Genotropin (somatropin [rDNA origin] for injection)
Audience: Pediatricians, endocrinologists and other healthcare professionals
Pharmacia and FDA revised the CONTRAINDICATIONS and WARNINGS sections of the prescribing information for Genotropin, indicated for the long-term treatment of pediatric patients who have growth failure. Fatalities have been reported with the use of growth hormone in pediatric patients with Prader-Willi syndrome with one or more of the following risk factors: severe obesity, history of respiratory impairment or sleep apnea, or unidentified respiratory infection. Male patients with these factors may be at increased risk.
[May 30, 2003 - Letter - Pharmacia]