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Lähettäjä: Soijuv Lähetetty: 8.12.2004 12:48

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Lääketehdas Pfizer kertoo Genotropin-nimisen kasvuhormonin aiheuttaneen maailmalla 7 kuolemantapausta:


Pfizer warns of deaths linked to growth hormone
July 28, 2003

ST. LOUIS (MD Consult) - In a letter dated May 30, 2003, Pharamacia& Upjohn company, a subsidiary of Pfizer Inc, notified health careprofessionals that its Genotropin growth hormone has been linked to seven deaths around the world. On July 25, the letter was posted on theWeb site of the U.S. Food and Drug Administration (FDA).

As a result, the FDA revised the CONTRAINDICATIONS and WARNINGS sections of the prescribing information for Genotropin.

CONTRAINDICATIONS: Growth hormone is contraindicated in patients with Prader-Willisyndrome who are severely obese or have severe respiratory impairment.

WARNINGS: There have been reports of fatalities with the use of growth hormone inpediatric patients with Prader-Willi syndrome who had one or more ofthe following risk factors: severe obesity, history of respiratory impairment or sleep apnea, or unidentified respiratory infection. Malepatients with one or more of these risk factors may be at increasedrisk. Patients with Prader-Willi syndrome should be evaluated for upperairway obstruction before initiation of treatment with growth hormone.If during treatment with growth hormone, patients show signs of upperairway obstruction (including onset of or increased snoring), treatmentshould be interrupted. All patients with Prader-Willi syndrome shouldbe evaluated for sleep apnea and monitored if sleep apnea is suspected.All patients with Prader-Willi syndrome should have effective weightcontrol and be monitored for signs of respiratory infections, whichshould be diagnosed as early as possible and treated aggressively.

The fatalities were reported with the use of growth hormone inpediatric patients with Prader-Willi syndrome with one or more of thefollowing risk factors: severe obesity, history of respiratoryimpairment or sleep apnea, or unidentified respiratory infection. Malepatients with these factors may be at increased risk.

Pfizer recommended that patients with Prader-Willi syndrome be evaluated,especially for sleep apnea. Persons with questions should contact Pfizer Medical Information at 800-323-4204.