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Manufacturers of some diabetes drugs to strengthen warning on heart failure risk.(Industry News)

Pharmaceutical Processing

| September 01, 2007 | COPYRIGHT 2009 Advantage Business Media. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

The FDA recently announced that manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning--FDA's strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.

After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes…

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