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U.S. Department of Health and Human Services

Safety

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Lumizyme (alglucosidase alfa)

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

  

May 2014

Summary View

6 ADVERSE REACTIONS

6.3 Postmarketing Experience...section updated

 

July 2012

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • abdominal pain, nephrotic syndrome and proteinuria, as observed events to the package insert