Growth Hormone for Prader-Willi Syndrome:  Why Did We Change the Label?

Barbara Lippe, Senior Medical Director, Endocrine Care, Pfizer, Inc., 4929 Wilshire Blvd, Los Angeles, CA  90010. 

May 2003

Dear Health Care Professional,

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:

Long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS).

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:

 CONTRAINDICATIONS:  Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment (see WARNINGS).

WARNINGS:  There have been reports of fatalities with the use of growth hormone in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors:  severe obesity, history of respiratory impairment or sleep apnea, or unidentified respiratory infection.  Male patients with one or more of these risk factors may be at increased risk.  Patients with Prader-Willi syndrome should be evaluated for upper airway obstruction before initiation of treatment with growth hormone.  If during treatment with growth hormone patients show signs of upper airway obstruction (including onset of or increased snoring), treatment should be interrupted.  All patients with Prader-Willi syndrome should be evaluated for sleep apnea and monitored if sleep apnea is suspected.  All patients with Prader-Willi syndrome should have effective weight control and be monitored for signs of respiratory infections, which should be diagnosed as early as possible and treated aggressively (see CONTRAINDICATIONS).

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.

July 2003