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Avandia® – produced by GlaxoSmithKline (GSK) – regulates and controls the blood-sugar levels of patients who have been diagnosed with Type-2 (non-insulin-dependent) diabetes. Avandia® has been the subject of deep controversy, due to the fact that of a number of studies have concluded that using the product as a treatment for Type-2 diabetes may increase the possibility of death, heart-attack, heart-failure, and bone fracture. Avandia®: Serious Problems In May 2007, the Food and Drug Administration (FDA) issued to health-care professionals in the U.S. a warning that described the risks that could develop from prescribing Avandia® as a form of diabetic treatment – that included significantly elevated risks of both heart-attack and heart-failure. Six months later, in November 2007, the FDA said that "the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks." "FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines." The FDA added: "During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia. "At this time, FDA has concluded that there isn't enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly. "The revision of Avandia's existing boxed warning – FDA's strongest form of warning – includes the following statement: "A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive. "The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients. "GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia. "To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit." The FDA concluded: "Today's action follows recommendations made at the July 2007 joint meeting of FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling." Using Avandia® to help control Type-2 diabetes has also been blamed for bone fractures in a number of patients. In some patients prescribed Avandia®, the risk of bone fracture may be three-times that of patients not prescribed the drug. Have You Been Injured by Avandia®? If you have been injured by Avandia®, you may have grounds for a lawsuit. Avandia® Lawsuits If you or a loved one has suffered from serious, life-threatening conditions that may have resulted after taking Avandia® as a treatment for diabetes, and you have questions about Avandia® lawsuits, contact DrugRxRecall immediately. We will be pleased to refer you to a skilled and experienced lawyer who can offer you a free consultation, information and advice on potential lawsuits relating to accidents, injuries and deaths caused by the side-effects of Avandia®. The lawyers we work with are highly motivated and knowledgeable. They can advise you on the options available to you if you feel you have grounds for an Avandia® lawsuit. Do not hesitate to contact us immediately for information on Avandia® lawsuits.
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