Genotropin (somatropin [rDNA origin] for injection)
July 25, 2003
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]
[April 2003 Full, revised label - Pharmacia]
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