EMA to Review Safety of Growth Hormone-Based Medicines After Study
The European Medicines Agency will review the safety of medicines containing the growth hormone somatropin after a study suggested an increased risk of death.
The observational study of patients treated during childhood found the risk was greater particularly among patients who took higher-than-recommended doses, the London-based agency said today in an e-mailed statement. The research began in October 2007 in France and examined 7,000 young adults who had been treated with the hormone between 1985 and 1996.
Three somatropin drugs, Roche Holding AG’s Nutropin AQ, Novartis AG’s Omnitrope and BioPartners GmbH’s Valtropin, have been approved by the EMA, and several others were approved by European Union member countries, the agency said. Others on the market include Pfizer Inc.’s Genotropin, Novo Nordisk A/S’s Norditropin, Eli Lilly and Co.’s Humatrope and Merck KGaA’s Saizen and Serostim.
"The review will look into all available data on somatropin to reassess the benefit-risk balance of these medicines," the agency said in the statement.
Phyllis Carter, a spokeswoman for Merck KGaA in Darmstadt, Germany, and Mike Rulis, a Novo Nordisk spokesman, said their companies hadn’t had enough time to review the study and couldn’t comment. Eric Althoff, a spokesman for Novartis, and Alice Spinas, a Roche spokeswoman, also had no immediate comment. A telephone message left for Carole Copeland, an Eli Lilly spokeswoman, wasn’t immediately returned.
Further Studies
The French findings need to be confirmed in further studies, said the agency, which will release more information after its Committee for Medicinal Products for Human Use meets next week.
The hormone, approved by the U.S. Food and Drug Administration in 1995, is used by abnormally small children and by adults with a growth-hormone deficiency. It’s also been used illegally by athletes as a performance-enhancing supplement to build muscle.
Novo Nordisk and Genentech Inc., now part of Roche, warned doctors in 1997 not to use their hormones in certain critically ill surgery patients after Genotropin showed a higher risk of premature death in a study. Doctors had been using it to speed up recovery in patients with a certain metabolic condition.
Genentech and Alkermes Inc. discontinued their long-acting version called Nutropin Depot in 2004 because they said it was too costly to continue making and marketing the product.
To contact the reporter on this story: Allison Connolly in Frankfurt at aconnolly4@bloomberg.net.
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net.
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