouracil, especially in the pediatric population.

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Hyperthyroidism are dangerous autoimmune diseases which, if left untreated may cause a Thyroid Storm, a condition that may lead to death.

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The new Boxed Warning and Risk Evaluation and Mitigation Strategy (REMS), are based on FDA's review of post-marketing safety reports of propylthiouracil, as well as meetings held with the American Thyroid Association, the National Institute of Child Health and Human Development, and the pediatric endocrine clinical community.

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