USA. Pharmacia & Upjohn Company, in association with the US FDA is informing healthcare professionals about seven post marketing reports of fatalities associated with the use of growth hormone in paediatric patients with Prader-Willi syndrome. These patients had one or more of the following risk factors including severe obesity, history of respiratory impairment or sleep apnoea, or unidentified respiratory infection. In view of these observations the Contraindications section now warns that growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. The package insert also warns about the reports of fatalities in paediatric patients with one or more of the above mentioned risk factors. The warnings section also informs that male patients (with one or more risk factors) may be at greater risk. Patients with Prader-Willi syndrome should be evaluated for upper airway obstruction before initiation of treatment and treatment with growth hormone should be discontinued if airway obstruction develops during treatment. All patients with Prader-Willi syndrome should have effective weight control, evaluated for sleep apnoea and monitored for signs of respiratory infections.
‘Dear Healthcare Professional’ letter from Pharmacia EndocrineCare, 30 May 2003. Available from URL: http://www.fad.gov