Thyroid tumors in rats
Both tirzepatide labels carried the FDA’s strongest warning about thyroid tumors seen in rats, and whether tirzepatide causes these tumors in people was not known.
The label barred tirzepatide for anyone who has had medullary thyroid cancer, a rare thyroid cancer, or whose relatives have had it.
It was likewise barred for people with MEN 2, an uncommon condition passed down in families, and for people with a serious allergy to tirzepatide.
