ARTICLE | Company News
Avandia, Actos get black boxes
August 15, 2007 12:28 AM UTC
FDA said manufacturers of thiazolidinedione diabetes drugs will change the products' labels to include black box warnings against use in patients with heart failure. The warning emphasizes that the drugs may cause or worsen heart failure in certain patients. The drugs include Avandia rosiglitazone, Avandaryl rosiglitazone/glimepiride and Avandamet rosiglitazone/metformin from GlaxoSmithKline (LSE:GSK; GSK), and Actos pioglitazone and Duetact pioglitazone/glimepiride from Takeda (Tokyo:4502). The companies said in June that they would comply with FDA's request, which the agency made in May. ...