At the time of the initial marketin

At the time of the initial marketing authorisation (MA), the CHMP was satisfied with the short-term safety of rosiglitazone, but the available data on long-term safety was at the time considered to be limited. However, additional studies looking at more sensitive functional parameters to detect early onset of cardiac injury as well as studies evaluating the potential of rosiglitazone to affect cardiovascular morbidity and mortality in diabetes patients during long-term therapy were required. The CHMP therefore only granted a second line indication as add-on to MET or SU. A contraindication for use of rosiglitazone in patients with congestive heart failure or history of congestive heart failure (New York Heart Association (NYHA) functional classification stages I to IV) as well as a warning