FDA to strengthen diabetes drug warnings

FDA says Glaxo, Takeda agree to heightened warnings of heart failure for Avandia, Actos.

By Aaron Smith, CNNMoney.com staff writer

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.

Avandia and Actos are used to help diabetics control blood-sugar levels. Top of page

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Most stock quote data provided by BATS. Market indices are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer.

Morningstar: © 2014 Morningstar, Inc. All Rights Reserved.

Factset: FactSet Research Systems Inc. 2014. All rights reserved.

Chicago Mercantile Association: Certain market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved.

Dow Jones: The Dow Jones branded indices are proprietary to and are calculated, distributed and marketed by DJI Opco, a subsidiary of S&P Dow Jones Indices LLC and have been licensed for use to S&P Opco, LLC and CNN. Standard & Poor's and S&P are registered trademarks of Standard & Poor’s Financial Services LLC and Dow Jones is a registered trademark of Dow Jones Trademark Holdings LLC. All content of the Dow Jones branded indices © S&P Dow Jones Indices LLC 2014 and/or its affiliates.