Label Changes for:
Norditropin Cartridges [somatropin (rDNA origin) injection], for Subcutaneous Use
October 2008
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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. Read about the new physician labeling format . |
| Sections Modified |
Summary of Changes to Contraindications and Warnings |
|
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
PATIENT PACKAGE INSERT
INSTRUCTIONS FOR USE (see highlighted PATIENT PACKAGE INSERTS for new text). |
CONTRAINDICATIONS Prader-Willi Syndrome in Children ...There have been reports of sudden death when somatropin was used in such patients [see Warnings and Precautions (5.2)]. Norditropin is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. WARNINGS AND PRECAUTIONS Prader-Willi Syndrome in Children ...Norditropin is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. |
