Actos Lawsuit
If you have suffered a personl injury as a result of the dangerous drug Actos, you may be eligble for compensation and should contact an attorney who specializes in product liability litigation and dangerous drug litigation against pharmaceutical companies.
Actos Can Cause Heart Failure
- Thiazolidinediones, including Actos, Actoplus Met, and Duetact, may cause or exacerbate congestive heart failure in some patients.
- Initiation of these drugs in patients with established NYHA Class III or IV heart failure is contraindicated.
- After initiation of Actos, Actoplus Met, and Duetact, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema).
- If these signs and symptoms develop and heart failure is confirmed, appropriate management of heart failure should be initiated. Discontinuation or dose reduction of Actos, Actoplus Met, or Duetact should be considered.
Actos Symptoms
- Patients should be informed that Actos, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure.
- Patients should be asked to watch for and report to their healthcare professional any signs and symptoms of heart failure, including edema from fluid retention, shortness of breath or trouble breathing, unusually fast increase in weight, and unusual tiredness.
Actos 2007 Warning from FDA
The U.S. Food and Drug Administration today announced 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 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.
"Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure."
FDA's review of adverse event reports found cases of significant weight gain and edema - warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death.
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.
The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.
