FDA to strengthen diabetes drug warnings
FDA says Glaxo, Takeda agree to heightened warnings of heart failure for Avandia, Actos.
NEW YORK (CNNMoney.com) -- The FDA said on Tuesday that GlaxoSmithKline and Takeda agreed to strengthen heart failure warnings on their diabetes drugs, Avandia and Actos.
These drugs already carry warnings of heart failure risk, but the Food and Drug Administration wants the label to include information for physicians about monitoring patients for signs of heart failure.
Glaxo's (down $1.04 to $50.51, Charts) Avandia and Takeda's Actos are members of the TZD class of drugs, which has come under scrutiny in recent months, following a "meta-analysis" published by Dr. Steven Nissen, chief cardiologist for the Cleveland Clinic, in the New England Journal of Medicine.
Despite concerns over Avandia, FDA advisors in July voted to keep the drug on the market.