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U.S. Department of Health and Human Services

Safety

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Bravelle (urofollitropin for injection, purified)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

February 2014

Summary View

4 CONTRAINDICATIONS

  • Pregnancy…may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]… is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.

5 WARNINGS AND PRECAUTIONS

…Sections updated

  • Ovarian Hyperstimulation Syndrome (OHSS)
  • Pulmonary and Vascular Complications
  • Ovarian Torsion
  • Multi-fetal Gestation and Birth
  • Congenital Malformations
  • Ectopic Pregnancy
  • Spontaneous Abortion
  • Ovarian Neoplasms