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U.S. Department of Health and Human Services

Safety

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Supprelin LA (histrelin acetate) Subcutaneous Implant

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

 

April 2013 

Summary View

 

WARNINGS AND PRECAUTIONS

Implant Insertion/Removal Procedure
  • In some cases the implant broke during removal and multiple pieces were recovered. Confirm that the entire implant has been removed. If the implant was not retrieved completely, the remaining pieces should be removed following the instructions in the Suggested Removal Procedure section
 

ADVERSE REACTIONS

  • Post-marketing Experience: The following adverse reactions have been identified during post approval use of Supprelin LA…

 

April 2012

Summary View

 

ADVERSE EVENTS

Postmarketing Experience
  •  The following adverse reactions have been identified during post approval use of SUPPRELIN LA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.