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
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