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Avandia News
Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
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 Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). 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. FDA’s review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA’s Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).
Pharmaceutical Processing
Advantage Business Media
FDA advisory panel votes for Avandia to be available in US
Source : Moneycontrol.com
2007-08-06 - GlaxoSmithKline today welcomed the nearly unanimous recommendation of an U.S. Food and Drug Administration’s (FDA) advisory committee to support Avandia’s (rosiglitazone maleate, marketed in India by GSK Pharmaceuticals as Windia) continued availability to patients in the US. The company said it will continue to provide information to the FDA to assist in the Agency’s final decision-making.
On July 30th, the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted that the data suggests some ischemic risk with Avandia, a treatment for type 2 diabetes. The committee declined to comment on comparative risk of Avandia to other oral anti-diabetic medicines. The committee also voted to keep the medicine available to patients in the US. The FDA will review the panel’s recommendation before making a decision.
Commenting on the development, Dr. Sadhna Joglekar, Vice-President, Medical Affairs & Clinical Research, GSK Pharmaceuticals India said, “We are very pleased with the outcome of the scientific deliberations of the Advisory Committee. The verdict of the Committee will ensure that Windia will continue to be available in India and provide sustained glycemic control to diabetic patients as it has in the past”.
“We welcome this decision as positive for patients. This was the first opportunity for these scientific experts to review the full data behind Avandia. The committee recognized the debilitating nature of this disease and the importance of multiple treatment options,” said Dr. Ronald Krall, Chief Medical Officer, GlaxoSmithKline. “Diabetes is a progressive disease that exacts a terrible toll on its victims, and it is important that Avandia remain a treatment option for patients.”
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