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FDA Issues Actos® Warning

On August 14, 2007, the U.S. Food and Drug Administration (FDA) announced that the makers of Actos® will place more prominent black box warnings on its labels advising doctors and patients of the increased risks for heart failure and other cardiovascular problems.

Actos Bladder Cancer Lawsuit Update April 8, 2014: In the first U.S. trial of its kind, Takeda Pharmaceuticals and Eli Lilly were ordered to pay a total of $9 billion in punitive damages after a jury agreed that the companies failed to warn the public and medical communities about the bladder cancer risk associated with their controversial type 2 diabetes drug Actos (pioglitazone). The lawsuit claimed that Takeda and Lilly downplayed or ignored concerns about Actos’ link to bladder cancer, and mislead health authorities in order to protect profits. Click here to learn more.

Free Actos FDA Warning Case Evaluation: If you or a loved one has experienced severe side effects as a result of taking Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

Actos 2007 FDA Warning

In 2007, the U.S. FDA announced manufacturers of certain drugs approved to treat Type 2 diabetes would add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information was to be included in the form of a “boxed” warning – FDA’s strongest form of 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 anti-diabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepiride). These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. FDA had asked the drug’s manufacturers, GlaxoSmithKline and Takeda, to address these concerns.

The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.

To read the official FDA warning letter, please visit the U.S. Food & Drug Administration’s website: http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm109136.htm

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