Join the 'Somatropin' group to help and get support from people like you. How it works
Somatropin Blog
| Tweet |
FDA Medwatch Alert: Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death
Posted 5 Aug 2011 by Drugs.com
[UPDATED 08/04/2011] FDA has determined that, at this time, the evidence regarding recombinant human growth hormone and increased risk of death is inconclusive. In its analysis of the SAGhE study, FDA identified a number of study design weaknesses that limit the interpretability of the study results. FDA also reviewed the medical literature, as well as reports from the Agency's Adverse Event Reporting System (AERS). These additional data sources did not provide evidence suggestive of a link between recombinant human growth hormone and an increased risk of death. Healthcare professionals and patients should continue to prescribe and use recombinant human growth hormone according to the labeled recommendations. FDA is continuing to review this safety issue and expects to receive additional data from the SAGhE study in Spring 2012. FDA will update the public when new information is a ... Read more
Related support groups: Serostim, Saizen, Humatrope, Genotropin, Nutropin, Nutropin AQ, Somatropin, Norditropin, Omnitrope, Accretropin, Tev-Tropin, Norditropin Nordiflex, Zorbtive, HumatroPen, Nutropin Depot
Novo Nordisk Receives FDA Approval for Norditropin FlexPro for Growth Hormone Treatment
Posted 10 Mar 2010 by Drugs.com
PRINCETON, N.J., March 3, 2010 /PRNewswire/ – Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved Norditropin FlexPro (somatropin [rDNA origin] injection), a pre-filled injection pen to be used by children and adults with growth hormone disorders. It will be available in the second quarter. Norditropin FlexPro has a user friendly design which makes it easy to learn and use, and an audible click that confirms that the medication has left the pen. Norditropin FlexPro requires no reconstitution and no loading of cartridges. Norditropin FlexPro is available in 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL pens. After first use, the 5 mg/1.5 mL and 10 mg/1.5 mL pens may be left at room temperature for up to three weeks without risk of spoilage. In a study designed to evaluate the usability of the product, 100 percent of patients found it easy to learn ... Read more
Related support groups: Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency, Norditropin, Somatropin, Turner's Syndrome, Norditropin Nordiflex, Noonan's Syndrome
Ask a Question
Further Information
Related Condition Support Groups
Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency, Turner's Syndrome, Hypopituitarism, Short Stature for Age, Short Bowel Syndrome, Cachexia, AIDS Related Wasting, Idiopathic Short Stature, Noonan's Syndrome, Growth Retardation -- Chronic Renal Failure, Burns, Nitrogen Retention
Related Drug Support Groups
Serostim, Genotropin, Humatrope, Saizen, Nutropin, Nutropin AQ, Norditropin, Omnitrope, Accretropin, Norditropin Nordiflex, Nutropin Depot, Tev-Tropin, Zorbtive, HumatroPen