Label Changes for:
Ovidrel (choriogonadotropin alfa injection) prefilled syringe
June 2010
Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2010
WARNINGS
The risks of gonadotropin treatment should be considered for women with risk factors of thromboembolic events such as prior medical or family history.
ADVERSE REACTIONS
- Post-marketing Experience Cases of allergic reactions, including anaphylactic reactions and mild reversible skin rashes have been reported in patients treated with Ovidrel since market introduction. The causal relationship is unknown.
- Thromboembolic events both in association with, and separate from, the Ovarian Hyperstimulation Syndrome
