Tev-Tropin (somatropin [rDNA origin]) for injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011
- Cases of pancreatitis have been reported rarely in children and adults.....
- Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome,” (characterized.....
- Treatment with somatropin may decrease insulin sensitivity....
- New-onset type 2 diabetes mellitus has been reported
- potential immunogenicity of therapeutic proteins