The rosiglitazone decision process at FDA and EMA. What should we learn?
Pouwels K., Van Grootheest K.
In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of ischemic heart disease. Remarkably, in 2007, when the evidence against the combination of rosiglitazone and insulin had increased, the EMA made a decision that encouraged the use of insulin in combination with rosiglitazone, while the FDA tried to restrict this combination therapy. Despite the publication of several studies, including a large randomized controlled study, the cardiovascular risk of rosiglitazone has still not been definitively established. To prevent new cases like rosiglitazone, more attention should be given to evaluation of study protocols of safety trials prior to their start. The rosiglitazone story further underlines the critical importance of publicly available trial data.