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Safety concerns over GSK's Avandia
25 May 2007
GlaxoSmithKline (GSK) is fighting for the reputation of its second best-selling drug, Type 2 diabetes therapy Avandia (rosiglitazone maleate), after the emergence of meta-analysis data suggesting that it could increase the risk of heart attacks by 43%.
The FDA had already revised the product labelling for the drug in 2006, to include a warning about a potential increase in heart-related chest pain and heart attacks, but the meta-analysis conducted by leading cardiologist, Steve Nissen from the Cleveland Clinic Foundation in Ohio, prompted the FDA to look again at the safety profile. Nissen and his co-author Kathy Wolski, reviewed 42 trials all listed in the public domain, and concluded that Avandia may raise a patient's risk of heart attack by 43% and increase the risk of death from all cardiovascular causes by 64%.
GSK strongly disagrees with the report's conclusions, pointing out that comparable rates of cardiovascular deaths were observed in patients receiving Avandia, compared to non-treatment arms, in two of its long-term studies, ADOPT and DREAM. Ronald Krall, GSK's Medical Director, added, "We are confident of the safety profile of Avandia and believe in its benefits for Type 2 diabetic patients."
Despite the view of the FDA, that the risks of Avandia are not yet clear, the share price is already down by 8%, with analysts predicting a 35% fall in Avandia sales due to negative publicity. The FDA is currently conducting its own analysis and plans to take the data to an advisory committee meeting as soon as possible.
