July 3, 2003: Humatrope (somatropin rDNA origin) for injection vials and Cartridges for use with the HumatroPen Injection Device
The FDA has issued an alert for patients with Turner syndrome taking Humatrope. According to clinical trials, Humatrope has been associated with middle ear inflammation and other ear disorders. To read the updated warning label, click here:www.fda.gov/medwatch/SAFETY/2003/03Jul_PI/Humatrope_PI.pdf August 12, 2003: Genotropin brand of somatropin [rDna origin] for injection
The FDA has issued new warnings that say the drug should not be used by patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. To print out the entire document here for a discussion with your doctor, click here. www.fda.gov/medwatch/SAFETY/2003/Oct03.htm - 08-12-2003 - Cached May, 2003 New safety alert warning pertaining to somatropin [rDNA origin]
A "Dear Doctor" letter written May, 30, 2003 by Pfizer medical director, Barbara Lippe, MD, announced that new safety information had been added to the package insert for GENOTROPIN (somatropin [rDNA origin] for injection). Genotropin is manufactured by Pharmacia &Upjohn, a subsidiary of Pfizer, Inc. The warning pertains to pediatric patients with Prader-Willi Syndrome (PWS). The following contraindications and warnings have been added to the package insert: "CONTRAINDICATIONS: Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. 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." For more information, contact Pfizer Medical Information at 800-323-4204 or the FDA¹s MedWatch program at 800-FDA-1088.
First published December 15, 2003
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