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U.S. Department of Health and Human Services

Safety

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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]