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U.S. Department of Health and Human Services

Safety

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Lupron Depot (leuprolide acetate for depot suspension) and Lupaneta Pack (leuprolide acetate for depot suspension; norethindrone acetate tablets)

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

 

October 2013

Summary View

WARNINGS AND PRECAUTIONS

Convulsions
  • There have been postmarketing reports of convulsions in patients on leuprolide acetate therapy. These included patients with and without concurrent medications and comorbid conditions.

PRECAUTIONS

Information for Patients
  • Convulsions: There have been postmarketing reports of convulsions in patients on leuprolide acetate therapy. These included patients with and without concurrent medications and comorbid conditions.