Label Changes for:

Forteo teriparatide (rDNA origin) Injection

February 2008

Changes have been made to the ADVERSE REACTIONS sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Reports
    • Muscle spasms, such as of the leg or back, are reported commonly (between 1 and 10 patients per 100 patients treated)...
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