In clinical trials, the most common side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection site reactions. The FDA advices that Tanzeum should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or as first-line therapy for patients who can’t be managed with diet and exercise.
The FDA is also requiring a Boxed Warning for Tanzeum to warn that tumors of the thyroid gland have been observed in rodent studies, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC).
To learn more, the FDA is requiring the following post-marketing studies for Tanzeum:
- a clinical trial to evaluate dosing, efficacy, and safety in children;
- a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum;
- a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.
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