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2003 Safety Alert: Genotropin (somatropin [rDNA origin] for injection) |
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The following is the text of a letter from Pharmacia. Contact the company for a copy of any referenced enclosures.PHARMACIA EndocrineCare
May 30, 2003
Pharmacia & Upjohn Company, a subsidiary of Pfizer Inc, would like to inform you about important new safety information pertaining to GENOTROPIN (somatropin [rDNA origin] for injection). GENOTROPIN is indicated for various conditions, including:
Through 1 April 2003, Pfizer is aware of 7 postmarketing reports of fatalities worldwide with the use of growth hormone in pediatric patients with Prader-Willi syndrome. These patients had one or more of the following risk factors: severe obesity, history of respiratory impairment or sleep apnea, or unidentified respiratory infection. In order to communicate this important postmarketing information to health care professionals, the following contraindications and warnings have been added to the package insert with respect to use of GENOTROPIN in the long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome:
Pfizer is committed to the safety of all patients receiving GENOTROPIN. If you have additional questions, please contact Pfizer Medical Information at 800-323-4204. Please see the revised full prescribing information for GENOTROPIN enclosed with this letter. Sincerely, Barbara Lippe, MD
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