P&U Calls Halt To Off-Label Use Of Genotropin

Pointing to the mortality rate in two European Phase III trials of itshuman growth hormone product Genotropin (somatropin) for the treatment of acute catabolism, Pharmacia & Upjohn has sent a letter to health care professionals to end off-label use of the drug in this indication. In its "Dear Doctor" letter, the company recommends that "further use of recombinant somatropin for acute catabolism....be stopped immediately."

The trials were being run for an additional adult indication for the product. However, for the two studies combined, the mortality rate was 18.2% in placebo-treated patients and 41.7% in the somatropin-treated group, the letter said.

The company stressed, however, that more than 10 years of clinical experience and extensive data provided by large trials and long-term follow-up programs have shown that the product is safe in its approved indication, the treatment of adults and children with growth hormone deficiency. Genotropin received marketing clearance for this indication in the USA (Marketletter November 17).