FDA was under immense pressure in 2010 to ban the use of diabetes drug, Avandia manufactured by GlaxoSmithKline. FDA did not issue ban, but asked GSK to make labeling changes with restriction on use of drug rosiglitazone (Avandia). The changes were results of meta analysis from studies that exhibited increased risk of heart attack in people taking Avandia.
The new label restricts use of Avandia to the patients that are unable to take other antiglycemic drugs or “are unable to achieve adequate glycemic control on other diabetes medications, and, in consultation with their healthcare provider, have decided not to take pioglitazone (Actos) for medical reasons.”
The following has been noted on the box warning for Avandia:
- highlight the increased cardiovascular risks associated with rosiglitazone.
- The data from a meta-analysis from 52 earlier studies is cited.
- three stand alone trials that found high rates of MI in patients taking rosiglitazone versus placebo or another comparator drug are also cited.
- The warning also notes that rosiglitazone has not been compared with pioglitazone in a head-to-head study of cardiovascular risks; however, a placebo-controlled trial of the latter drug did not indicate an increase in MI...
- previous language related to heart failure and associated conditions, such as edema and fluid retention was expanded. Patients with NYHA class III or IV heart failure should not receive rosiglitazone, and the drug may increase other cardiovascular risks in patients with milder forms of heart failure.
GSK is persistently working with the FDA regarding analysis of data from RECORD trial, which was criticized for questionable determinations of cardiovascular events patients in the trial may have experienced. Also, FDA wanted GSK should get written consent from patients that they have reviewed the cardiovascular safety concerns about the drug.