Somatonorm post-marketing surveillance study (UK and Ireland, 1986-1987): a preliminary report

A PMS study in the UK and Ireland recruited 581 children, mainly with GH deficiency, for treatment with Somatonorm and observation for 1 year; only 1 child proved totally non-evaluable. The mean dose prescribed was 0.41 IU/kg/week, with 56% of children receiving below the recommended dose. Underdosing was reflected particularly by the low growth rates of pubertal children. Somatonorm was safe, with a low incidence of reported events, of which lipoatrophy (in 6 cases) was the most common. Antibody assays were seldom requested and always negative.