Somatropin (Nutropin Depot) Use in Patients With Risk Factors May Result in Fatalities

[Guest guest]

Don't know if anyone has seen this.

Jay

Somatropin (Nutropin Depot) Use in Patients With Risk Factors May Result

in Fatalities

http://www.medscape.com/viewarticle/496537?src=mp

On Oct. 20, the FDA approved revisions to the safety labeling for

somatropin suspension for injection, rDNA origin (Nutropin Depot, made

by Genentech), advising of contraindications and warnings associated

with its use.

Growth hormone such as somatropin is contraindicated in patients with

Prader-Willi syndrome who are severely obese or have severe respiratory

impairment. Somatropin may only be used in the long-term treatment of

pediatric patients with genetically confirmed Prader-Willi syndrome when

the diagnosis includes growth hormone deficiency.

The FDA has received reports of fatalities after the initiation of

somatropin therapy in pediatric patients with Prader-Willi syndrome and

having one or more risk factors, including severe obesity, history of

upper airway obstruction or sleep apnea, and unidentified respiratory

infection. Male sex may confer added risk to those with one or more of

these risk factors.

The FDA recommends that patients with Prader-Willi syndrome be evaluated

for signs of upper airway obstruction and sleep apnea prior to therapy

initiation. Treatment should be interrupted in patients showing signs of

upper airway obstruction (including onset of increased snoring) and/or

sleep apnea.

All patients with Prader-Willi syndrome being treated with growth

hormone should be managed effectively for weight control and monitored

for signs of respiratory infection. The FDA emphasizes the need for

early diagnosis and aggressive treatment of these infections.

Somatropin is indicated for the long-term treatment of growth failure

due to a lack of adequate endogenous growth hormone secretion.